Study to Assess the Safety and Efficacy of AVP-923 in patients with MS

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  98718

• Contact name

  Carolyn Young

• Sponsor organisation

  Avanir Pharmaceuticals Inc

• Eudract number

  2011-002178-22

• Clinicaltrials.gov Identifier

  NCT01324232

• Research summary

  This is a phase 2, double-blind, randomised, placebo-controlled study funded by Avanir Pharmaceuticals Inc. The research study is being conducted to test the safety, tolerability and efficacy of the study drug, AVP-923 compared with placebo for the treatment of central neuropathic pain in patients with Multiple Sclerosis (MS). The MS patient population eligible for enrollment includes patients with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS). AVP-923 is a combination of two drugs called dextromethorphan (DM) and quinidine (Q). DM is a drug that is available as an over-the-counter cough medication. DM has been tested for treating various types of neurological conditions, including pain and has shown potentially beneficial effects. Q is used, at higher doses, to treat abnormal heart rhythms. DM and Q have been administered in a range of doses in 19 Avanir-sponsored clinical studies and AVP-923 (Nuedexta ?½ - DM 20mg / Q 10mg) has been approved by the FDA for treatment of pseudobulbar affect (PBA). Three different doses of AVP-923 will be tested against placebo. Participants will be randomly assigned to one of the following four study drugs: ?½ Placebo ?½ AVP-923-45/10 (45 mg dextromethorphan and 10 mg quinidine) ?½ AVP-923-30/10(30 mg dextromethorphan and 10 mg quinidine) ?½ AVP-923-20/10 (20 mg dextromethorphan and 10 mg quinidine) Approximately 400 patients will be enrolled in the study in Europe, the US and Argentina. Approximately 60 patients will be enrolled in the UK. The study will take up to 17 weeks, consisting of a screening period (up to 4 week), a treatment period of 12 week, and a follow-up visit (1 week after the last dose of study medication). In total there will be 7 clinic visits and one phone contact. The study involves procedures including physical exam, vital signs, electrocardiograms, blood tests, urine tests, diary cards and patient questionnaires

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  12/NW/0142

• Date of REC Opinion

  27 Apr 2012

• REC opinion

  Further Information Favourable Opinion