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

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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 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).

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
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
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43 New Scotland Avenue
Albany, New York 12208
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
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8550 Marshall Dr.
Lenexa, Kansas 66214
913-894-1500
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8 Mirror Lake Dr # A
Ormond Beach, Florida 32174
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Pompano Beach, Florida 33060
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60 Crittenden Blvd # 70
Rochester, New York 14642
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
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Atlanta, Georgia 30309
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Aurora, Colorado 80045
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733 North Broadway
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Berkeley, California
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Ciudad Autonoma de Buenos Aires, Buenos Aires C1126
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2049 E 100th St
Cleveland, Ohio 44106
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Clinton Township, Michigan 48035
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Orange, California 92868
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350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
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Stony Brook, New York 11794
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314 Martin Luther King Junior Way
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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Wilkes-Barre, Pennsylvania 18711
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