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Clinical Trial: EHP-101-MS02

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Details
Type of MS: RRMS|SPMS
Treatment mode of action: Immunomodulation, neuroprotection, potential remyelination
Number of Subjects: 50
Medication: an oral formulation of a patented new chemical entity derived from cannabidiol
Location: California
Institutions: Please see below Contact Information
Amanda Hughes
(858) 832-4887
ahughes@emeraldpharma.com

Funding:

Emerald Health Pharmaceuticals

Description

Brief Description
The purpose of this study is to evaluate a new potential treatment for people living with Relapsing Forms of Multiple Sclerosis (RMS). Following the completion of a Phase 1 human clinical trial that assessed the safety and tolerability of different daily doses of the investigational new drug, EHP-101, in healthy volunteers, this Phase 2a clinical trial is focused on evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in people living with RMS.  
 
Brief Treatment Description
This is an open-label study design without the use of a placebo. The study will initially be conducted with 2 treatment arms starting in parallel. Initially, study participants will receive a 25 mg once a day or a 25 mg twice a day dose of the investigational new drug, EHP-101. After 28 days, each study participant will increase to a 50 mg once a day or 50 mg twice a day dose level, respectively, for an additional 5-month treatment, if deemed to be safe by the Investigator or study doctor. 
 
Study Involvement
The overall study participation is about 8 months. It will include a screening period of up to 28 days and study participants will be followed-up for another 28 days after the last investigational new drug administration. The treatment period, which is when the investigational new drug, EHP-101, will be administered, will be for about 6 months or 168 days.    
 
Please visit https://clinicaltrials.gov/ct2/show/NCT04909502 for more information about the study.     
 

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