AzTrials
AzTrials

Migraine With AuraPhase 2NCT00332007

Tonabersat in the Prophylaxis of Migraine With Aura

A Phase 2 study testing Tonabersat in people with Migraine With Aura, run by Minster Research Ltd at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine With Aura
What is being tested?
Tonabersat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
1 siteDenmark
Study dates
May 2006to Aug 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Danish Headache Centre, Department of Neurology, Glostrup Hospital

    Copenhagen

Other trials in Denmark

About this study

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

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

Being tested
Tonabersat, Placebo
Medical subject headings
Migraine with Aura

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TonabersatDrug

    two tablets once daily

  • PlaceboDrug

    two tablets once daily

Study groups in NCT00332007
Study groupRoleWhat they receive
1ExperimentalTonabersat 40 mg daily
Receives: Drug: Tonabersat
2Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 week treatment period

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

    Measured: 12 week treatment period

  3. Incidence of adverse events

    Measured: 12 week treatment period

Secondary outcomes (9)

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

    Measured: 12 week treatment period

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

    Measured: 12 week treatment period

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

    Measured: Mean monthly

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

    Measured: 12 week treatment period

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

    Measured: 12 week treatment period

  6. Speed of effect of treatment.

    Measured: First month for which difference between treatments identified

  7. Mean monthly consumption of rescue medication.

    Measured: Mean monthly

  8. Mean duration of auras in each treatment period.

    Measured: Mean over 12 week treatment period

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

    Measured: 12 week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionAug 2008
  4. Study completionAug 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00332007
Sponsor's protocol ID
TON/02/05-CLIN
Status last verified
Aug 2009
First submitted
30 May 2006
Last updated
31 Aug 2009
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tonabersat in people with Migraine With Aura, run by Minster Research Ltd at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in the mean number of aura attacks experienced between treatment groups (time frame: 12 week treatment period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00332007, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2009; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in