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

Purpose

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	Intervention	Phase
Amyotrophic Lateral Sclerosis	Drug: AVP-923	Phase III

Genetics Home Reference related topics:

amyotrophic lateral sclerosis

MedlinePlus related topics:

Amyotrophic Lateral Sclerosis

Drug Information available for:

Dextromethorphan Dextromethorphan hydrobromide Levomethorphan Racemethorphan Quinidine Avp 923 Quinidine polygalacturonate Quinidine sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Avanir Pharmaceuticals:

Estimated Enrollment:	100
Study Start Date:	January 2001
Estimated Study Completion Date:	March 2002

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021697

Locations


United States, California
	Loma Linda University Dept. of Neurology
	Loma Linda, California, United States, 92354
	UCLA School of Medicine Dept. of Neurology
	Los Angeles, California, United States, 90095
	University of California, San Francisco
	San Francisco, California, United States, 94143

United States, Colorado
	University of Colorado Health Sciences
	Denver, Colorado, United States, 80262

United States, Florida
	University of Miami Dept. of Neurology
	Miami, Florida, United States, 33136

United States, Illinois
	Northwestern Medical School
	Chicago, Illinois, United States, 60611

United States, Maryland
	Johns Hopkins University
	Baltimore, Maryland, United States, 21287

United States, Massachusetts
	Massachusetts General Hospital
	Boston, Massachusetts, United States, 02114

United States, New York
	Columbia-Presbyterian Center Neurological Institute
	New York, New York, United States, 10032
	State University of New York
	Syracuse, New York, United States, 13210

United States, North Carolina
	Wake Forest University
	Winston Salem, North Carolina, United States, 27157
	Carolinas Medical Center Carolinas Neuromuscular/ALS-MDA Center
	Charlotte, North Carolina, United States, 28203

United States, Ohio
	Cleveland Clinic Foundation
	Cleveland, Ohio, United States, 44195

United States, Pennsylvania
	MCP-Hahnemann University Dept. of Neurology
	Philadelphia, Pennsylvania, United States, 19107
	Penn Neurological Institute
	Philadelphia, Pennsylvania, United States, 19107

United States, Texas
	University of Texas Health Science Center @ San Antonio
	San Antonio, Texas, United States, 78229

United States, Wisconsin
	University of Wisconsin ALS Clinical Research Center
	Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

Avanir Pharmaceuticals

More Information

Home page of the Muscular Dystrophy Association This link exits the ClinicalTrials.gov site

Sponsor's website This link exits the ClinicalTrials.gov site

Homepage for ALSA/ALS This link exits the ClinicalTrials.gov site

Publications:

Dark FL, McGrath JJ, Ron MA. Pathological laughing and crying. Aust N Z J Psychiatry. 1996 Aug;30(4):472-9. Review.

Smith RA, Moore SR, Gresham LS, Manley PE, Licht JM: The treatment of affective lability with dextromethorphan. Neurology 54: 604P, 1995

Gallagher JP. Pathologic laughter and crying in ALS: a search for their origin. Acta Neurol Scand. 1989 Aug;80(2):114-7.

Wolf JK, Santana HB, Thorpy M. Treatment of "emotional incontinence" with levodopa. Neurology. 1979 Oct;29(10):1435-6. No abstract available.

Muller U, Murai T, Bauer-Wittmund T, von Cramon DY. Paroxetine versus citalopram treatment of pathological crying after brain injury. Brain Inj. 1999 Oct;13(10):805-11.

Moore SR, Gresham LS, Bromberg MB, Kasarkis EJ, Smith RA. A self report measure of affective lability. J Neurol Neurosurg Psychiatry. 1997 Jul;63(1):89-93.

Schadel M, Wu D, Otton SV, Kalow W, Sellers EM. Pharmacokinetics of dextromethorphan and metabolites in humans: influence of the CYP2D6 phenotype and quinidine inhibition. J Clin Psychopharmacol. 1995 Aug;15(4):263-9.

Study ID Numbers:	99-AVR-102, AVP-923
First Received:	August 1, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00021697
Health Authority:	United States: Food and Drug Administration

Keywords provided by Avanir Pharmaceuticals:

AVP-923

Dextromethorphan

Quinidine

Pseudobulbar Affect

Study placed in the following topic categories:

Excitatory Amino Acids

Spinal Cord Diseases

Central Nervous System Diseases

Sclerosis

Degenerative motor system disease

Neurodegenerative Diseases

Motor neuron disease

Naphazoline

Oxymetazoline

Amyotrophic lateral sclerosis

Neuromuscular Diseases

Guaifenesin

Phenylephrine

Amyotrophic Lateral Sclerosis

Quinidine

Dextromethorphan

Lou Gehrig's disease

Phenylpropanolamine

Motor Neuron Disease

Additional relevant MeSH terms:

Respiratory System Agents

Neurotransmitter Agents

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Excitatory Amino Acid Agents

Antitussive Agents

Central Nervous System Agents

Pharmacologic Actions

Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Avanir Pharmaceuticals
Information provided by:	Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00021697