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NCT01799941 · ClinicalTrials.gov registry record · Phase 4
Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)
A Phase 4 study, sponsored by Avanir Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 367
- Enrollment target
NCT01799941: Completed Phase 4 study, sponsored by Avanir Pharmaceuticals.
NCT01799941 is a Phase 4 study that has completed, run by Avanir Pharmaceuticals. The registered enrollment target is 367 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01799941, a Phase 4 study, has completed, sponsored by Avanir Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 367 participants
- Enrollment target
Study 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.
Primary Outcome
The CNS-LS was a seven-item, self-administered questionnaire, completed by the participant or participant's caregiver that provided a quantitative measure of the perceived frequency and severity of Pseudobulbar Affect (PBA) episodes. It consisted of two subscales measuring labile laughter (four items) and labile crying (three items). Each item was rated on a scale from 1 (applies never) to 5 (applies most of the time). The total score was calculated as the sum of the item values that resulted in
Interventions
- DRUG Nuedexta (DM 20 mg/Q 10 mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 367 participants |
| Start Date | 2013-02 |
| Est. Completion | 2015-05 |
| Phase | Phase 4 |
What the finished NCT01799941 record still lists
NCT01799941 is an interventional study that assigns participants to a tested intervention. The registered 367 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 1 intervention - of which Nuedexta (DM 20 mg/Q 10 mg) is the first listed.
NCT01799941 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01799941 about?
NCT01799941 is a clinical study titled "Safety, Tolerability and Effectiveness of Nuedexta 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 Pseudobulbar Affect (PBA) in patients with prevalent conditions such as dementia, stroke, and traumatic brain injur...
What is the current status of trial NCT01799941?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 367 participants. The study started on 2013-02. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01799941?
The interventions under investigation include: Nuedexta (DM 20 mg/Q 10 mg) (DRUG).
Who is sponsoring clinical trial NCT01799941?
This trial is sponsored by Avanir Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01799941's enrollment target sits among peer trials
367 225th of 2000 higher than 1,776 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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