Status:
COMPLETED
Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)
Lead Sponsor:
Avanir Pharmaceuticals
Conditions:
Pseudobulbar Affect (PBA)
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 Af...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- Unstable neurologic disease
- Severe dementia
- Stroke within 3 months
- Penetrating TBI
- Contraindications to Nuedexta
- Severe Depressive Disorder
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
367 Patients enrolled
Trial Details
Trial ID
NCT01799941
Start Date
February 1 2013
End Date
May 1 2015
Last Update
March 15 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pensacola, Florida, United States, 32503