NCT04909502

Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Relapsing Forms of Multiple Sclerosis

A Phase IIa, Open-label, Multicentre Dose-Finding Trial in Patients With Relapsing Forms of Multiple Sclerosis (RMS) to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Emerald Health Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Detailed description

An interventional, open label, randomized design will be used to test safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in 50 patients ≥ 18 and ≤ 55 years of age with documented RMS. There will be a screening period of up to 28 days, 168 days treatment period, and 28 days follow-up.

Conditions

• Relapsing Forms of Multiple Sclerosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-10-19
• Primary completion: 2023-12-01
• Completion: 2024-04-01
• First posted: 2021-06-01
• Last updated: 2022-10-21

Locations

4 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study