Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
39 participants
INTERVENTIONAL
2006-05-31
2008-08-31
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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1
Tonabersat 40 mg daily
Tonabersat
two tablets once daily
2
Placebo
two tablets once daily
Interventions
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Tonabersat
two tablets once daily
Placebo
two tablets once daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
Minster Research Ltd
INDUSTRY
Responsible Party
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University of Copenhagen
Principal Investigators
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Jes Olesen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen, Department of Neurology, Glostrup Hospital
Locations
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Danish Headache Centre, Department of Neurology, Glostrup Hospital
Copenhagen, , Denmark
Countries
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References
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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.
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.
Other Identifiers
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TON/02/05-CLIN
Identifier Type: -
Identifier Source: org_study_id