Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Relapsing Forms of Multiple Sclerosis
NCT04909502 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2022-10-21
Summary
The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in adult subjects with Relapsing Forms of Multiple Sclerosis (RMS).
Conditions
- Relapsing Forms of Multiple Sclerosis
Interventions
- DRUG
-
EHP-101 25 mg OD
25 mg OD during the first 28 Days of the trial
- DRUG
-
EHP-101 25 mg BID
25 mg BID during the first 28 Days of the trial
- DRUG
-
EHP-101 50 mg OD
After 28 Days of treatment with 25 mg OD, patients will escalate to 50 mg OD up to the end of the trial
- DRUG
-
EHP-101 50 mg BID
After 28 Days of treatment with 25 mg BID, patients will escalate to 50 mg BID up to the end of the trial
Sponsors & Collaborators
-
Emerald Health Pharmaceuticals
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-19
- Primary Completion
- 2023-12-31
- Completion
- 2024-04-30
- FDA Drug
- Yes
Countries
- United States
- Australia
Study Locations
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