AVP-923-30 for Multiple Sclerosis (PRIME Trial)

Phase 2

Waitlist Available

Research Sponsored by Avanir Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; days 57 through 84 (prs score); days 22 and 50 (dextromethorphan plasma concentrations)

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 capsules in the treatment of central neuropathic pain in participants with multiple sclerosis.

Eligible Conditions

Multiple Sclerosis
Central Neuropathic Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; days 57 through 84 (prs score); days 22 and 50 (dextromethorphan plasma concentrations)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; days 57 through 84 (prs score); days 22 and 50 (dextromethorphan plasma concentrations)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; days 57 through 84 (prs score); days 22 and 50 (dextromethorphan plasma concentrations) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Association Between the Dextromethorphan Plasma Concentration and the Change From Baseline Pain Rating Scale (PRS) Score to the Average Pain Rating Scale Score During Days 57 Through 84

Average Logarithms of Dextromethorphan (DM) Plasma Concentrations (Cmax) on Days 22 and 50

Secondary study objectives

Comparison of the Adjusted Mean Change From Baseline PRS Score to the Average PRS Score During Days 57 Through 84

Mental Depression

Mean Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Days 22 and 85

+7 more

Other study objectives

Change From Baseline in Modified Ashworth Scale (MAS) Scores