Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2013 |
| End Date: | December 2015 |
A Study to Assess the Safety, Tolerability and Effectiveness of Nuedexta (Dextromethorphan 20 mg/Quinidine 10 mg) in the Treatment of Pseudobulbar Affect (PBA)
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.
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.
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.
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.
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
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