CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 209 enrolled
Drug / intervention
AVP-923-45 +3 moredrug
Likely dose
AVP-923-45 45 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01324232
NCT01324232Phase 2Completed
CompareCT.gov

A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients With Multiple Sclerosis

Avanir Pharmaceuticals·interventional·Posted Mar 28, 2011·Updated Nov 22, 2021

In Brief

A Phase 2 clinical trial evaluating AVP-923-45, AVP-923-30, and 2 other interventions for Central Neuropathic Pain and Multiple Sclerosis. Completed, enrolled 209 participants across 72 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCentral Neuropathic Pain, Multiple Sclerosis
CountriesArgentina, Czechia, Poland, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 28, 2011
Enrollment StartSep 8, 2011
Primary CompletionSep 26, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.3 years ago

Interventions

AVP-923-45drug

AVP-923-45 (dextromethorphan 45 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.

AVP-923-30drug

AVP-923-30 (dextromethorphan 30 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.

AVP-923-20drug

AVP-923-20 (dextromethorphan 20 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.

Placebodrug

Matching placebo capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.