Clinical Trial: Tonabersat in the Prophylaxis of Migraine With Aura
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Single Centre, Double-blind, Randomised, Placebo Controlled Crossover Study to Evaluate the Efficacy and Tolerability of Tonabersat in the Prophylaxis of Migraine in Patients Presenting With
Brief Summary:
Overall trial objectives:
- Can treatment with tonabersat reduce the number of days with aura and/or migraine headache in patients with migraine with aura
- How well tolerated is treatment with tonabersat
The study is based on the hypothesis that the unique mechanism of action of tonabersat will inhibit some of the early events in the generation of aura and migraine headache and so be effective as prophylactic treatment
Detailed Summary:
Sponsor: Minster Research Ltd
Current Primary Outcome:
- Difference in the mean number of aura attacks experienced between treatment groups [ Time Frame: 12 week treatment period ]
- Difference in the mean number of migraine headache days between treatment groups [ Time Frame: 12 week treatment period ]
- Incidence of adverse events [ Time Frame: 12 week treatment period ]
Original Primary Outcome:
- Difference in the mean number of aura attacks experienced between treatment groups
- Difference in the mean number of migraine headache days between treatment groups
- Incidence of adverse events
Current Secondary Outcome:
- Mean number of headache days in each treatment period. [ Time Frame: 12 week treatment period ]
- Mean number of auras followed by headache in each treatment period. [ Time Frame: 12 week treatment period ]
- Mean number of headache days in each month of treatment in each treatment period. [ Time Frame: Mean monthly ]
- Mean number of auras and/or migraine headache during each treatment period. [ Time Frame: 12 week treatment period ]
- Mean number of migraine headache attacks in each treatment period. [ Time Frame: 12 week treatment period ]
- Speed of effect of treatment. [ Time Frame: First month for which difference between treatments identified ]
- Mean monthly consumption of rescue medication. [ Time Frame: Mean monthly ]
- Mean duration of auras in each treatment period. [ Time Frame: Mean over 12 week treatment period ]
- Mean number of symptoms associated with auras in each treatment period. [ Time Frame: 12 week treatment period ]
Original Secondary Outcome:
- Mean number of headache days in each treatment period.
- Mean number of auras followed by headache in each treatment period.
- Mean number of headache days in each month of treatment in each treatment period.
- Mean number of auras and/or migraine headache during each treatment period.
- Mean number of migraine headache attacks in each treatment period.
- Speed of effect of treatment.
- Mean monthly consumption of rescue medication.
- Mean duration of auras in each treatment period.
- Mean number of symptoms associated with auras in each treatment period.
- Number of patients defined as a responder
Information By: Minster Research Ltd
Dates:
Date Received: May 30, 2006
Date Started: May 2006
Date Completion:
Last Updated: August 28, 2009
Last Verified: August 2009
