Walking with age becomes both slower and less 'automated', requiring more attention and brain resources. As a result, older adults have a greater risk of negative outcomes and falls. There is an urgent need to identify factors that can help compensate for these harmful factors and reduce walking impairments, as there are currently no effective treatments available. Investigators have recently discovered that
20% of older adults maintain fast walking speed even in the presence of small blood vessel brain changes and leg problems, thus appearing to be protected against these harmful factors. The investigators work suggests that the brain dopamine (DA) system may be a source of this protective capacity. Investigators have also shown that lower levels of dopamine are associated with slow walking. Investigators will be investigating the role of dopamine on slow walking and other parkinsonian signs in this open-label study using detailed clinical assessment, assessment of dopamine activity, and clinical interventions.

开始日期2024-10-29

申办/合作机构

University of Michigan

[+1]

NCT06626152

/ Recruiting临床2期IIT

Measuring Psychomotor Response to L-DOPA Challenge As a Biomarker for Outcomes in Late-Life Depression: a Pilot Feasibility Trial

Background
Adults over the age of 60 with symptoms of major depressive disorder are said to have late-life depression (LLD), a condition that usually decreases a person's quality of life and is associated with other risks like physical frailty and dementia. A common feature of more severe LLD is psychomotor slowing, where a person's ability to think and move are impaired. For example, they might not be able to walk or process information as quickly, and they might have problems with their working memory.
Psychomotor slowing in LLD might be the result of a problem with the way a person's body produces or responds to the neurotransmitter dopamine. The drug Levodopa (L-DOPA), which can replace missing dopamine in the brain, has been used to treat to treat Parkinson's disease for many decades, and it might also affect psychomotor slowing in LLD.
Methods
In this study, participants are adults aged 60 years or older with moderate to severe major depression. Participants undergo the "L-DOPA challenge"-a 2-week period where they receive a dose of L-DOPA once a day for the first week and a dose of L-DOPA twice a day for the second week. Before and after a participant completes the L-DOPA challenge, the study team assesses their depressive symptoms and psychomotor function. After the L-DOPA challenge, if a participant still shows signs of moderate or severe depression, they receive an antidepressant for 12 weeks.
Aims
The first aim of this study is to test the feasibility of the L-DOPA challenge-that is, whether most of the 50 participants recruited for this study will complete the L-DOPA challenge. For example, participants might have to withdraw if they can't make the daily visits to the research site to receive their L-DOPA medication, if they can't tolerate the medication's side effects, or if their depressive symptoms get significantly worse. Our hypothesis is that 80% of the participants will complete the L-DOPA challenge.
The second aim of the study is to see if L-DOPA affects participants' depressive symptoms, processing speed, and working memory. Our hypothesis is that L-DOPA response, measured as an improvement in gait speed, is associated with a decrease in depressive symptoms and an increase in processing speed and working memory.

开始日期2024-08-15

申办/合作机构

University of British Columbia

[+1]

NCT06219915

/ Completed临床1/2期IIT

Neurobiological Drivers of Mobility Resilience: The Dopaminergic System

Walking with age becomes both slower and less 'automated', requiring more attention and brain resources. As a result, older adults have a greater risk of negative outcomes and falls. There is an urgent need to identify factors that can help compensate for these harmful factors and reduce walking impairments, as there are currently no effective treatments available. Investigators have recently discovered that
20% of older adults maintain fast walking speed even in the presence of small blood vessel brain changes and leg problems, thus appearing to be protected against these harmful factors. The investigators work suggests that the brain dopamine (DA) system may be a source of this protective capacity. Investigators have also shown that lower levels of dopamine are associated with slow walking. Investigators will be investigating the role of dopamine on slow walking and other parkinsonian signs in this double-blinded, placebo-controlled study using detailed clinical assessment, assessment of dopamine activity, and clinical interventions.

开始日期2024-03-15

申办/合作机构

University of Michigan

[+1]

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100 项与卡比多巴相关的专利（医药）

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3,678

项与卡比多巴相关的文献（医药）

2025-05-01·International Immunopharmacology

Clinical study to investigate the adjuvant role of Pentoxifylline in patients with Parkinson's disease: A randomized controlled study

Article

作者: El-Haggar, Sahar M ; Khrieba, Mohannad O ; Hegazy, Sahar K ; Mohammed, Wessam Fathi

BACKGROUNDParkinson's disease (PD) is a common neurodegenerative disease characterized by the loss of dopaminergic neurons in the par's compacta of the substantia nigra. A lot of studies have since been carried out on the neuroinflammation linked to the pathophysiology of PD, including elevated levels of proinflammatory cytokines. Preclinical studies proved the efficacy of pentoxifylline (PTX) in PD.AIMTo assess the neuroprotective and anti-inflammatory effects of PTX in patients with PD.METHODSSixtytwo Patients were randomly assigned to two groups (n1 = 30, and n2 = 32); the PTX group received conventional treatment for Parkinson's disease, levodopa/carbidopa, plus PTX 400 mg twice daily, whereas the control group received conventional treatment only. Every patient was assessed by a neurologist both at the start of treatment and six months thereafter. Every patient is evaluated using the Unified Parkinson's disease rating scale (UPDRS). Adenosine monophosphate activated protein kinase (AMPK), reduced glutathione (GSH), high mobility group box protein (HMGB1), and mammalian target of rapamycin (mTOR) were measured both before and after therapy. The statistical analysis within and between groups was evaluated using direct and indirect t-tests, respectively.RESULTSThe PTX group revealed a statistically significant decrease in the level of assessed variables as followed: mTOR (p = 0.037), HMGB-1 (p = 0.029), and a significant increase in GSH (p = 0.016) and AMPK (p = 0.027), when compared to the control group. Additionally, the PTX group had a significantly reduced UPDRS. (p < 0.05).CONCLUSIONPTX may be suggested as a promising adjuvant anti-inflammatory medication for Parkinson's disease treatment.CLINICAL TRIAL IDENTIFIERNCT05962957.

