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Completed Phase 3 Interventional

Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS

ClinicalTrials.gov ID: NCT00021697

Public ClinicalTrials.gov record NCT00021697. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 6:25 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double-Blind Controlled, Multicenter Phase II/III Study to Assess the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect in Patients With Amyotrophic Lateral Sclerosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00021697
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Avanir Pharmaceuticals
Industry
Enrollment
100 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 2001 (Type not available)
Primary completion
Apr 2002 (Actual)
Completion
Apr 2002 (Actual)
Last update posted
Jul 14, 2016

2001 – 2002

United States locations

U.S. sites
17
U.S. states
12
U.S. cities
16
Facility City State ZIP Site status
Loma Linda University Dept. of Neurology Loma Linda California 92354 —
UCLA School of Medicine Dept. of Neurology Los Angeles California 90095 —
University of California, San Francisco San Francisco California 94143 —
University of Colorado Health Sciences Denver Colorado 80262 —
University of Miami Dept. of Neurology Miami Florida 33136 —
Northwestern Medical School Chicago Illinois 60611 —
Johns Hopkins University Baltimore Maryland 21287 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Columbia-Presbyterian Center Neurological Institute New York New York 10032 —
State University of New York Syracuse New York 13210 —
Carolinas Medical Center Carolinas Neuromuscular/ALS-MDA Center Charlotte North Carolina 28203 —
Wake Forest University Winston-Salem North Carolina 27157 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
MCP-Hahnemann University Dept. of Neurology Philadelphia Pennsylvania 19107 —
Penn Neurological Institute Philadelphia Pennsylvania 19107 —
University of Texas Health Science Center @ San Antonio San Antonio Texas 78229 —
University of Wisconsin ALS Clinical Research Center Madison Wisconsin 53792 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00021697, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 14, 2016 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00021697 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →