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
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