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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00021697
Recruitment Status : Completed
First Posted : August 3, 2001
Last Update Posted : July 14, 2016
Information provided by:
Avanir Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: AVP-923 Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : January 2001
Actual Primary Completion Date : April 2002
Actual Study Completion Date : April 2002

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00021697

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Sponsors and Collaborators
Avanir Pharmaceuticals
Additional Information:
Publications of Results:
Other Publications:
Layout table for additonal information Identifier: NCT00021697    
Other Study ID Numbers: 99-AVR-102
First Posted: August 3, 2001    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Keywords provided by Avanir Pharmaceuticals:
Pseudobulbar Affect
Additional relevant MeSH terms:
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Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases