Efficacy and Tolerability of Tonabersat in the Prophylaxis of Migraine Headache

August 28, 2009 updated by: Minster Research Ltd

Multi-centre, Parallel Group, Double-blind, Placebo Controlled Study of the Efficacy and Tolerability of Tonabersat in the Prophylaxis of Migraine Headache

Overall trial objectives:

  • Can treatment with tonabersat reduce the number of days with a migraine headache in patients who suffer from frequent migraine attacks
  • 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 migraine and so be effective as prophylactic treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, Glostrup 2600
        • Glostrup Amtssygehus, Neurologisk Ambulatorium N01
      • Copenhagen, Denmark, Kobenhavn NV 2400
        • Bispebjerg Hospital, Neurolgisk Afdeling N
  • Hungary
      • Debrecen, Hungary, Debrecen 1145
        • Kenézy Gyula County Hospital, Dept of Neurology
      • Gyor, Hungary, Gyor 9024
        • Petz Aladár Megyei Oktató Kórház
      • Miskolc, Hungary, Miskolc 3526
        • Borsod Abauj Zemplén Megyei Kórház, Neurologiai Osztaly
      • Zalaegerszeg, Hungary, Zalaegerszeg 8900
        • Zala County Hospital, Department of Cardiology
  • South Africa
      • Bloemfontein, South Africa, Bloemfontein 9301
        • Quinta-Med
      • Cape Town, South Africa, West Cape 8001
        • Chris Barnard Memorial Hospital
      • Durban, South Africa, KZ-Natal 4001
        • St. Augustine's Medical Mews
      • Johannesburg, South Africa, Gauteng 1619
        • Francois Le Clus
      • Lyttleton, South Africa, Guateng 0157
        • Dr I Engelbrecht
      • Pretoria, South Africa, Gauteng 0044
        • Pretoria East Hospital, Neuro-Orthopaedic Unit
      • Pretoria, South Africa, Gauteng 0081
        • Intercare Corporate Office
      • Pretoria, South Africa, Gauteng 0082
        • Dr J Bouwer
      • Pretoria, South Africa, Gauteng 0181
        • Little Company of Mary, Neurospinal Building
      • Pretoria, South Africa, Guateng 0002
        • SCION Clinical Research, 316 Medi-Clinic Heart Hospital
  • United Kingdom
      • London, United Kingdom, WC1N 3BG
        • The National Hospital for Neurology & Neurosurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • An established history of migraine of at least one year, with or without aura, meeting the diagnostic criteria of the International Classification of Headache Disorders, and experience between four and 14 migraine headache days per month; headache days should be experienced within at least two and no more than six migraine attacks per month.
  • Women of child bearing potential must be using a reliable form of contraception (defined in the protocol) for at least three months prior to enrolment with contraception maintained for at least 7 days after the last dose of study medication and they must have a negative pregnancy test at screening with no intention of becoming pregnant during the study period.

Exclusion Criteria:

  • Patients with a diagnosis of migraine according to the diagnostic criteria of the International Classification of Headache Disorders at age 50 years or more.
  • Experience frequent non-migraine headache
  • Patients with pure menstrual migraine defined as patients in whom migraine attacks occur exclusively on Day 1 +/- 2 (i.e. Days -2 to +3) of menstruation in at least two out of three menstrual cycles and at no other times of the cycle.
  • Patients with other significant central nervous system disorders in the opinion of the investigator.
  • Failure to respond to more than two adequately dosed (i.e. recommended total daily dose and of sufficient duration) migraine prophylactic medications.
  • Overuse of acute migraine treatments defined as more than 14 medication days per month with analgesics and opioids and nine medication days per month of ergots or triptans.
  • Prophylactic treatment within two months prior to entry to the trial.
  • Patients taking any of the following medications: beta-blockers (during the last two months), tricyclic antidepressants (during the last two months), antiepileptic drugs (during the last two months), calcium channel blockers (during the last two months), monoamine oxidase inhibitors (during the last two months), daily oral NSAIDs, daily paracetamol, high dose magnesium supplements (600 mg/day), daily multivitamin preparations containing more than 10 mg riboflavin, daily use of oral corticosteroids and daily herbal preparations (e.g. feverfew, butterwort and St John's Wort). Parenteral administration of Botulinum toxin is also excluded. Patients taking other medications used as prophylaxis for migraine including methysergide, anti spasticity agents (e.g. tizanidine) and the new generation antipsychotics (e.g. olanzapine) currently or within the previous two months should also be excluded.
  • 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 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 (aspartate aminotransferase [AST], alanine aminotransferase [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.
  • Failure to complete the diary card during the baseline period.
  • Participation in another clinical trial in the previous four weeks.
  • Any women who is pregnant, lactating or not using medically acceptable contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Placebo
Tablet once daily for 12 weeks
Experimental: 1
Tonabersat 40mg
Drug: Tonabersat
Tablet 40mg daily for 12 weeks
Other Names:
  • SB220453

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the mean monthly number of migraine headache days from the baseline period to Month 3.
Time Frame: weeks 8 to 12 compared to weeks -4 to 0
weeks 8 to 12 compared to weeks -4 to 0
Incidence of all adverse events (AEs), serious AEs and AEs leading to withdrawal of trial medication, clinical laboratory tests, vital signs and physical examination
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the mean monthly number of migraine headache days from the baseline period to across the whole treatment period.
Time Frame: weeks 0-12 compared to weeks -4 to 0
weeks 0-12 compared to weeks -4 to 0
Proportion of patients defined as a responder, i.e. those with a reduction of at least 50% in the mean monthly number of migraine headache days in the third month of treatment and over the whole treatment period.
Time Frame: weeks 8-12 compared to weeks -4 to 0
weeks 8-12 compared to weeks -4 to 0
Change in mean monthly number of migraine attacks from the baseline period to Month 3.
Time Frame: weeks 8-12 compared to weeks -4 to 0
weeks 8-12 compared to weeks -4 to 0
Change in mean monthly number of migraine attacks from the baseline period to across the whole treatment period.
Time Frame: weeks 0 to 12 compared to weeks -4 to 0
weeks 0 to 12 compared to weeks -4 to 0
Proportion of patients defined as a responder, i.e. those with a reduction of at least 50% in the mean monthly frequency of migraine attacks in the third month of treatment and over the whole treatment period.
Time Frame: weeks 8-12 compared to weeks -4 to 0
weeks 8-12 compared to weeks -4 to 0
Speed of effect of treatment.
Time Frame: 12 weeks
12 weeks
Change in the mean monthly consumption of rescue medication from the baseline period to Month 3.
Time Frame: weeks 8 to 12 compared to weeks -4 to 0
weeks 8 to 12 compared to weeks -4 to 0
Change in the mean monthly consumption of rescue medication from the baseline period to across the whole treatment period.
Time Frame: weeks 0 to 12 comoared to weeks -4 to 0
weeks 0 to 12 comoared to weeks -4 to 0
Overall severity of migraine attacks occurring during the treatment period.
Time Frame: 12 weeks
12 weeks
Overall response to the question "How satisfied are you with the trial medication?"
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minster Research Ltd

Investigators

  • Principal Investigator: Peter Goadsby, MD, The National Hospital for Neurology and Neurosurgery, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

April 4, 2006

First Submitted That Met QC Criteria

April 4, 2006

First Posted (Estimate)

April 6, 2006

Study Record Updates

Last Update Posted (Estimate)

August 31, 2009

Last Update Submitted That Met QC Criteria

August 28, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TON/01/05-CLIN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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