Tonabersat in the Prophylaxis of Migraine With Aura

Migraine With Aura Clinical Trial

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 Migraine With Aura

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332007
• Other study ID #: TON/02/05-CLIN
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2006
• Last updated: August 28, 2009
• Start date: May 2006
• Est. completion date: August 2008

Study information

• Verified date: August 2009
• Source: Minster Research Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

Overall trial objectives:

1. Can treatment with tonabersat reduce the number of days with aura and/or migraine headache in patients with migraine with aura

2. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 (defined in the protocol) for at least 3 months prior to enrolment and they must have a negative pregnancy test at screening with no intention of becoming pregnant during the study period

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

• Patients with known alcohol or other substance abuse

• Use of an investigational drug (for any indication) within 30 days or 5 half-lives, whichever is the longer, prior to screening

• Women who are pregnant or breast feeding

• Women of childbearing potential not using a reliable form of contraception

• Patients with any other clinically significant condition which, in the investigators opinion, would render them unsuitable for this study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine with Aura

Intervention

Drug:
• Tonabersat
two tablets once daily
• Placebo
two tablets once daily

Locations

Country	Name	City	State
Denmark	Danish Headache Centre, Department of Neurology, Glostrup Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Minster Research Ltd	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Committee for Proprietary Medicinal Products. Note for guidance on clinical investigation of medicinal products for the treatment of migraine, CPMP/EWP/788/01/Final. London, 17 December 2003.

Hauge AW, Asghar MS, Schytz HW, Christensen K, Olesen J. Effects of tonabersat on migraine with aura: a randomised, double-blind, placebo-controlled crossover study. Lancet Neurol. 2009 Aug;8(8):718-23. doi: 10.1016/S1474-4422(09)70135-8. Epub 2009 Jun 29 — View Citation

International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine (second edition). Cephalalgia 2000; 20:765-86. Committee for Proprietary Medicinal Products. Note for guidance on clinical investigation of medicinal products for the treatment of migraine, CPMP/EWP/788/01/Final. London, 17 December 2003.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the mean number of aura attacks experienced between treatment groups		12 week treatment period	No
Primary	Difference in the mean number of migraine headache days between treatment groups		12 week treatment period	No
Primary	Incidence of adverse events		12 week treatment period	Yes
Secondary	Mean number of headache days in each treatment period.		12 week treatment period	No
Secondary	Mean number of auras followed by headache in each treatment period.		12 week treatment period	No
Secondary	Mean number of headache days in each month of treatment in each treatment period.		Mean monthly	No
Secondary	Mean number of auras and/or migraine headache during each treatment period.		12 week treatment period	No
Secondary	Mean number of migraine headache attacks in each treatment period.		12 week treatment period	No
Secondary	Speed of effect of treatment.		First month for which difference between treatments identified	No
Secondary	Mean monthly consumption of rescue medication.		Mean monthly	No
Secondary	Mean duration of auras in each treatment period.		Mean over 12 week treatment period	No
Secondary	Mean number of symptoms associated with auras in each treatment period.		12 week treatment period	No