Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS
Information source: Avanir Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Amyotrophic Lateral Sclerosis
Intervention: AVP-923 (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Avanir Pharmaceuticals
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Loma Linda University Dept. of Neurology, Loma Linda, California 92354, United States
UCLA School of Medicine Dept. of Neurology, Los Angeles, California 90095, United States
University of California, San Francisco, San Francisco, California 94143, United States
University of Colorado Health Sciences, Denver, Colorado 80262, United States
University of Miami Dept. of Neurology, Miami, Florida 33136, United States
Northwestern Medical School, Chicago, Illinois 60611, United States
Johns Hopkins University, Baltimore, Maryland 21287, United States
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Columbia-Presbyterian Center Neurological Institute, New York, New York 10032, United States
State University of New York, Syracuse, New York 13210, United States
Wake Forest University, Winston Salem, North Carolina 27157, United States
Carolinas Medical Center Carolinas Neuromuscular/ALS-MDA Center, Charlotte, North Carolina 28203, United States
Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States
MCP-Hahnemann University Dept. of Neurology, Philadelphia, Pennsylvania 19107, United States
Penn Neurological Institute, Philadelphia, Pennsylvania 19107, United States
University of Texas Health Science Center @ San Antonio, San Antonio, Texas 78229, United States
University of Wisconsin ALS Clinical Research Center, Madison, Wisconsin 53792, United States
Additional Information
Home page of the Muscular Dystrophy Association Sponsor's website Homepage for ALSA/ALS
Related 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.
Starting date: January 2001
Ending date: March 2002
Last updated: June 23, 2005
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