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CompletedNCT00332007Updated Aug 31, 2009

Tonabersat in the Prophylaxis of Migraine With Aura

A Phase 2 interventional study of Tonabersat and Placebo in Migraine With Aura, sponsored by Minster Research Ltd. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-08-31.

Sponsored by Minster Research Ltd · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Migraine With Aura
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 39 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Minster Research Ltd is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    1

    Tonabersat 40 mg daily

    Drug: Tonabersat

  • Placebo comparator
    2

    Drug: Placebo

Interventions

  • DrugTonabersat

    two tablets once daily

  • DrugPlacebo

    two tablets once daily

06

What researchers measure

Primary outcomes

  1. Difference in the mean number of aura attacks experienced between treatment groups

    Time frame: 12 week treatment period

  2. Difference in the mean number of migraine headache days between treatment groups

    Time frame: 12 week treatment period

  3. Incidence of adverse events

    Time frame: 12 week treatment period

Secondary outcomes

  1. Mean number of headache days in each treatment period.

    Time frame: 12 week treatment period

  2. Mean number of auras followed by headache in each treatment period.

    Time frame: 12 week treatment period

  3. Mean number of headache days in each month of treatment in each treatment period.

    Time frame: Mean monthly

  4. Mean number of auras and/or migraine headache during each treatment period.

    Time frame: 12 week treatment period

  5. Mean number of migraine headache attacks in each treatment period.

    Time frame: 12 week treatment period

  6. Speed of effect of treatment.

    Time frame: First month for which difference between treatments identified

  7. Mean monthly consumption of rescue medication.

    Time frame: Mean monthly

  8. Mean duration of auras in each treatment period.

    Time frame: Mean over 12 week treatment period

  9. Mean number of symptoms associated with auras in each treatment period.

    Time frame: 12 week treatment period

07

Study locations

1 site
  • Danish Headache Centre, Department of Neurology, Glostrup Hospital
    Copenhagen, Denmark
08

References and documents

Publications

  • 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. PubMed 19570717 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00332007
Lead sponsor
Minster Research Ltd
Collaborators
University of Copenhagen
First posted
May 31, 2006
Start date
May 2006
Primary completion
Aug 2008
Completion
Aug 2008
Last update
Aug 31, 2009

Study contacts

Jes Olesen, MD
principal investigator · University of Copenhagen, Department of Neurology, Glostrup Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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