At a glance
ClinicalIndex Comparison RecordPhase 3Completed
Drug / intervention
AVP-923drug
Likely dose
Not stated in 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.
A Double-Blind Controlled, Multicenter Phase II/III Study to Assess the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect in Patients With Amyotrophic Lateral Sclerosis
In Brief
A Phase 3 clinical trial evaluating AVP-923 for Amyotrophic Lateral Sclerosis. Completed, across 17 sites.
Detailed Summary
The purpose of this study is to compare and evaluate the safety of AVP-923 (dextromethorphan/quinidine) for the treatment of emotional lability in ALS patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2001
First PostedAug 2001
Primary CompletionApr 2002
TodayJul 2026
First PostedAug 3, 2001
Enrollment StartJan 1, 2001
Primary CompletionApr 1, 2002
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 24.9 years ago
Interventions
AVP-923drug