Tonabersat in the Prophylaxis of Migraine With Aura

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00332007

Recruitment Status : Completed

First Posted : May 31, 2006

Last Update Posted : August 31, 2009

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

University of Copenhagen

Information provided by:

Minster Research Ltd

Tracking Information

First Submitted Date ^ICMJE

May 30, 2006

First Posted Date ^ICMJE

May 31, 2006

Last Update Posted Date

August 31, 2009

Study Start Date ^ICMJE

May 2006

Actual Primary Completion Date

August 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 Measures ^ICMJE

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

Change History

Current Secondary Outcome Measures ^ICMJE

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 Measures ^ICMJE

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

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Tonabersat in the Prophylaxis of Migraine With Aura

Official Title ^ICMJE

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

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 Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Migraine With Aura

Intervention ^ICMJE

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

Study Arms ^ICMJE

Experimental: 1
Tonabersat 40 mg daily

Intervention: Drug: Tonabersat
Placebo Comparator: 2
Intervention: Drug: Placebo

Publications *

Tfelt-Hansen P, Block G, Dahlof C, Diener HC, Ferrari MD, Goadsby PJ, Guidetti V, Jones B, Lipton RB, Massiou H, Meinert C, Sandrini G, Steiner T, Winter PB; International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia. 2000 Nov;20(9):765-86. doi: 10.1046/j.1468-2982.2000.00117.x. No abstract available.
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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

Original Enrollment ^ICMJE

Actual Study Completion Date ^ICMJE

August 2008

Actual Primary Completion Date

August 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 65 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Denmark

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00332007

Other Study ID Numbers ^ICMJE

TON/02/05-CLIN

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

Professor J Olesen, University of Copenhagen

Original Responsible Party

Not Provided

Current Study Sponsor ^ICMJE

Minster Research Ltd

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

University of Copenhagen

Investigators ^ICMJE

Principal Investigator:

Jes Olesen, MD

University of Copenhagen, Department of Neurology, Glostrup Hospital

PRS Account

Minster Research Ltd

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top