2025-05-01·Biomedicine & Pharmacotherapy

Combining vinpocetine or cocoa with levodopa, Coenzyme Q10 and vitamin B complex mitigates rotenone-induced Parkinson’s disease in rats: Impact on Nrf2/HO-1, NF-kB, AMPK/SIRT-1/Beclin-1, AKT/GSK-3β/CREB/BDNF and Apoptotic Pathways

Article

作者: Elsanhory, Heba M A ; Abbas, Ashwaq N ; Abu-Elfotuh, Karema ; Atwa, Ahmed M ; Hamdan, Amira M ; Alkhamali, Alanoud ; Gowifel, Ayah M H ; Abdelhakim, Khaled R ; Alharthi, Fatimah Ali ; Negm, Amira M ; Al-Rekabi, Mohammed D ; Hamdan, Ahmed M E ; Elshahat, Rehab M ; Darwish, Alshaymaa

There are no curative treatments for Parkinson's disease (PD), and current treatments focus on symptomatic management. This study aimed to investigate the beneficial effects of combining L-DOPA/Carbidopa with essential cofactors (vitamin (VIT) B complex and coenzyme Q10 (CoQ10)), alone or in conjunction with vinpocetine (VIN) or cocoa, as a potential strategy to enhance neuroprotection in rotenone (RT)-induced PD rat model, highlighting mechanistic insights into their underlying neuroprotective mechanisms and focusing on addressing oxidative stress, inflammation, autophagy, and apoptosis. These combinations were tested on adult male Wistar rats allocated into six groups. Group I received saline (normal control), while groups II-VI were injected with RT for 19 days to induce PD. Group II received RT alone, group III received daily oral L-DOPA/Carbidopa, and groups IV-VI received L-DOPA/Carbidopa with VIT B complex and CoQ10, either alone (Group IV) or combined with cocoa (Group V) or VIN (Group VI). These treatments markedly improved RT-induced perturbations in locomotor and cognitive outcomes; neurotransmitters' levels; oxidative stress (Nrf2/HO-1, MDA, INOS, SOD and TAC); inflammatory (NF-κB, TNF-α, IL-1β, GFAP and COX-2); neurotrophic (AKT/CREB/BDNF); apoptotic (BAX, caspase-3, AIF, and Bcl-2); and autophagic (AMPK/SIRT-1/Beclin-1) biomarkers; histopathological findings and tyrosine hydroxylase (TH) immunoexpression. Furthermore, the best outcomes were observed in cocoa and VIN combinations. These results indicated that combining L-DOPA with CoQ10 and VIT B complex in conjunction with either VIN or cocoa could provide a potential strategy for managing motor impairments and preventing neurodegeneration in PD. The interaction between key signaling pathways, including Nrf2/HO-1, NF-kB, AMPK/SIRT-1, and AKT/GSK-3β/CREB/BDNF, likely mediates this effect. However, further clinical validation is required to assess this approach's real-world applicability and therapeutic potential.

2025-05-01·Neurological Sciences

Subcutaneous administration of foslevodopa/foscarbidopa (PRODUODOPA®) in arm and thigh due to giant epigastric hernia: a case report

Article

作者: Telarović, Srđana ; Čondić Jurjević, Lucija

BACKGROUNDPRODUODOPA^® is a combination of foscarbidopa and foslevodopa indicated for the treatment of motor fluctuations in patients with advanced Parkinson's disease when available combinations of peroral drugs have not given satisfactory results. The solution is administered via subcutaneous infusion, most frequently in the abdomen, using an infusion pump. The study results showed a significant effect on the reductions in off time and higher control of motor symptoms without troublesome dyskinesia.CASE DESCRIPTIONA 61-year-old man on long-term oral therapy for Parkinson's disease presented with frequent wearing-off phenomenon, daily freezing episodes and occasional episodes of severe nocturnal akinesia. Due to giant epigastric hernia PRODUODOPA was administered subcutaneously in upper arm and thigh. The use of the pump resulted in an excellent therapeutic effect with a reduction in motor fluctuations and an improvement in the patient's quality of life. From the available medical literature, the use of the drug in the limb area has not been described so far.CONCLUSIONPRODUODOPA can be administered subcutaneously in the area of the upper and lower extremities with just as good results as after subcutaneous infusion in abdomen.

274

项与卡比多巴相关的新闻（医药）

2025-04-22

·PRNewswire

XADAGO/EQUFINA Set to Revolutionize Parkinson's Disease Treatment Landscape | DelveInsight

As a selective monoamine oxidase B (MAO-B) inhibitor, XADAGO offers a unique mechanism of action that complements traditional therapies, potentially improving motor function and reducing "off" time in patients. The increasing prevalence of Parkinson's disease and the growing demand for effective therapies create a substantial market opportunity for XADAGO, particularly in regions with aging populations. LAS VEGAS, April 22, 2025 /PRNewswire/ -- DelveInsight's " XADAGO/EQUFINA Market Size, Forecast, and Market Insight Report" highlights the details around XADAGO/EQUFINA, an inhibitor of monoamine oxidase B (MAO-B) indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of XADAGO/EQUFINA. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Newron Pharmaceuticals/Eisai/Meiji Seika Pharma's XADAGO/EQUFINA (safinamide) Overview XADAGO is a monoamine oxidase B (MAO-B) inhibitor used alongside levodopa/carbidopa to help manage "off" episodes in individuals with Parkinson's disease. While its exact mode of action in treating Parkinson's is not fully understood, it is thought to work by inhibiting MAO-B, thereby reducing dopamine breakdown. This leads to increased dopamine levels and enhanced dopaminergic activity in the brain. XADAGO contains the active ingredient safinamide in the form of a mesylate salt and is available in 50 mg and 100 mg film-coated oral tablets. Each tablet provides either 65.88 mg or 131.76 mg of safinamide mesylate, equivalent to 50 mg or 100 mg of the safinamide base. The medication is marketed as XADAGO in the United States and Europe and under the name EQUFINA in Japan. Learn more about XADAGO/EQUFINA projected market size for Parkinson's disease @ XADAGO/EQUFINA Market Potential Parkinson's disease is a progressive neurological disorder that mainly impairs movement control. It results from the slow degeneration of dopamine-producing neurons in the brain, especially in the substantia nigra, a region crucial for managing voluntary motor function. According to estimates by DelveInsight, there were 2.7 million diagnosed prevalent cases of Parkinson's disease in the 7MM in 2023, with the United States accounting for around 45% of these cases. While a cure for Parkinson's remains elusive, a combination of pharmacological and non-pharmacological therapies is used to manage symptoms. Physical, occupational, and speech therapies form key components of treatment, and surgical procedures may benefit select patients. Additionally, complementary therapies are sometimes employed to help address particular symptoms. Frequently prescribed medications for Parkinson's include levodopa, dopamine agonists, MAO-B inhibitors, COMT inhibitors, amantadine, anticholinergics, and adenosine A2A antagonists. These treatments primarily target motor symptoms, which are a major concern for those affected. DelveInsight reports that the Parkinson's disease market in the 7MM was valued at USD 3.2 billion in 2023. The market is expected to grow over the forecast period (2020–2034), fueled by the launch of new therapies, increasing prevalence, better access to healthcare, and rising demand for more advanced and effective treatment options. Discover more about the Parkinson's disease market in detail @ Parkinson's Disease Market Report Emerging Competitors of XADAGO/EQUFINA Some of the drugs in the pipeline include Solengepras (Cerevance), Minzasolmin (UCB Biopharma SRL/Novartis), Buntanetap (Annovis Bio), and others. Buntanetap has successfully completed Phase III trials for early-stage Parkinson's disease. Annovis Bio has scheduled a meeting with the FDA in Q1 2025 to determine the development path forward for Buntanetap in the treatment of Parkinson's disease. Buntanetap is also being developed for Alzheimer's disease, Lewy Body Dementia, and other neurodegenerative disorders. In November 2024, Cerevance announced the dosing of the first patient in its pivotal Phase III ARISE trial, evaluating solengepras as a potential adjunctive treatment for Parkinson's disease. Cerevance expects to report topline data in the first half of 2026. In December 2021, UCB partnered with Novartis to globally co-develop and co-commercialize UCB0599, a pioneering alpha-synuclein misfolding inhibitor currently in Phase II clinical trials for Parkinson's disease. To know more about the number of competing drugs in development, visit @ XADAGO/EQUFINA Market Positioning Compared to Other Drugs Key Milestones of XADAGO/EQUFINA In April 2020, Newron Pharmaceutical acknowledged that US WorldMeds, who held the US commercialization rights for the licensed drug, XADAGO, as a sub licensee of Zambon, had entered into a definitive agreement with Supernus Pharmaceuticals under which Supernus would acquire the CNS portfolio of US WorldMeds, including the US rights to XADAGO In November 2019, Eisai announced that it had launched the EQUFINA 50mg tablets for the indication of improvement of the wearing-off phenomenon in patients with Parkinson's disease under treatment with a drug containing levodopa in Japan. Manufacturing and marketing approval of EQUFINA was obtained in September 2019. In April 2017, Eisai Co., Ltd. and Meiji Seika Pharma announced entering into a license agreement for the commercialization of safinamide (development code: ME2125) to treat Parkinson's disease in Japan and Asia. In March 2017, Newron Pharmaceuticals announced the US FDA approval of XADAGO to treat Parkinson's disease as an add-on therapy to levodopa/carbidopa for patients experiencing "off" episodes. In March 2016, Zambon announced a strategic agreement with US WorldMeds to commercialize Newron's lead compound, XADAGO, to treat Parkinson's disease in the US. In February 2015, XADAGO was approved in the European Union as an add-on therapy to levodopa, alone or in combination with other Parkinson's medications, in mid-late stage PD patients with motor fluctuations. XADAGO/EQUFINA Patent Details XADAGO tablets are currently protected by three XADAGO patents with US patent numbers 8,076,515, 8,278,485, and 8,283,380, which expire between June 2027 and December 2028 and are listed in the FDA's publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book. The company has a license agreement with Zambon S.p.A., Newron's partner, related to the XADAGO Patents, and as a new chemical entity, XADAGO is under the 5-year FDA exclusivity period that expires on March 21, 2022. In May 2017, Zambon filed a worldwide patent under the patent number WO2017207587A1. The invention relates to pharmaceutical compositions comprising safinamide and, more particularly, to taste-masked particles comprising said active ingredient or pharmaceutically acceptable salts thereof, oral dosage forms that include said particles, and a process for preparing them. Discover how XADAGO/EQUFINA is shaping the Parkinson's disease treatment landscape @ XADAGO 50mg XADAGO/EQUFINA Market Dynamics XADAGO, marketed as EQUFINA in some regions (notably in South Korea and Japan), is a once-daily oral selective MAO-B inhibitor used as an add-on treatment for Parkinson's disease patients experiencing "off" episodes while on a stable dose of levodopa. The drug's unique dual mechanism of action—MAO-B inhibition and modulation of glutamate release—offers both dopaminergic and non-dopaminergic effects, positioning it as a differentiated product in the PD adjunctive therapy landscape. This has helped it carve a niche in markets where patients are inadequately controlled by levodopa alone, particularly those in mid-to-late-stage PD. The global market dynamics for XADAGO/EQUFINA are shaped by a mix of competitive intensity, regional adoption trends, and payer dynamics. In the U.S. and Europe, the drug has faced stiff competition from generic MAO-B inhibitors (like selegiline and rasagiline) and newer Parkinson's disease therapies, including COMT inhibitors, dopamine agonists, and extended-release levodopa formulations. Despite this, its favorable safety profile and once-daily dosing have supported its uptake in certain patient segments, especially in Europe. Market penetration has been slower in the U.S. due to both reimbursement hurdles and physician preference for more established adjunctive treatments. In Asia, particularly Japan and South Korea, EQUFINA has demonstrated stronger market performance thanks to focused commercial strategies and a high unmet need for effective "off time" management. Meiji Seika Pharma and Eisai, the regional marketing partners, have successfully leveraged the drug's differentiated profile in clinician education, which has led to growing adoption among neurologists. In Japan, where the aging population is rapidly expanding and Parkinson's prevalence is rising, EQUFINA has benefited from both demographic tailwinds and formulary access. Looking ahead, the market outlook for XADAGO/EQUFINA depends on several strategic levers, including lifecycle management, regional partnerships, and real-world evidence generation. The manufacturer's ability to expand into new geographies, secure favorable reimbursement, and differentiate against both generics and newer entrants will be critical. Moreover, as Parkinson's disease treatment moves toward more personalized approaches, XADAGO/EQUFINA may find sustained relevance in specific subpopulations, particularly those requiring a balance of efficacy and tolerability. Dive deeper to get more insight into XADAGO/EQUFINA's strengths & weaknesses relative to competitors @ XADAGO/EQUFINA Market Drug Report Table of Contents Related Reports Parkinson's Disease Market Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease companies, including UCB Biopharma SRL, Novartis, Annovis Bio, Supernus Pharmaceuticals, Inc., Britannia Pharmaceutical, Pharma Two B, Mitsubishi Tanabe Pharma (NeuroDerm), AbbVie, Cerevel Therapeutics, Cerevance, among others. Parkinson's Disease Pipeline Parkinson's Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Parkinson's disease companies, including Cerevel Therapeutics, Inhibikase Therapeutics, Neuraly, Peptron, Biogen, Roche, Brain Neurotherapy Bio, Inc., Modag, Annovis Bio Inc., BioVie Inc., United Neuroscience Ltd., Luye Pharma Group, AbbVie, UCB Biopharma SRL, InnoMedica Schweiz AG, Integrative Research Laboratories AB, H. Lundbeck A/S, Shanghai WD Pharmaceutical Co., Ltd., Cerevance Beta, Inc., Nobilis Therapeutics Inc., BlueRock Therapeutics, Taiwan Mitochondrion Applied Technology Co., Ltd., among others. Cell and Gene Therapy in Parkinson's Disease Market Cell and Gene Therapy in Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key cell and gene therapy in Parkinson's disease companies including MeiraGTx, Hope Biosciences, Sumitomo Pharma, Prevail Therapeutics, BlueRock Therapeutics, Voyager Therapeutics, among others. Parkinson's Disease Psychosis Market Parkinson's Disease Psychosis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease psychosis companies, including Sumitomo Pharma America Inc., Vanda Pharmaceuticals, Acadia Pharmaceuticals Inc., Otsuka America Pharmaceutical, Lundbeck LLC, Jazz Pharmaceuticals, Alkahest Inc., Sandoz, Sio Gene Therapies, Axovant Sciences Ltd, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期上市批准引进/卖出临床2期

