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A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients With Multiple Sclerosis
The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 capsules in the treatment of central neuropathic pain in participants with multiple sclerosis.
The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 (dextromethorphan \[DM\]/quinidine \[Q\]) capsules containing either 45 mg DM and 10 mg Q (AVP-923-45) or 30 mg DM and 10 mg Q (AVP-923-30) or 20 mg DM and 10 mg Q (AVP-923-20) compared to placebo, for the treatment of central neuropathic pain in a population of participants with multiple sclerosis (MS) over a 12-week period. The MS participant population enrolled includes participants with relapsing-remitting multiple sclerosis (RRMS) and participants with secondary progressive multiple sclerosis (SPMS).
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
No
North Central Neurology Associates PC
Cullman, Alabama, United States
St. Joseph's Hospital Medical Center
Phoenix, Arizona, United States
Alta Bates Summit Medical Center
Berkeley, California, United States
University of California, Irvine
Orange, California, United States
Coordinated Clinical Research
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
Neurology Associates, PA
Maitland, Florida, United States
Collier Neurologic Specialists
Naples, Florida, United States
Laszlo J. Mate, MD
North Palm Beach, Florida, United States
Start Date
September 8, 2011
Primary Completion Date
September 26, 2013
Completion Date
September 26, 2013
Last Updated
November 22, 2021
209
ACTUAL participants
AVP-923-45
DRUG
AVP-923-30
DRUG
AVP-923-20
DRUG
Placebo
DRUG
Lead Sponsor
Avanir Pharmaceuticals
NCT06276634
NCT07225504
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06809192