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NCT00573443 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS
A Phase 3 study, sponsored by Avanir Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 326
- Enrollment target
NCT00573443 is a Phase 3 study that has completed, run by Avanir Pharmaceuticals. The registered enrollment target is 326 participants.
The verdict
NCT00573443, a Phase 3 study, has completed, sponsored by Avanir Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 326 participants
- Enrollment target
Study Summary
Objectives of the study are to evaluate the safety, tolerability, and efficacy of two different doses of AVP-923 (capsules containing either 30 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate \[AVP-923-30\] or 20 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate \[AVP-923-20\]) when compared to placebo, for the treatment of PBA in a population of patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS) over a 12-week period. An additional objective is to determine the pharmacokinetic parameters of the two different doses of AVP-923 in a subset of the study population. Pseudobulbar Affect (PBA) is a condition characterized by involuntary, sudden and frequent episodes of laughing and/or crying out of proportion or incongruous to the underlying emotion of happiness or sadness Other terms used to describe this condition include emotional lability, emotionalism, emotional incontinence, emotional discontrol, excessive emotionalism, and pathological laughing and crying. The outbursts can occur spontaneously or in response to provocative stimuli such as questions or events. A body of evidence suggests that PBA can be modulated through pharmacologic intervention. Dextromethorphan (DM) is a low-affinity uncompetitive antagonist of the N-Methyl-D-aspartate (NMDA) receptor, reducing the level of excitatory activity. DM also acts at the phencyclidine-binding site, which is part of the NMDA receptor complex. DM is a sigma receptor agonist, suppressing the release of excitatory neurotransmitters. Quinidine (Q) is a known potent inhibitor of cytochrome P450 2D6 (CYP2D6), that decreases the metabolism of dextromethorphan and helps to achieve sustained and therapeutic levels of this drug.
Interventions
- DRUG Placebo
- DRUG dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg
- DRUG dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2007-12 |
| Est. Completion | 2009-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00573443
The ClinicalTrials.gov registry entry for NCT00573443 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 326 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 3 interventions - of which Placebo is the first listed.
NCT00573443 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00573443 about?
NCT00573443 is a clinical study titled "Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS". Objectives of the study are to evaluate the safety, tolerability, and efficacy of two different doses of AVP-923 (capsules containing either 30 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate \[AVP-923-30\] or 20 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate \...
What is the current status of trial NCT00573443?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 326 participants. The study started on 2007-12. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00573443?
The interventions under investigation include: Placebo (DRUG), dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg (DRUG), dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg (DRUG).
Who is sponsoring clinical trial NCT00573443?
This trial is sponsored by Avanir Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
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