NCT00534560

Dose Ranging Study of the Efficacy and Tolerability of Tonabersat in the Prophylaxis of Migraine Headache

Multi-Centre, Parallel Group, Double-Blind, Placebo Controlled, Dose Ranging Study of the Efficacy and Tolerability of Tonabersat in the Prophylaxis of Migraine Headache and Open Label Extension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 542 (actual)
• Sponsor: Minster Research Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Primary objective: To investigate the efficacy and tolerability of two doses of tonabersat compared to placebo in the prophylaxis of migraine headache and to evaluate the longer term tolerability of tonabersat in an open label extension. Secondary objective(s): To obtain further data on the efficacy and dose response of tonabersat; To extend the safety and tolerability database of tonabersat; To obtain data on the pharmacokinetics of tonabersat.

Detailed description

A multi-centre, double-blind, placebo controlled, randomized, parallel group, dose ranging study to investigate the efficacy and tolerability of two different target doses of tonabersat and placebo in the prophylaxis of migraine. Following initial screening patients will enter a 4 week baseline assessment period, prior to randomization to one of three treatment groups. Subsequently patients will be allocated, according to the predetermined randomization schedule, to treatment with placebo or a target dose of tonabersat 40 mg/day or 80 mg/day in a 20 week treatment period. A dose titration regimen will be employed over a period of 4 weeks and treatment will then be maintained for a further 16 weeks. During the baseline assessment period and the treatment period patients will maintain a daily record (diary data) of the occurrence of migraine headache, the severity of an attack, the presence/absence of a preceding aura, other symptoms associated with the migraine and details of the use of rescue medication (patients will be permitted to use their usual symptomatic/acute treatment as rescue medication throughout the trial). Patients will attend the clinic for assessment and collection of blood and urine samples for laboratory analysis, and a sub-population of patients will participate in a pharmacokinetic study. A total of 7 visits are planned during the randomized double-blind treatment period. On completion of the randomized double-blind treatment period all patients will be offered the opportunity to enter an open label extension study where all patients receive tonabersat. A dose titration regimen will be employed over a period of 1 month and the final assigned dose of tonabersat (40, 60 or 80 mg/day) will be continued for the next 12 months. During the open label extension patients will attend the clinic for regular assessment of migraine status and safety. A total of 5 visits are planned.

Conditions

• Migraine Without Aura
• Migraine With Aura

Interventions

Type	Name	Description
DRUG	Tonabersat	Tablets, 4 week dose titration and 16 weeks treatment at target dose of 40 mg per day
DRUG	Tonabersat	Tablets: 4 week titration and 16 weeks at target dose of 80 mg per day
DRUG	Placebo	Tablets; 4 week dose titration with 16 weeks at target dose

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-11-01
• Completion: 2009-03-01
• First posted: 2007-09-26
• Last updated: 2009-03-31