IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Tonabersat in the Prophylaxis of Migraine With Aura
This study has been completed.
Sponsor:
Minster Research Ltd
Collaborator:
University of Copenhagen
Information provided by:
Minster Research Ltd
ClinicalTrials.gov Identifier:
NCT00332007
First received: May 30, 2006
Last updated: August 28, 2009
Last verified: August 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Participant, 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:
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 ]
- 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 ]
Secondary Outcome Measures:
- 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 ]
| 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 (Adult) |
| Sexes Eligible for Study: | All |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332007
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:
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.
| 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 |
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 July 18, 2017