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
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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University of Rochester The University of Rochester is one of the country's top-tier research universities....
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University of South Florida The University of South Florida is a high-impact, global research university...
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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...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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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...
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Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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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...
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