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

July 13, 2016 updated by: Avanir Pharmaceuticals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • 18 to 80 years of age, inclusive
  • Confirmed diagnosis of ALS or probable ALS
  • Clinical history of pseudobulbar affect
  • If female, must not be pregnant, breast-feeding, or planning a pregnancy during the course of the study, and must have a negative urine pregnancy test prior to start of study
  • If female, must have been practicing an established method of birth control for at least the prior month (oral contraceptive tablets, hormonal implant device, intrauterine device, diaphragm and contraceptive cream or foam, condom with spermicide, tubal ligation, or abstinence) or be surgically sterile or post-menopausal
  • Must be willing to not take any prohibited medications during participation in the study

Exclusion:

  • Known sensitivity to quinidine or opiate drugs (codeine, etc.)
  • On any anti-depressive medication
  • Recently (within two months) diagnosed with ALS
  • Currently participating in, or who within the past 30 days have participated in, the study of another investigational new drug
  • Previously received treatment with co-administration of dextromethorphan and quinidine
  • History of substance abuse within the past two years
  • Women who are pregnant or likely to become pregnant during the course of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avanir Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (ACTUAL)

April 1, 2002

Study Completion (ACTUAL)

April 1, 2002

Study Registration Dates

First Submitted

August 1, 2001

First Submitted That Met QC Criteria

August 2, 2001

First Posted (ESTIMATE)

August 3, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99-AVR-102
  • AVP-923

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Amyotrophic Lateral Sclerosis

Clinical Trials on AVP-923

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe