Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Amyotrophic Lateral Sclerosis, sponsored by Avanir Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00021697 record still lists
NCT00021697 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 897-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (89% lower).
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 lists 17 locations in 12 states (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.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00021697's enrollment target sits among peer trials
100 39th of 102 higher than 62 of 102 other Amyotrophic Lateral Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis 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
-
Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients
RECRUITING · Phase 3
-
Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
RECRUITING · Phase 3
-
FUSION: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS)
ACTIVE NOT RECRUITING · Phase 3
-
Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment
ACTIVE NOT RECRUITING · Phase 3
-
An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 (Tofersen) in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)
COMPLETED · Phase 3
-
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01048281 · 100 participants
Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma
- NCT01161199 · 100 participants
The Use of Leukapheresis to Support HIV Pathogenesis Studies
- NCT01327690 · 100 participants · Early Phase 1
Mental Health in Veterans and Families After Group Therapies
- NCT01730781 · 100 participants
Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia