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Tonabersat in the Prophylaxis of Migraine With Aura

Primary Purpose

Migraine With Aura

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Tonabersat
Placebo
Sponsored by
Minster Research Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine With Aura

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Danish Headache Centre, Department of Neurology, Glostrup Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Tonabersat 40 mg daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
May 30, 2006
Last Updated
August 28, 2009
Sponsor
Minster Research Ltd
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT00332007
Brief Title
Tonabersat in the Prophylaxis of Migraine With Aura
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Minster Research Ltd
Collaborators
University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Aura

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Tonabersat 40 mg daily
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tonabersat
Intervention Description
two tablets once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
two tablets once daily
Primary Outcome Measure Information:
Title
Difference in the mean number of aura attacks experienced between treatment groups
Time Frame
12 week treatment period
Title
Difference in the mean number of migraine headache days between treatment groups
Time Frame
12 week treatment period
Title
Incidence of adverse events
Time Frame
12 week treatment period
Secondary Outcome Measure Information:
Title
Mean number of headache days in each treatment period.
Time Frame
12 week treatment period
Title
Mean number of auras followed by headache in each treatment period.
Time Frame
12 week treatment period
Title
Mean number of headache days in each month of treatment in each treatment period.
Time Frame
Mean monthly
Title
Mean number of auras and/or migraine headache during each treatment period.
Time Frame
12 week treatment period
Title
Mean number of migraine headache attacks in each treatment period.
Time Frame
12 week treatment period
Title
Speed of effect of treatment.
Time Frame
First month for which difference between treatments identified
Title
Mean monthly consumption of rescue medication.
Time Frame
Mean monthly
Title
Mean duration of auras in each treatment period.
Time Frame
Mean over 12 week treatment period
Title
Mean number of symptoms associated with auras in each treatment period.
Time Frame
12 week treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jes Olesen, MD
Organizational Affiliation
University of Copenhagen, Department of Neurology, Glostrup Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Headache Centre, Department of Neurology, Glostrup Hospital
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
19570717
Citation
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.
Results Reference
result

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Tonabersat in the Prophylaxis of Migraine With Aura

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