A Randomized, Double-Blind, 6-Way Crossover Study to Determine the Abuse Potential of Tozadenant Relative to D-Amphetamine and Placebo When Administered Orally in Healthy, Non-Dependent, Recreational Polydrug Users With Stimulant Experience, Under Fed Conditions

This will be a single-dose, randomized, double-blind, active- and placebo-controlled, double dummy, 6-way crossover study to determine the abuse potential of tozadenant relative to d-amphetamine and placebo, when administered orally in healthy non-dependent, recreational polydrug users with stimulant experience, under fed conditions.
Each subject will participate in a medical Screening visit, a 4-day (3-night) qualification (drug discrimination) visit, six 3-day (2-night) treatment periods, and a follow-up visit.

开始日期2017-09-18

申办/合作机构

Biotie Therapies Oy

[+1]

NCT03212313 / Terminated临床1期

A Two-Part, Open-Label, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Tozadenant

This is a two-part, open label, single-dose study that will evaluate the PK of tozadenant in subjects with different degrees of hepatic impairment to the PK of a single-dose of tozadenant in healthy subjects.

开始日期2017-06-30

申办/合作机构

Biotie Therapies Oy

[+1]

NCT03051607 / Terminated临床3期

A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose "Wearing-Off"

Phase 3, international, multicenter, open-label 12 month safety study.

开始日期2017-04-10

申办/合作机构

Biotie Therapies Oy

[+1]

100 项与 Tozadenant 相关的临床结果

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100 项与 Tozadenant 相关的转化医学

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100 项与 Tozadenant 相关的专利（医药）

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项与 Tozadenant 相关的文献（医药）

2023-06-01·The Journal of pediatrics

Adverse Effects of α-2 Adrenergic Agonists and Stimulants in Preschool-age Attention-deficit/Hyperactivity Disorder: A Developmental–Behavioral Pediatrics Research Network Study

Article

作者: Loe, Irene M ; Friedman, Sandra ; Barbaresi, William ; Vanderbilt, Douglas ; Shults, Justine ; Cacia, Jaclyn ; Mittal, Shruti ; Deavenport-Saman, Alexis ; Blum, Nathan J ; LaRosa, Angela ; Bax, Ami ; Harstad, Elizabeth

OBJECTIVES:

To characterize and compare the type and frequency of a range of common and uncommon adverse effects (AEs) associated with α-2 adrenergic agonist (A2A) and stimulant treatment of attention-deficit/hyperactivity disorder at preschool-age as well as to evaluate the impact of age on common AEs.

STUDY DESIGN:

This was a retrospective electronic medical record review of children <72 months of age (n = 497) evaluated at outpatient developmental-behavioral pediatric practices at 7 US academic medical centers within the Developmental-Behavioral Pediatrics Research Network. Data on AEs were abstracted for children who had treatment initiated by a developmental-behavioral pediatrician with an A2A or stimulant medication between January 2013 and July 2017; follow-up was complete by February 2019.

RESULTS:

A2A and stimulants had distinctive AE profiles. A2A compared with stimulants had a greater proportion with daytime sleepiness and headaches; stimulants had significantly greater proportions for most other AE, including moodiness/irritability, difficulty with sleep, appetite suppression, stomachaches, skin picking/repetitive behaviors, withdrawn behavior, and weight loss. Younger age was associated with disruptive behavior and difficulty with sleep.

CONCLUSIONS:

Stimulants had a greater rate of most AEs compared with A2A. AE profiles, together with efficacy, should inform clinical decision-making. Prospective randomized clinical trials are needed to fully compare efficacy and AE profiles of A2A and stimulants.

2022-09-01·The Science of the total environment2区 · 环境科学与生态学

Climate change simulation and trend analysis of extreme precipitation and floods in the mesoscale Rur catchment in western Germany until 2099 using Statistical Downscaling Model (SDSM) and the Soil & Water Assessment Tool (SWAT model)

2区 · 环境科学与生态学

Article

作者: Korres, Wolfgang ; Eingrüber, Nils

Due to climate change and global warming, speed and intensity of the hydrological cycle will accelerate. In order to carry out regional risk assessment, integrated water resources management and flood protection, far reaching predictions and future scenarios of climate change effects on extreme precipitation and flooding are of particular relevance. In this study, trends in frequencies of extreme precipitation and floods until 2099 are analysed for the German Rur catchment, which is half located in highlands and half in lowlands and therefore has a high topographical and climatological contrast. To predict future trends, coupled modeling is performed based on NCEP reanalysis data and a General Circulation Model (GCM). Assuming HadCM3 future emission scenarios A2a and B2a, an empirical Statistical Downscaling Model (SDSM) is developed and daily precipitation amounts are projected until 2099 by a stochastic weather generator. The generated precipitation data are used as an input for the ecohydrological Soil & Water Assessment Tool (SWAT model) to simulate daily water discharge until 2099. Statistical trend analyses are implemented based on three annual extreme precipitation indices (EPIs) and the magnitudes of ten flood return periods derived with GEV and Gumbel extreme value distributions for 109 30-year moving periods using regression analyses and Mann-Kendall tendency tests to check for significant trends in the frequencies until 2099. As a result, it could be demonstrated for all EPIs that the frequency of extreme precipitation in the upper Rur catchment will significantly increase by +33% to +51% until 2099 compared to the base period 1961-1990, whereas mostly non-significant negative trends of extreme precipitation can be projected in the lowlands. For runoff, it was found that the magnitudes of the ten flood return periods will significantly increase by +31% for B2a to +36% for A2a until 2099 compared to the base period.

