Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
Status: | Completed |
---|---|
Conditions: | Neurology, Multiple Sclerosis |
Therapuetic Areas: | Neurology, Other |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 7/5/2018 |
Start Date: | September 2011 |
End Date: | September 2013 |
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 patients with multiple
sclerosis.
of AVP-923 capsules 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 (dextromethorphan [DM]/quinidine [Q])capsules containing either 45 mg DM and 10 mg
Q (AVP-923-45) or 30 mg DM 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 patients with
multiple sclerosis (MS) over a 12-week period. The MS patients population enrolled includes
patients with relapsing-remitting multiple sclerosis (RRMS) and patients with secondary
progressive multiple sclerosis (SPMS).
of AVP-923 (dextromethorphan [DM]/quinidine [Q])capsules containing either 45 mg DM and 10 mg
Q (AVP-923-45) or 30 mg DM 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 patients with
multiple sclerosis (MS) over a 12-week period. The MS patients population enrolled includes
patients with relapsing-remitting multiple sclerosis (RRMS) and patients with secondary
progressive multiple sclerosis (SPMS).
Main Inclusion Criteria:
Multiple Sclerosis (RRMS or SPMS), Clinical history and symptoms of central neuropathic
pain (dysesthetic pain)for at least 3 months prior to screening, PRS baseline score = or >
4, No MS relapse within previous 30 days.
Main Exclusion Criteria:
Personal history of complete heart block, QTc prolongation, or torsades de pointes, family
history of congenital QT interval prolongation syndrome, Myasthenia Gravis, BDI score > 19
We found this trial at
45
sites
University of Rochester The University of Rochester is one of the country's top-tier research universities....
Click here to add this to my saved trials
Click here to add this to my saved trials
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
Click here to add this to my saved trials
Click here to add this to my saved trials
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
Click here to add this to my saved trials
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
University of South Florida The University of South Florida is a high-impact, global research university...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
733 North Broadway
Baltimore, Maryland 21205
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
2900 W Queen Ln
Philadelphia, Pennsylvania 19129
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
Click here to add this to my saved trials
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
Click here to add this to my saved trials
Click here to add this to my saved trials
314 Martin Luther King Junior Way
Tacoma, Washington 98405
Tacoma, Washington 98405
(253) 403-5200
Multicare Health System MultiCare is a not-for-profit health care organization with more than 10,000 employees...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials