ClinicalTrials.gov record
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 May 5, 2026, 6:07 AM 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

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

  • AVP-923 Drug

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
Dec 31, 2000
Primary completion
Mar 31, 2002
Completion
Mar 31, 2002
Last update posted
Jul 13, 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 13, 2016 · Synced May 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00021697 live on ClinicalTrials.gov.

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