2025-04-14

·微信

2025 MDS 运动波动循证建议更新解读

帕金森病（PD）患者在长期使用左旋多巴治疗后，超过80%的患者最终会出现症状波动（如 “关期” 延长、“开期” 缩短、剂末现象等）1。在另一项国内的研究中，接受左旋多巴治疗的中国患者在近1年内有29.0%出现症状波动，而10年以上人群中症状波动的发生率则高达68.3%2。在一项针对帕金森患者的问卷调查中，高达66.3%的患者认为改善症状波动非常重要3。因此，对帕金森患者的症状波动现象进行更好的管理对改善患者的生活质量有很重要的意义。为了更好地协助医生们针对患者个体选择合适的治疗方案，MDS（International Parkinson and Movement Disorder Society，国际帕金森和运动障碍学会）在2002年第一次基于循证医学证据发表了选择治疗方法的建议，而且之后也在定期更新，最近一次的更新是在2018年。截至目前，针对帕金森病运动症状的治疗方案仍然在不断增加，多项临床试验结果也在陆续发表。因此在2025年，MDS基于102项随机对照试验（RCT，randomized controlled trial），采用了新的评估方法，系统评估了现有治疗手段（包括药物和手术）的有效性与安全性，为临床决策提供了重要参考（图1）4。图1在文章中，针对每一项干预措施的疗效评价都采用了两个维度：（1）结局的临床相关性（the clinical relevance of the outcome）；（2）证据质量（the quality of the evidence）。为了确定临床结局的相关性，如果有临床数据，就会使用相应量表上的最小临床重要差异（MCID，minimal clinically important differences）。对于 “开期” 时长、“关期” 时长以及无异动症的时间长度，最小临床重要差异为每天1小时5。而对于PDQ-39（帕金森病问卷 - 39 项，Parkinson's Disease Questionnaire - 39），最小临床重要差异为5分6。在证据质量方面，采用改良的GRADE方法（modified version of Grading of Recommendations, Assessment, Development, and Evaluations)，基于偏倚风险、不精确性、不一致性、间接性以及发表偏倚的可能性，对每一项干预措施有效性的证据质量进行评估（图2）。图2沙非胺（既往称沙芬酰胺，safinamide）是新一代的MAO-B（ B型单胺氧化酶，monoamine oxidase B）抑制剂，并且是所有药物中唯一的具有双重作用机制抗帕金森的药物。沙非胺除了通过抑制MAO-B对多巴胺递质的分解代谢外，还可以通过阻滞离子通道的途径来抑制过量谷氨酸的释放来改善帕金森患者的症状7。该篇文献经过筛查最终纳入了4项与沙非胺相关的RCT8-11。在4项RCT中，对比评估了沙非胺和安慰剂之间对于改善“开期”和“关期”时间的疗效。全部试验都观察到了具有临床意义的“关期”时间减少（相比安慰剂组减少约1h），并且增加了不伴有令人困扰的运动障碍的“开期”时间（相比安慰剂组增加约1h），显示了沙非胺对于症状波动者的优越疗效。在PDQ-39评分表方面，其中1项研究8显示沙非胺达到了改善日常生活质量的阈值，另一项研究9提示在沙非胺100mg组中，对于安慰剂，PDQ-39评分的改善也超过了5分的阈值均提示了其在改善帕金森病患者日常生活质量的作用。另一方面，值得注意的是MDS目前基于现有研究认为，沙非胺是唯一具有双重作用机制（MAO-B抑制和通道阻滞）的抗帕金森药物。而且在药物有效性方面，相比于前两代MAO-B阻滞剂司来吉兰和雷沙吉兰，其对于症状波动的改善有更高程度的证据支持（沙非胺为有效，司来吉兰为证据不足，雷沙吉兰为可能有效）。并且唑尼沙胺（zonisamide）不再被认为是双机制治疗药物，其对症状波动的有效性方面，MDS也基于最新证据也将其从有效调整为可能有效（图3）。图3此外，IPX 066, ER（卡比多巴 / 左旋多巴缓释剂，Levodopa Carbidopa Extended – Release，IPX 066为其研究代码）在治疗症状波动上也有令人满意的效果，而且是唯一被MDS认为有效的Levodopa/PDI（左旋多巴 / 外周脱羧酶抑制剂）类药物。文中参考了1篇发表于2013年的RCT12。该研究发现IPX 066相比对照组在减少“关期”时间上有明显优势（约1.2 h ，P < 0.0001），并且在“开期”时间上也有明确改善（不伴令人困扰的运动障碍的“开期”时间为0.9 h, P < 0.001；不伴任何运动障碍的“开期”时间为0.7 h, P < 0.05）（图4）。图4在外科治疗方面，MDS也对各种治疗方式的临床有效性做了较大的调整。当前，Bilateral STN DBS（Bilateral Subthalamic Nucleus Deep Brain Stimulation，双侧丘脑底核脑深部电刺激术）是唯一被MDS认为有效的术式。而在上一版推荐中同样被认为有效的Bilateral GPi DBS（Bilateral Globus Pallidus Internus Deep Brain Stimulation，双侧苍白球内侧部脑深部电刺激术）和Unilateral pallidotomy（单侧苍白球切开术）现已被调整为可能有效（图5）。图5时隔7年 MDS 从数据库中15485篇相关文章最终筛选了102项高质量 RCT，并且采用了新的方法来对所有纳入的文章进行治疗有效性分析和证据质量分级。随着时间推移、新药的开发和更多临床试验结果的发表，人们对于帕金森运动波动的理解和治疗观念也随之发生改变：IPX 066成为唯一达到有效级别的 Levodopa/PDI 类药物、普拉克索和罗替高汀的治疗地位仍然稳固、恩他卡朋和雷沙吉兰的有效性级别下降、沙非胺成为唯一有效的双机制药物、唑尼沙胺在有效性级别下降的同时也不再被认为具有通道阻滞的作用、 Bilateral STN DBS是当前证据最充分的针对运动波动症状的手术方案。未来随着更多新药的开发和临床试验的进行，治疗的选择仍然可能会出现变化。 MDS最新的循证医学建议确认了沙非胺对于帕金森病症状波动治疗的有效性。作为新一代的MAO-B抑制剂，沙非胺可以抑制MAO-B对于多巴胺递质的代谢，同时调节钠离子和钙离子通道抑制过量谷氨酸的释放，通过目前唯一的双重抗帕金森机制，可以明显减少“关期”时间并且增加不伴有令人困扰的运动障碍的“开期”时间，其在改善PDQ-39评分方面也有一定的优势，并且对于非运动症状也有明显的改善作用13-15。在帕金森病的治疗中，尤其是出现运动并发症的患者，沙非胺将会是很有优势的选择。参考文献1. Stocchi F, Antonini A, Barone P,et al. Early DEtection of wEaring off in Parkinson disease: the DEEP study. Parkinsonism Relat Disord. 2014 Feb;20(2):204-11. 2. Wan Y, Yuan C. Hou X, et al. Wearing-off Identification in Parkinson's Disease: The shapd-woq Study. Front Neurol. 