Tonabersat in the Prophylaxis of Migraine With Aura - Full Text View

Sponsor:	Minster Research Ltd
Collaborator:	University of Copenhagen
Information provided by:	Minster Research Ltd
ClinicalTrials.gov Identifier:	NCT00332007

Purpose

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

Condition	Intervention	Phase
Migraine With Aura	Drug: Tonabersat Drug: Placebo	Phase II

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

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Tonabersat

U.S. FDA Resources

Further study details as provided by Minster Research Ltd:

Primary Outcome Measures:

Difference in the mean number of aura attacks experienced between treatment groups [ Time Frame: 12 week treatment period ] [ Designated as safety issue: No ]
Difference in the mean number of migraine headache days between treatment groups [ Time Frame: 12 week treatment period ] [ Designated as safety issue: No ]
Incidence of adverse events [ Time Frame: 12 week treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mean number of headache days in each treatment period. [ Time Frame: 12 week treatment period ] [ Designated as safety issue: No ]
Mean number of auras followed by headache in each treatment period. [ Time Frame: 12 week treatment period ] [ Designated as safety issue: No ]
Mean number of headache days in each month of treatment in each treatment period. [ Time Frame: Mean monthly ] [ Designated as safety issue: No ]
Mean number of auras and/or migraine headache during each treatment period. [ Time Frame: 12 week treatment period ] [ Designated as safety issue: No ]
Mean number of migraine headache attacks in each treatment period. [ Time Frame: 12 week treatment period ] [ Designated as safety issue: No ]
Speed of effect of treatment. [ Time Frame: First month for which difference between treatments identified ] [ Designated as safety issue: No ]
Mean monthly consumption of rescue medication. [ Time Frame: Mean monthly ] [ Designated as safety issue: No ]
Mean duration of auras in each treatment period. [ Time Frame: Mean over 12 week treatment period ] [ Designated as safety issue: No ]
Mean number of symptoms associated with auras in each treatment period. [ Time Frame: 12 week treatment period ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	May 2006
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Tonabersat 40 mg daily	Drug: Tonabersat two tablets once daily
Placebo Comparator: 2	Drug: Placebo two tablets once daily

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332007

Locations

Denmark
Danish Headache Centre, Department of Neurology, Glostrup Hospital
Copenhagen, Denmark

Sponsors and Collaborators

Minster Research Ltd

University of Copenhagen

Investigators

Principal Investigator:

Jes Olesen, MD

University of Copenhagen, Department of Neurology, Glostrup Hospital

More Information

Publications:

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. Epub 2009 Jun 29.

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.

Responsible Party:	Professor J Olesen, University of Copenhagen
ClinicalTrials.gov Identifier:	NCT00332007 History of Changes
Other Study ID Numbers:	TON/02/05-CLIN
Study First Received:	May 30, 2006
Last Updated:	August 28, 2009
Health Authority:	Denmark: Danish Medicines Agency

Additional relevant MeSH terms:

Migraine Disorders
Migraine with Aura
Headache Disorders, Primary
Headache Disorders

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012