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.
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
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- 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
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:
- 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
- Conditions
- Migraine With Aura
- 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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tonabersat 40 mg daily Receives: Drug: Tonabersat |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the mean number of aura attacks experienced between treatment groups
Measured: 12 week treatment period
Difference in the mean number of migraine headache days between treatment groups
Measured: 12 week treatment period
Incidence of adverse events
Measured: 12 week treatment period
Secondary outcomes (9)
Mean number of headache days in each treatment period.
Measured: 12 week treatment period
Mean number of auras followed by headache in each treatment period.
Measured: 12 week treatment period
Mean number of headache days in each month of treatment in each treatment period.
Measured: Mean monthly
Mean number of auras and/or migraine headache during each treatment period.
Measured: 12 week treatment period
Mean number of migraine headache attacks in each treatment period.
Measured: 12 week treatment period
Speed of effect of treatment.
Measured: First month for which difference between treatments identified
Mean monthly consumption of rescue medication.
Measured: Mean monthly
Mean duration of auras in each treatment period.
Measured: Mean over 12 week treatment period
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.
- First posted31 May 2006 (estimated)
- Study startMay 2006
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Migraine With AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Minster Research Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Copenhagen
- Investigators
- Jes Olesen, MD, Principal investigator, University of Copenhagen, Department of Neurology, Glostrup Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00332007
- Acronym / sponsor ID
- TON/02/05-CLIN
- Conditions
- Migraine With Aura
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Minster Research LtdIndustry (pharma, biotech, devices)
- Collaborators
- University of Copenhagen
- Study start
- May 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 31 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TonabersatTonabersat 40 mg daily |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tonabersattwo tablets once daily | Drug | 1 |
| Placebotwo tablets once daily | Drug | 2 |
Primary outcome
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
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2009.
- BackgroundInternational 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.
- BackgroundCommittee 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.
- Results publication: PubMed 19570717Hauge 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jes Olesen, MD principal investigator
University of Copenhagen, Department of Neurology, Glostrup Hospital
1 site in 1 country: see every site and its status.
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.