2020 Mar 13:11:116.3. Wüllner U, Fuchs G, Reketat N, et al. Requirements for Parkinson's disease pharmacotherapy from the patients' perspective: a questionnaire-based survey. Curr Med Res Opin. 2012 Jul;28(7):1239-46. study. Parkinsonism Relat Disord. 2014 Feb;20(2):204-11. 4. de Bie RMA, Katzenschlager R, Swinnen BEKS, Peball M, Lim SY, Mestre TA, Perez Lloret S, Coelho M, Aquino C, Tan AH, Bruno V, Dijk JM, Heim B, Lin CH, Kauppila LA, Litvan I, Spijker R, Seppi K, Costa J, Sampaio C, Fox SH, Silverdale MA. Update on Treatments for Parkinson's Disease Motor Fluctuations - An International Parkinson and Movement Disorder Society Evidence-Based Medicine Review. Mov Disord. 2025 Mar 8. doi: 10.1002/mds.30162. Epub ahead of print. PMID: 40055961. 5. Hauser RA, Gordon MF, Mizuno Y, et al. Minimal clinically important difference in Parkinson’s disease as assessed in pivotal trials of pramipexole extended release. Parkinsons Dis 2014;2014: 467131. 6. Horvath K, Aschermann Z, Kovacs M, et al. Changes in quality of life in Parkinson’s disease: how large must they be to be relevant Neuroepidemiology 2017;48(1–2):1–8. 7. Calabresi p, Kulisevsky J. Safinamide as Add-on Therapy - Moving Beyond Dopamine for a Multifaceted Approach in Parkinson's Disease.European Neurological Review,2017:12(Suppl. 5):2-6. 8. Borgohain R, Szasz J, Stanzione P, et al. Randomized trial of safinamide add-on to levodopa in Parkinson’s disease with motor fluctuations. Mov Disord 2014;29(2):229–237. 9. Hattori N, Tsuboi Y, Yamamoto A, Sasagawa Y, Nomoto M. Efficacy and safety of safinamide as an add-on therapy to L-DOPA for patients with Parkinson’s disease: a randomized, double-blind, placebo- controlled, phase II/III study. Parkinsonism Relat Disord 2020;75:17–23. 10. Schapira AHV, Fox SH, Hauser RA, et al. Assessment of safety and efficacy of safinamide as a levodopa adjunct in patients with Parkinson disease and motor fluctuations: a randomized clinical trial. JAMA Neurol 2017;74(2):216–224. 11. Wei Q, Tan Y, Xu P, et al. The XINDI study: a randomized phase III clinical trial evaluating the efficacy and safety of safinamide as add-on therapy to levodopa in Chinese patients with Parkinson’s disease with motor fluctuations. CNS Drugs 2022;36:1217–1227. 12. Hauser RA, Hsu A, Kell S, et al. Extended-release carbidopa-levodopa (IPX066) compared with immediate-release carbidopa-levodopa in patients with Parkinson’s disease and motor fluctuations: a phase 3 randomised, double-blind trial. Lancet Neurol 2013;12(4): 346–356. 13. Cattaneo C, M¨uller T, Bonizzoni E, et al. Long-Term Effects of Safinamide on Mood Fluctuations in Parkinson's Disease. J Parkinsons Dis. 2017;7(4):629-634. 14. Cattaneo C, Barone P, Bonizzoni E, et al. Effects of Safinamide on Pain in Fluctuating Parkinson's Disease Patients: A Post-Hoc Analysis. J Parkinsons Dis. 2017;7(1):95-101. 15. García DS, López IC, Guerra CL,et al. Safinamide improves sleep and daytime sleepiness in Parkinson's disease: results from the SAFINONMOTOR study. Neurol Sci. 2022 Apr;43(4):2537-2544. 提示：本材料仅供医疗卫生专业人士进行医学科学交流，不用于推广目的。

