CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 367 enrolled
Drug / intervention
Nuedexta (DM 20 mg/Q 10 mg)drug
Likely dose
Nuedexta (DM 20 mg/Q 10 mg)from 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/NCT01799941
NCT01799941Phase 4Completed
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A Study to Assess the Safety, Tolerability and Effectiveness of Nuedexta (Dextromethorphan 20 mg/Quinidine 10 mg) in the Treatment of Pseudobulbar Affect (PBA)

Avanir Pharmaceuticals·interventional·Posted Feb 27, 2013·Updated Mar 15, 2017

In Brief

A Phase 4 clinical trial evaluating Nuedexta (DM 20 mg/Q 10 mg) for Pseudobulbar Affect (PBA) and 3 related conditions. Completed, enrolled 367 participants across 1 site.

Detailed Summary

The objectives of the study are to evaluate the safety, tolerability, and effectiveness of NUEDEXTA capsules containing 20 mg DM (Dextromethorphan)/10 mg Q (Quinidine) for treatment of Pseudobulbar Affect (PBA) in patients with prevalent conditions such as dementia, stroke, and traumatic brain injury (TBI)over a 12 week period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPseudobulbar Affect (PBA), Stroke, Dementia, Traumatic Brain Injury (TBI)
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 27, 2013
Enrollment StartFeb 1, 2013
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.3 years ago

Interventions

Nuedexta (DM 20 mg/Q 10 mg)drug

Single Arm, Open-Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)