2022-08-01·Journal of child and adolescent psychopharmacology

Association of Coexisting Conditions, Attention-Deficit/Hyperactivity Disorder Medication Choice, and Likelihood of Improvement in Preschool-Age Children: A Developmental Behavioral Pediatrics Research Network Study

Article

作者: Deavenport-Saman, Alexis ; Barbaresi, William ; Friedman, Sandra ; Shults, Justine ; Cacia, Jaclyn ; Mittal, Shruti ; Loe, Irene ; LaRosa, Angela ; Vanderbilt, Douglas L. ; Harstad, Elizabeth ; Blum, Nathan ; Bax, Ami

Objectives: To determine whether conditions coexisting with attention-deficit/hyperactivity disorder (ADHD) in preschool-age children are associated with choice of stimulants or alpha-2 adrenergic agonists (A2As) and/or likelihood of improvement in ADHD symptoms. Methods: A retrospective electronic health record review of 497 children from 7 Developmental Behavioral Pediatrics Research Network (DBPNet) sites. Children were <72 months when treated with medication for ADHD from January 1, 2013 to July 1, 2017. We abstracted coexisting conditions, initial medication prescribed, and whether the medication was associated with improvement in symptoms. Analysis of improvement was adjusted for clustering by clinician and site. Results: The median (interquartile range) child age at the time of initiation of ADHD medication was 62 (54-67) months. The most common coexisting conditions included language disorders (40%), sleep disorders (28%), disruptive behavior disorders (22.7%), autism spectrum disorder (ASD; 21.8%), and motor disorders (19.9%). No coexisting conditions were present in 17.1%; 1 in 36.8%, 2 in 26.8%, and ≥3 in 19.3%. Stimulants were initially prescribed for 322 (64.8%) and A2A for 175 (35.2%) children. Children prescribed stimulants were more likely to have no coexisting conditions than those prescribed A2A (22.3% vs. 7.4%; p < 0.001). Coexisting ASD and sleep disorder were associated with increased likelihood of starting A2As versus stimulants (p < 0.0005; p = 0.002). The association between medication treatment and improvement varied by number of coexisting conditions for 0, 1, 2, or ≥3, respectively (84.7%, 73.8%, 72.9%, 64.6%; p = 0.031). Children with ≥3 coexisting conditions were less likely to respond to stimulants than children with no coexisting conditions (67.4% vs. 79.9%; p = 0.037). Conclusions: Among preschool-age children with ADHD, those with ≥3 coexisting conditions were less likely to respond to stimulants than those with no coexisting conditions. This was not found for A2A, but further research is needed as very few children with no coexisting conditions were treated with A2A.

项与 Tozadenant 相关的新闻（医药）

2017-12-09

·BioPortfolio

Biotie Therapies Corp Pharmaceuticals Healthcare Deals and Alliances Profile [Report Updated: 27112017] Prices from USD $250