临床研究临床结果

2025-04-11

·医药地理

世界帕金森日看用药市场变局：多巴丝肼领跑、罗替高汀微球入局

2025年4月11日是第29个世界帕金森日，今年的主题是“人工智能助力帕金森病管理”。帕金森病（Parkinson's Disease, PD）作为典型的神经系统退行性疾病，主要影响中老年人。其病理特征是大脑中产生多巴胺的神经元逐渐退化和死亡，导致多巴胺分泌不足，从而引发一系列运动和非运动症状。据悉，帕金森病是增长最快的神经系统疾病，目前全世界已有超过1000万帕金森病患者，预计到2050年全球帕金森病患者数量可达到2500万人。患者主要表现为静止性震颤、运动迟缓、肌强直、自主神经功能障碍等症状，给患者本人及家庭带来了较大负担。药物分类及作用机制按照作用靶点分类，帕金森病治疗药物主要可以分为以下几类：uDDC（DOPA脱羧酶）：DDC催化左旋多巴转化为多巴胺，是多巴胺合成的关键步骤。通过抑制DDC，可以减少外周左旋多巴的代谢，使其更多地进入中枢神经系统，从而提高左旋多巴的疗效。uHTR（5-羟色胺受体）：主要在调节情绪和认知功能方面发挥作用，通过与多巴胺能系统相互作用，调节基底神经节的活动，从而改善运动功能，不仅如此，HTR拮抗剂可以减少左旋多巴诱导的异动症。uCOMT（儿茶酚-O-甲基转移酶）：COMT抑制剂通过抑制COMT酶的活性，减少左旋多巴在外周的代谢，延长其进入中枢神经系统的时间，从而提高左旋多巴的生物利用度。uDAT（多巴胺转运体）：DAT负责多巴胺的再摄取，通过抑制DAT，可以增加突触间隙中的多巴胺浓度，从而延长多巴胺的作用时间。uMAOB（单胺氧化酶B）：MAOB抑制剂通过抑制MAOB酶的活性，减少多巴胺的分解，从而延长其在基底神经节中的作用时间。此外，MAOB抑制剂还具有抗氧化和神经保护作用。uDRD（多巴胺受体）：DRD激动剂可直接激活多巴胺受体，模拟多巴胺的作用，缓解运动症状。uADOR2a（腺苷A2A受体）：ADOR2a拮抗剂通过阻断A2A受体，减少间接通路的过度兴奋性，从而改善帕金森病的运动症状。Pharma ONE智能药物大数据分析平台显示，目前全球已有41款（按通用名计）治疗帕金森病的药物上市，具体品种如下：图：全球已上市的帕金森病治疗药物来源：Pharma ONE智能药物大数据分析平台，中国医药工业信息中心药物竞争市场格局基于PDB药物综合数据库展开分析，2020年至2024年，帕金森病治疗药物院端市场呈现先降后升的状态，2020年—2022年整个市场规模呈现缩减趋势，2022年缩减至27.33亿元，自2023年出现回升，2024年回升至28.78亿元，同比增长率达到6.80%。图：2020年—2024年帕金森病治疗药物市场规模来源：PDB药物综合数据库国内院端放大板块，中国医药工业信息中心近五年来，帕金森病治疗药物的市场格局也出现了巨大变化，其中，左旋多巴+苄丝肼，复方（多巴丝肼）的市场份额实现了大幅提升，从14.82%增长到23.65%，跃居市场首位，2024年销售额更是达到了6.80亿。雷沙吉兰的市场份额也实现了快速增长，2024年已占据13.01%的市场份额，成功跻身市场前三。相比较之下，普拉克索的市场份额出现了大幅缩减，降幅更是超过了10%，痛失榜一宝座，苯海索、吡贝地尔、溴隐亭、卡比多巴+左旋多巴，复方更是掉出了榜单前十，市场份额大幅减少。图：2020年、2024年帕金森病治疗药物市场竞争格局来源：PDB药物综合数据库国内院端放大板块，中国医药工业信息中心除此之外，PDB药物综合数据库数据显示，2024年有44款用于治疗帕金森病的药物进入了国家医保常规目录，其中浙江京新药业股份有限公司、齐鲁制药（海南）有限公司、石药集团欧意药业有限公司、海思科制药（眉山）有限公司、江苏恒瑞医药股份有限公司的盐酸普拉克索（缓释）片中标，被纳入第四批国采。图：2024年被纳入医保及国采的帕金森病治疗药物来源：PDB药物综合数据库国内院端放大板块，中国医药工业信息中心研发进程目前，全球各大药企都有布局帕金森病治疗，全球已有上百款帕金森病治疗药物进入临床。在中国，已有罗替高汀、雷沙吉兰、普拉克索在内的5个品种（按通用名计）获批上市，用于帕金森病的药物治疗，国内更是有数十款创新药处于积极的临床开发阶段。据不完全统计，这些新药包括COMT抑制剂、LRRK2靶向抑制剂、线粒体自噬诱导剂等多种类型，其中几个比较具有代表性的药物如下：2024年6月，绿叶制药宣布其自主研发的创新微球制剂——金悠平®（注射用罗替高汀微球），作为纳入优先审评审批程序的品种，已获得中国国家药品监督管理局的上市批准，用于帕金森病的治疗，金悠平®基于绿叶制药全球领先的微球技术平台开发，每周给药一次，是全球首个治疗帕金森病的长效缓释微球制剂，也是目前更符合“持续多巴胺能刺激（CDS）”理念的周制剂。复星医药与Bial公司合作的奥吡卡朋胶囊，作为一种第三代COMT抑制剂，已提交上市申请。该药物自2016年在欧盟首次获批，作为左旋多巴/多巴脱羧酶抑制剂（DDCIs）的辅助治疗手段，适用于帕金森病患者，尤其是那些因剂量末期运动波动而无法稳定病情的成年患者。左旋多巴是治疗帕金森病的常用药物，但随着疾病进展到中晚期，患者单独使用左旋多巴可能会遇到疗效减退的问题。奥吡卡朋作为COMT抑制剂，通过抑制左旋多巴的分解，使其更多地进入大脑，从而增强治疗效果，改善症状。XS-411是由士泽生物研发的通用型iPS衍生多巴胺能神经前体细胞注射液，分别于今年2月和4月在美国和中国获得IND许可，用于治疗帕金森病。根据士泽生物的公开资料，该公司与合作医院共同开展的国家级备案临床研究中，临床级iPSC衍生细胞在患者纹状体壳核区移植治疗中重度帕金森病的最长随访期已超过12个月，未出现与细胞疗法相关的不良事件。此外，多项关键疗效指标如开关期时间和MDS-UPDRS评分量表，以及多项非运动指标均显示出显著改善。这些积极结果为后续临床试验的开展提供了重要依据和验证。目前，该产品针对帕金森病的1期临床试验正在有序进行中。帕金森病的治疗是一个任重道远的过程，在各大药企的努力下，期待未来有越来越多的新药获批上市用于治疗帕金森病。想要了解更多帕金森病有关内容？欢迎点击下方医药地理药研科普数字人短视频查阅有关内容。想要获得更多医药相关的数据信息吗？欢迎扫码使用数据库，开启属于你的数据检索之旅！END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

申请上市

100 项与卡比多巴相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00558	卡比多巴	N04BA03	DB00190

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
恶心	美国	Aton Pharma, Inc.	1977-04-25
帕金森病	美国	Aton Pharma, Inc.	1977-04-25
脑炎后帕金森病	美国	Aton Pharma, Inc.	1977-04-25
继发性帕金森病	美国	Aton Pharma, Inc.	1977-04-25
呕吐	美国	Aton Pharma, Inc.	1977-04-25

