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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 is a Phase 4 study that has completed, run by Avanir Pharmaceuticals. The registered enrollment target is 367 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01799941
The ClinicalTrials.gov registry entry for NCT01799941 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 367 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Avanir Pharmaceuticals, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nuedexta (DM 20 mg/Q 10 mg) is the first listed.
NCT01799941 reports 0 study locations.
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.
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