This is a multi-center, randomized, double-blind, placebo-controlled, dose-response study of MLC1501 in patients with stroke. Eligible participants will be randomized in a 1:1:1 ratio to orally receive MLC1501 low-dose twice a day, MLC1501 high-dose twice a day, or matching placebo for 24 weeks.

开始日期2025-01-01

申办/合作机构

Moleac Pte Ltd.

NCT06228638 / RecruitingN/A

CognivAiD Real-World Evidence Clinical Registry

This is an observational, prospective cohort of patients who were prescribed or have taken CognivAiD as prescribed by the attending physician. The safety and efficacy of CognivAiD have been established in clinical studies. The registry will assess the safe use and effectiveness of CognivAiD in a real-world setting. The registry is designed as a product registry in clinical practice. The design also takes into account the different scenarios of product use in the real world (e.g., switching therapies during follow-up, use of multiple products in combination or sequence, different dosing, and compliance).

开始日期2023-12-12

申办/合作机构

Moleac Pte Ltd.

NCT05289947 / Recruiting临床2期

A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of MLC1501 in Patients With Stroke

This is a multi-center, randomized, double-blind, placebo-controlled trial of MLC1501 in patients with stroke. Eligible participants will be randomized in a 1:1:1 ratio to orally receive MLC1501 high-dose twice a day, MLC1501 low-dose twice a day, or matching placebo for 24 weeks.

开始日期2023-07-21

申办/合作机构

Moleac Pte Ltd.

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项与 Moleac Pte Ltd. 相关的文献（医药）

2015-02-01·International journal of stroke : official journal of the International Stroke Society

Using the Full Span of the SPAN-100 Index to Predict Functional Outcome in the CHIMES Study

Letter

作者: De Silva, Deidre Anne ; Lee, Chun Fan ; Fabiaña, Natasha L. ; Gan, Robert ; Venketasubramanian, Narayanaswamy ; Chen, Christopher P. L. H. ; Bousser, Marie-Germaine ; Wong, K. S. Lawrence

2009-02-01·International journal of stroke : official journal of the International Stroke Society2区 · 医学

A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Investigate Chinese Medicine Neuroaid Efficacy on Stroke Recovery (CHIMES Study)

2区 · 医学

Article

作者: Bousser, M. G. ; Tan, S. B. ; Donnan, G. A. ; Venketasubramanian, N. ; Chan, B. P. L. ; Picard, D. ; Chang, H. M. ; Poungvarin, N. ; Chen, C. L. H. ; Navarro, J. C. ; Gan, R. N. ; Baroque, A. C.

Rationale:

Traditional Chinese Medications (TCM) have been reported to have beneficial effects in stroke patients, but were not rigorously evaluated by GCP standards.

Aim:

This study tests the hypothesis that Neuroaid, a TCM widely used in China post-stroke, is superior to placebo in reducing neurological deficit and improving functional outcome in patients with acute cerebral infarction of an intermediate severity.

Design:

This is a multicenter, randomised, double-blind, placebo-controlled study of Neuroaid in ischemic stroke patients with National Institute of Health Stroke Scale (NIHSS) 6–14 treated within 48 h of stroke onset. Neuroaid or placebo is taken (4 capsules) 3 times daily for 3 months. Treatments are assigned using block randomization, stratified for centers, via a central web-randomization system. With a power of 90% and two-sided test of 5% type I error, a sample size is 874. Allowing for a drop-out rate of up to 20%, 1100 individuals should be enrolled in this study.

Study Outcomes:

The primary efficacy endpoint is the modified Rankin Scale (mRS) grades at 3 months. Secondary efficacy endpoints are the NIHSS score at 3 months; difference of NIHSS scores between baseline and 10 days, and between baseline and 3 months; difference of NIHSS sub-scores between baseline and 10 days, and between baseline and 3 months; mRS at 10 days, 1 month, and 3 months; Barthel index at 3 months; Mini Mental State Examination at 10 days and 3 months. Safety outcomes include complete blood count, renal and liver panels, and electrocardiogram. Study registration: ClinicalTrials.gov identifier: NCT00554723.

项与 Moleac Pte Ltd. 相关的新闻（医药）

2024-10-21

·PRNewswire

Moleac Announces PT Ferron Par Pharmaceuticals as New Exclusive Partner in Indonesia

