A single centre, double-blind, randomised, placebo controlled cross-over study to evaluate the efficacy and tolerability of tonabersat in the prophylaxis of migraine in patients presenting with migraine with aura

• Conditions: Migraine with aura meeting the diagnostic criteria of the International Classification of Headache Disorders (Edition 2)

• Registration Number: EUCTR2006-000210-21-DK
• Lead Sponsor: Prof Jes Olesen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

•Patients with an established history of migraine of at least one year meeting the diagnostic criteria of the International Classification of Headache Disorders – Edition 2 (Appendix 2) and who experience at least one aura a month.

•Male or female patients between 18-65 years of age; women of child bearing potential must be using a reliable form of contraception for at least 3 months prior to enrolment.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients experiencing headache other than migraine or tension headache

•Overuse of acute migraine treatments defined as more than 14 daily doses per month with analgesics or more than 9 daily doses per month of ergots or triptans within the last two months

•Migraine prophylactic treatment within two months prior to entry to the trial

•Patients taking any of the following medications for migraine: beta-blockers, tricyclic antidepressants (during the last 2 months), antiepileptic dugs (during the last 2 months), calcium channel blockers, monoamine oxidase inhibitors, daily NSAIDs, daily paracetamol, high dose magnesium supplements (600mg/day). Parenteral administration of botulinum toxin is also excluded. These drugs are permitted when given for diseases other than migraine provided that, in the opinion of the investigator the dose can be kept constant throughout the trial.

•Patients who, in the opinion of the investigator, have significant cerebrovascular disease e.g. transient ischaemic attacks, stroke

•Patients who, in the opinion of the investigator, have clinically significant cardiovascular disease

•Patients suffering from a current clinical diagnosis of a major depressive disorder or schizophrenia

•Patients with renal dysfunction , defined as a serum creatinine of greater than 125% of the upper limit of normal for their age group

•Patients with hepatic dysfunction defined as a liver function test (AST, ALT, alkaline phosphatase, bilirubin) of greater than twice the upper limit of normal for their age group

•Women who are pregnant or breast feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the efficacy of tonabersat compared to placebo in the reduction of the number of aura attacks and the number of migraine headache days in patients with migraine with aura<br><br><br><br><br><br>;Secondary Objective: To compare the safety and tolerability of tonabersat and placebo in the prophylactic treatment of patients with migraine with aura<br><br>To investigate the efficacy of tonabersat compared to placebo on the number and overall severity of migraine attacks experienced during a three month treatment period together with associated symptoms<br>;Primary end point(s): •Difference in the mean number of aura attacks experienced between treatment groups<br><br>•Difference in the mean number of migraine headache days between treatment groups <br><br>Safety variables include incidence of all adverse events (AEs), serious AEs and AES leading to withdrawal of trial medication, clinical laboratory tests, vital signs and physical examination<br>