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 purpose of this study is to determine if the study drug, AVP-923 is safe and to see if it helps with reducing the symptoms of central neuropathic pain in patients diagnosed with either relapsing remitting or secondary progressive MS (RRMS or SPMS) compared to placebo. AVP-923 is a combination of two drugs (dextromethorphan and quinidine) and is given orally (a pill).
Three different doses of AVP-923 will be tested against placebo. A placebo medication is one that contains no active substance but may resemble a real medication. Participants will be assigned to receive one of the following four study drugs:
• Placebo
• AVP-923-45/10 (45 mg dextromethorphan and 10 mg quinidine)
• AVP-923-30/10(30 mg dextromethorphan and 10 mg quinidine)
• AVP-923-20/10 (20 mg dextromethorphan and 10 mg quinidine)
Participants have a 75% (3 out of 4) chance of being assigned to one of the doses of AVP-923 and a 25% (1 out of 4) chance of being assigned to placebo.
The study will take up to 17 weeks.
If you have been diagnosed with relapsing remitting multiple sclerosis (RRMS) or secondary progressive (SPMS), are between the ages of 18-85, are able to come to UCSF for study visits and have been diagnosed with neuropathic pain, you may be eligible to participate.
For more information, Nancy Shum at .(JavaScript must be enabled to view this email address) with "AVANIR Pain Study inquiry” in the subject line or at (415) 502 7219.
