This trial is active, not recruiting.

Conditions pseudobulbar affect (pba), stroke, dementia, traumatic brain injury (tbi)
Treatment nuedexta (dm 20 mg/q 10 mg)
Phase phase 4
Sponsor Avanir Pharmaceuticals
Collaborator OptumInsight Life Sciences
Start date February 2013
End date June 2015
Trial size 750 participants
Trial identifier NCT01799941, 12-AVR-401


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 PBA in patients with prevalent conditions such as dementia, stroke and traumatic brain injury over a 12 week period.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Single Arm, Open Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)
nuedexta (dm 20 mg/q 10 mg) Nuedexta
Single Arm, Open-Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)

Primary Outcomes

The primary efficacy endpoint is the mean change from baseline at 12 weeks in CNS-LS score.
time frame: 12 weeks

Secondary Outcomes

Safety and Tolerability
time frame: 12 weeks
PBA Episode Counts
time frame: 12 weeks
Patient Global Impression-Change (PGI-C)
time frame: 12 Weeks
Clinical Global Impression-Change (CGI-C)
time frame: 12 Weeks
Patient Satisfaction with Treatment Survey
time frame: 12 Weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Center for Neurologic Study-Lability Scale (CNS-LS)score of 13 or greater - Clinical diagnosis of Pseudobulbar Affect (PBA) - Documentation of Neurologic disease or brain injury Exclusion Criteria: - Unstable neurologic disease - Severe dementia - Stroke within 3 months - Penetrating TBI - Contraindications to Nuedexta - Severe Depressive Disorder

Additional Information

Official title A Study to Assess the Safety, Tolerability and Effectiveness of Nuedexta (Dextromethorphan 20 mg/Quinidine 10 mg) in the Treatment of Pseudobulbar Affect (PBA)
Description This will be an Open-label, Multicenter, study in patients with PBA and dementia, stroke or TBI. Patients with a clinical diagnosis of PBA and who meet all other inclusion and exclusion criteria will be eligible to participate and receive NUEDEXTA for 12 weeks. Males and females patients with a minimum age of 18 years, a clinical diagnosis of Pseudobulbar Affect and a documented diagnosis of neurologic disease or brain injury, will be enrolled in this study. The primary effectiveness endpoint is the mean change in the CNS Lability scale (CNS-LS). Secondary objectives include measures to evaluate treatment outcomes.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Avanir Pharmaceuticals.