SINGAPORE, Oct. 21, 2024 /PRNewswire/ -- Moleac is excited to announce a significant milestone in the journey of NeuroAiD II MLC901 as PT Ferron Par Pharmaceuticals will become our exclusive partner in Indonesia effective Jan 1st 2025. We are immensely grateful for the fruitful 12-year partnership with PT Mersifarma Tirmaku Mercusana, and we sincerely thank them for their invaluable contributions to our success in Indonesia. As we embark on a new chapter, we are thrilled to welcome PT Ferron Par Pharmaceuticals — a member of Dexa Group — as our new exclusive commercial partner. This partnership marks a crucial milestone in our mission to widen access to our groundbreaking products, supporting healthcare professionals in enhancing outcomes for patients recovering from stroke, traumatic brain injuries, and neurodegenerative diseases. With PT Ferron Par Pharmaceuticals, a leader renowned for its market expertise and operational excellence, we are confident in our accelerated growth and the expanded availability of NeuroAiD II MLC901 to those in need. We look forward to a future of growth and continued innovation as we extend the reach of NeuroAiD II MLC901 in Indonesia to benefit more patients. About Moleac Moleac is a biopharmaceutical company that stays committed to helping patients and their families reconnect with their lives. We address unmet needs of patients suffering a loss of brain function after brain injuries or neurodegenerative diseases. Our focus is to help them regain and maintain independence. We select scientifically proven natural compounds and formulations with origins in traditional medicine, establish their clinical properties, and make them available internationally. For further information, visit moleac.com. About PT Ferron Par Pharmaceuticals PT Ferron Par Pharmaceuticals, a member of Dexa Group, is a fast growing pharmaceutical company that started its operation in 2001. Ferron has become one of the 20 largest pharmaceutical operations in Indonesia (Combined IHPA+IPA 2005, IMS Audit). With a diverse product portfolio, advanced manufacturing capabilities, and strong partnerships, Ferron continues to strengthen its market presence and operational excellence. For more information, visit dexagroup.com. SOURCE Moleac WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

引进/卖出

2022-06-06

·PRNewswire

NeuroAiD has shown favourable outcome in patients suffering from spinal cord injuries

SATURN study aimed at assessing the safety and effects of a 6-month course of NeuroAiD (MLC601/MLC901) to augment functional and motor recovery after severe spinal cord injury (SCI). NeuroAiD was safe as add-on treatment in patients with severe SCI. One third of patients improved on ASIA Impairment Scale (AIS) grading with corresponding motor recovery at month 6. SINGAPORE, June 6, 2022 /PRNewswire/ -- Moleac is pleased to announce the release of the results of the SATURN study1 published online in the Journal of Spinal Cord Medicine . Spinal cord injury (SCI) carries debilitating consequences with severe neurological and functional deficits, deteriorating the quality of life for survivors and their relatives. To date, there is no way to reverse spinal cord damage, and new treatments are always sought, including prostheses, devices and medications, to improve motor function and function recovery in SCI. NeuroAiD has well established neuroprotective and neurorepair properties that enhance neurological recovery on top of rehabilitation in stroke and traumatic brain injury. It could represent a new therapeutic approach for SCI patients. SATURN (Spinal cord injury Assessing Tolerability and Use of combined Rehabilitation and NeuroAiD) study was designed to evaluate the safety and potential role of NeuroAiD in subjects suffering from severe SCI. This pilot study included 30 subjects with American Spinal Injury Association (ASIA) Impairment Scale (AIS) grades A and B, who received a 6-month course of NeuroAiD on top of standard care and rehabilitation. The key endpoints were the safety profile by measuring the occurrence of adverse events (AEs) during the 6-month course of NeuroAiD and the improvements in the AIS grade and motor score at month 6. Key findings: A total of 14 AEs were reported by 10 patients, none being deemed definitely, likely or possibly related to NeuroAiD. 33% of patients improved their AIS score at month 6 from baseline, with improvement in 25% and 50% of patients in the AIS A and AIS B groups, respectively. One patient has even achieved complete recovery (grade E). The Asia total motor score improved over time from 17.1 at baseline to 49.9 at month 6. Of note, the investigators pointed out that the improvement rates during the 6-month course of NeuroAiD appear to be higher than the previously reported spontaneous recovery rates of approximately 10% from grade A to grade B and 10 % at grade C, 80% of patients remaining at grade A. "Any improvement in AIS grading is clinically important for SCI patients," said Prof. Ramesh Kumar, neurosurgeon at Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur. "The rates of improvement we saw at 6 months in our study with NeuroAiD in this severe SCI sample with excellent safety, are very encouraging to use and to develop it as a complementary therapeutic option." NeuroAiD shows a favourable safety profile and promising benefits as an add-on therapy to patients suffering from severe spinal cord injuries. ACCESS THE ARTICLE HERE About NeuroAiD NeuroAiD is a 9 component-herbal supplements that is carries the neuroprotective and neurorestorative properties. Multiple clinical studies were conducted in NeuroAiD showing efficacy in stroke, and patients with traumatic brain injuries. About Moleac Moleac is a biopharmaceutical company committed to helping patients and their families reconnect with their lives. We address unmet needs of patients suffering from a loss of brain functions after a brain injury or neurodegenerative diseases. Our focus is to help them regain and maintain independence. We select scientifically proven natural compounds and formulations with origins in traditional medicine, establish their clinical properties, and make them available internationally. NeuroAiDTM and NurAiDTM are trademarks of Moleac. MLC601 (NeuroAiDTM) and MLC901 (NeuroAiDTMII/NurAiDTMII) are two different proprietary formulae which have been shown to be equivalent in pharmacology and are referred as "NeuroAiD" in this document. Ramesh Kumar et al. Spinal cord injury – assessing tolerability and use of combined rehabilitation and NeuroAiD (SATURN) study – primary results of an exploratory study. The Journal of Spinal Cord Medicine. May 2022, DOI: 10.1080/10790268.2022.2067972. For more information, contact [email protected] SOURCE Moleac

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