Summary Biotie Therapies Corp Biotie is a pharmaceutical company that discovers and develops new medicines for the treatment of various diseases. The company offers products for use in the treatment of neurodegenerative and psychiatric disorders such as parkinson's disease, alzheimer's disease, primary sclerosing cholangitis and other cognitive disorders; and inflammatory and fibrotic diseases. Its products under clinical development include Selincro, an opioid receptor ligand; Tozadenant, an innovative A2a antagonist; SYN120, a selective 5HT6 receptor antagonist; and BTT1023, a monoclonal antibody, among others. The company has presence in Finland and the US. Biotie is headquartered in Turku, Finland. Biotie Therapies Corp Pharmaceuticals Healthcare Deals and Alliances Profile provides you comprehensive data and trend analysis of the company's Mergers and Acquisitions MAs, partnerships and financings. The report provides detailed information on Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnership transactions recorded by the company over a five year period. The report offers detailed comparative data on the number of deals and their value categorized into deal types, subsector and regions. GlobalData derived the data presented in this report from proprietary inhouse Pharma eTrack deals database, and primary and secondary research. Scope Financial Deals Analysis of the company's financial deals including Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnerships. Deals by Year Chart and table displaying information encompassing the number of deals and value reported by the company by year, for a five year period. Deals by Type Chart and table depicting information including the number of deals and value reported by the company by type such as Mergers and Acquisitions, Equity/Debt Offering etc. Deals by Region Chart and table presenting information on the number of deals and value reported by the company by region, which includes North America, Europe, Asia Pacific, the Middle East and Africa and South and Central America. Deals by Subsector Chart and table showing information on the number of deals and value reported by the company, by subsector. Major Deals Information on the company's major financial deals. Each such deal has a brief summary, deal type, deal rationale; and deal financials and target Company's major public companies key financial metrics and ratios. Business Description A brief description of the company's operations. Key Employees A list of the key executives of the company. Important Locations and Subsidiaries A list and contact details of key centers of operation and subsidiaries of the company. Key Competitors A list of the key competitors of the company. Key Recent Developments A brief on recent news about the company. Reasons to Buy Get detailed information on the company's financial deals that enable you to understand the company's expansion/divestiture and fund requirements The profile enables you to analyze the company's financial deals by region, by year, by business segments and by type, for a five year period. Understand the company's business segments' expansion / divestiture strategy The profile presents deals from the company's core business segments' perspective to help you understand its corporate strategy. Access elaborate information on the company's recent financial deals that enable you to understand the key deals which have shaped the company Detailed information on major recent deals includes a summary of each deal, deal type, deal rationale, deal financials and Target Company's key financial metrics and ratios. Equip yourself with detailed information about the company's operations to identify potential customers and suppliers. The profile analyzes the company's business structure, locations and subsidiaries, key executives and key competitors. Stay uptodate on the major developments affecting the company Recent developments concerning the company presented in the profile help you track important events. Gain key insights into the company for academic or business research Key elements such as break up of deals into categories and information on detailed major deals are incorporated into the profile to assist your academic or business research needs. Note*: Some sections may be missing if data is unavailable for the company.

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100 项与 Tozadenant 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10174	Tozadenant	-	DB12203

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
帕金森病	临床3期	奥地利	Biotie Therapies Oy	2015-07-01
帕金森病	临床3期	捷克	Biotie Therapies Oy	2015-07-01
帕金森病	临床3期	德国	Biotie Therapies Oy	2015-07-01
帕金森病	临床3期	意大利	Biotie Therapies Oy	2015-07-01
帕金森病	临床3期	西班牙	Biotie Therapies Oy	2015-07-01

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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


NCT03051607 (CTgov)	临床3期	帕金森病	66	Tozadenant	鑰齋衊構鹹夢網醖鹽遞(襯蓋獵遞襯衊糧衊選鹹) = 獵廠蓋鬱衊壓選醖鏇襯遞鹽襯鏇憲淵餘積顧鹹 (鏇獵憲襯鏇憲積選簾選, 顧窪廠淵壓範觸積壓襯 ~ 糧壓積衊簾鏇築淵窪廠) 更多	-	2019-05-03
NCT02453386 (TOZ-PD, CTgov)	临床3期	帕金森病	449	placebo (Placebo BID)	夢壓齋鹹淵鹽壓膚鏇願(鹽鑰築餘遞衊簾繭壓壓) = 築廠衊鏇構觸衊蓋糧夢蓋願遞鏇網遞製廠憲齋 (遞淵鹽遞餘鏇鬱積觸鹽, 鬱鑰鹹鑰壓積襯願夢獵 ~ 願廠鹽繭鹽鬱簾糧鏇鬱) 更多	-	2019-03-26
NCT02453386 (TOZ-PD, CTgov)	临床3期	帕金森病	449	tozadenant (Tozadenant 60 mg BID)	夢壓齋鹹淵鹽壓膚鏇願(鹽鑰築餘遞衊簾繭壓壓) = 艱廠糧齋夢選鑰網鹽醖蓋願遞鏇網遞製廠憲齋 (遞淵鹽遞餘鏇鬱積觸鹽, 醖齋憲願廠艱鏇艱衊鹽 ~ 積築夢衊廠遞網蓋網衊) 更多	-	2019-03-26
MDS2017	临床3期	直立性低血压	-	TOZ 30 mg/kg	鏇繭窪夢艱築齋膚鑰衊(簾願範鹽顧廠簾觸夢糧) = 積餘鑰醖齋襯憲獵築膚獵糧繭構製齋鹽襯觸範 (築網艱積蓋積蓋糧廠範 )	-	2017-06-04
tozadenant study (MDS2017)	N/A	帕金森病	247	Tozadenant 60 mg	遞顧觸簾蓋憲憲醖襯鬱(顧鹽窪鏇繭鹽蓋鏇選願) = 觸蓋網鬱繭繭觸壓築壓窪簾觸顧繭鑰遞壓衊夢 (淵築選窪製選鹽壓憲餘 )	积极	2017-06-04
tozadenant study (MDS2017)	N/A	帕金森病	247	Tozadenant 120 mg	遞顧觸簾蓋憲憲醖襯鬱(顧鹽窪鏇繭鹽蓋鏇選願) = 選獵齋積繭膚憲壓網鏇窪簾觸顧繭鑰遞壓衊夢 (淵築選窪製選鹽壓憲餘 )	积极	2017-06-04