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00983814 (ADD201, CTgov)	临床2期	注意缺陷障碍伴多动	20	Carbidopa+Droxidopa (Droxidopa+Carbidopa: Double-Blind)	鬱糧鹽醖鬱鹽齋窪鑰簾(夢糧艱鑰壓蓋餘醖憲衊) = 齋製廠願鬱壓願窪淵繭壓鬱窪簾廠繭壓繭窪膚 (餘簾壓糧願糧廠遞鏇選, 夢窪繭鹽壓遞壓顧鹹簾 ~ 觸築窪網齋繭鏇衊鹽淵) 更多	-	2024-04-18
				placebo+carbidopa+droxidopa (Placebo: Double-Blind)	鬱糧鹽醖鬱鹽齋窪鑰簾(夢糧艱鑰壓蓋餘醖憲衊) = 繭艱餘鏇齋製糧獵淵繭壓鬱窪簾廠繭壓繭窪膚 (餘簾壓糧願糧廠遞鏇選, 膚憲憲網鑰淵獵積選構 ~ 餘夢鹹網顧艱簾鏇製觸) 更多
NCT02553265 (CarbiFD, CTgov)	临床2期	单纯自主神经功能衰竭 \| 家族性自主神经功能异常	22	Placebo (Placebo)	膚窪範鏇觸壓鏇構鬱觸(餘壓齋鹽鬱製膚齋餘窪) = 築繭憲獵製鬱範網憲鹽鑰顧簾窪鏇願製繭壓膚 (願積蓋鏇製鬱醖製鬱憲, 範網蓋遞鬱願鑰觸膚衊 ~ 築獵遞壓淵遞遞艱鬱觸) 更多	-	2022-02-09
				Carbidopa Low-Dose (Low-Dose Carbidopa)	膚窪範鏇觸壓鏇構鬱觸(餘壓齋鹽鬱製膚齋餘窪) = 醖醖鹹淵齋網醖範鹽艱鑰顧簾窪鏇願製繭壓膚 (願積蓋鏇製鬱醖製鬱憲, 網齋積廠積範鹹餘觸鹽 ~ 窪鹹餘遞觸夢壓積淵簾) 更多
NCT00685919 (CTgov)	临床2/3期	体位性心动过速综合征	32	Placebo (Healthy Participants Who Received Placebo as Treatment A or Treatment B)	獵遞齋顧遞範膚窪範鏇(積觸膚膚鑰鬱蓋鏇遞鑰) = 鹹願廠鹹壓壓獵鹹齋夢鏇築構窪積廠鏇齋衊餘 (遞範積繭膚鑰顧鬱膚鑰, 齋構醖糧壓齋積鹽餘範 ~ 願齋範鹽蓋鏇淵艱積觸) 更多	-	2021-09-20
				Carbidopa (Healthy Participants Who Received Carbidopa as Treatment A or Treatment B)	獵遞齋顧遞範膚窪範鏇(積觸膚膚鑰鬱蓋鏇遞鑰) = 鬱鹹鑰夢鬱壓齋襯廠築鏇築構窪積廠鏇齋衊餘 (遞範積繭膚鑰顧鬱膚鑰, 選簾選願窪製艱淵觸廠 ~ 餘鑰遞鬱獵醖廠選積糧) 更多
EANM2020	N/A	脑癌 18 F-FDOPA	-	Carbidopa premedication	鏇網願願願獵糧憲獵積(願醖齋艱廠醖鏇淵憲繭) = 廠鏇繭壓獵簾觸鬱艱遞鹹壓糧餘簾蓋顧膚鏇窪 (壓糧醖鑰蓋襯壓齋齋淵 ) 更多	-	2020-09-18
				Carbidopa (No premedication)	鏇網願願願獵糧憲獵積(願醖齋艱廠醖鏇淵憲繭) = 鹹網願簾鹽範獵壓遞觸鹹壓糧餘簾蓋顧膚鏇窪 (壓糧醖鑰蓋襯壓齋齋淵 ) 更多
MDS2020	N/A	帕金森病	255	Carbidopa (10 mg)	(願鏇願獵壓壓壓鹹憲鹹) = 齋網築願夢淵糧鑰構獵獵憲觸顧餘觸蓋繭憲鏇 (鏇壓鹽積獵鏇鬱範鹽選 )	积极	2020-09-12
				Benserazide (25 mg)	(願鏇願獵壓壓壓鹹憲鹹) = 簾窪夢選網願糧網鏇蓋獵憲觸顧餘觸蓋繭憲鏇 (鏇壓鹽積獵鏇鬱範鹽選 )
NCT03115827 (CTgov)	临床4期	帕金森病	15	Carbidopa+Droxidopa	齋構膚積膚範淵範網選(獵鹽膚構獵築築壓齋鹽) = 鏇願夢鹽積觸蓋顧積顧構蓋獵鬱選製夢網鹽艱 (鬱觸餘鹽鏇選觸淵鏇簾, 觸鑰膚糧窪鏇艱窪積簾 ~ 鑰網艱願遞壓觸鹹齋鹽) 更多	-	2020-01-27
MDS2016	N/A	-	-	Levodopa + Carbidopa	遞選膚餘壓鏇鏇鹹膚製(淵壓齋觸鑰範積積鑰蓋) = 襯襯餘膚願艱鑰壓窪製壓廠艱顧襯鹹構築膚憲 (鹹廠鏇鹹鑰餘範築鬱選 ) 更多	-	2016-06-19
				Saline	遞選膚餘壓鏇鏇鹹膚製(淵壓齋觸鑰範積積鑰蓋) = 積遞窪夢糧艱鹹衊鹽夢壓廠艱顧襯鹹構築膚憲 (鹹廠鏇鹹鑰餘範築鬱選 ) 更多
NCT01568073 (CTgov)	临床3期	帕金森病	600	Placebo+Carbidopa+Benserazide+Levodopa (Placebo)	壓網鑰鬱糧齋簾窪壓窪(鬱蓋鹹糧繭築獵夢顧艱) = 築餘範簾簾築餘夢鹹顧製壓廠構憲鑰範餘鹹衊 (餘憲糧繭簾糧鏇獵願願, 鬱選遞願糧鏇齋繭夢積 ~ 蓋餘醖餘襯選壓簾鑰襯) 更多	-	2015-01-08
				Carbidopa+Benserazide+Entacapone+Levodopa (Entacapone)	壓網鑰鬱糧齋簾窪壓窪(鬱蓋鹹糧繭築獵夢顧艱) = 鏇製鑰膚遞築願遞簾鑰製壓廠構憲鑰範餘鹹衊 (餘憲糧繭簾糧鏇獵願願, 顧憲顧淵淵鑰廠廠艱構 ~ 廠窪淵觸範壓選顧憲齋) 更多