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NCT00021697 · ClinicalTrials.gov registry record · Phase 3
Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS
A Phase 3 study of Amyotrophic Lateral Sclerosis, sponsored by Avanir Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 17
- Study locations
NCT00021697 is a Phase 3 study of Amyotrophic Lateral Sclerosis that has completed, run by Avanir Pharmaceuticals. The registered enrollment target is 100 participants, below the 897-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (89% lower). The trial reports 17 study locations across 12 states.
The verdict
NCT00021697, a Phase 3 study of Amyotrophic Lateral Sclerosis, has completed, sponsored by Avanir Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 17
- Study locations
Study Summary
The purpose of this study is to compare and evaluate the safety of AVP-923 (dextromethorphan/quinidine) for the treatment of emotional lability in ALS patients.
Conditions Studied
Interventions
- DRUG AVP-923
Study Locations (17)
California
- Loma Linda University Dept. of Neurology - Loma Linda
- UCLA School of Medicine Dept. of Neurology - Los Angeles
- University of California, San Francisco - San Francisco
New York
- Columbia-Presbyterian Center Neurological Institute - New York
- State University of New York - Syracuse
North Carolina
- Carolinas Medical Center Carolinas Neuromuscular/ALS-MDA Center - Charlotte
- Wake Forest University - Winston-Salem
Pennsylvania
- MCP-Hahnemann University Dept. of Neurology - Philadelphia
- Penn Neurological Institute - Philadelphia
Colorado
- University of Colorado Health Sciences - Denver
Florida
- University of Miami Dept. of Neurology - Miami
Illinois
- Northwestern Medical School - Chicago
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2001-01 |
| Est. Completion | 2002-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00021697
The ClinicalTrials.gov registry entry for NCT00021697 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 897-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (89% lower). The listed sponsor is Avanir Pharmaceuticals, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which AVP-923 is the first listed.
NCT00021697 reports 17 study locations spanning 12 distinct geographic areas - top geographies include California, New York, North Carolina.
Frequently Asked Questions
What is clinical trial NCT00021697 about?
NCT00021697 is a clinical study titled "Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS". The purpose of this study is to compare and evaluate the safety of AVP-923 (dextromethorphan/quinidine) for the treatment of emotional lability in ALS patients.
What is the current status of trial NCT00021697?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2001-01. Estimated completion is 2002-04.
What conditions does trial NCT00021697 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis.
What interventions are being tested in trial NCT00021697?
The interventions under investigation include: AVP-923 (DRUG).
Who is sponsoring clinical trial NCT00021697?
This trial is sponsored by Avanir Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00021697 being conducted?
This trial has 17 study locations across California, Colorado, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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