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Sponsored by: |
Minster Research Ltd |
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Information provided by: | Minster Research Ltd |
ClinicalTrials.gov Identifier: | NCT00311662 |
Overall trial objectives:
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
Condition | Intervention | Phase |
---|---|---|
Migraine Without Aura Migraine With Aura |
Drug: Tonabersat Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Multi-Centre, Parallel Group, Double-Blind, Placebo Controlled Study of the Efficacy and Tolerability of Tonabersat in the Prophylaxis of Migraine Headache |
Enrollment: | 124 |
Study Start Date: | April 2006 |
Study Completion Date: | October 2006 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Tonabersat 40mg
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Drug: Tonabersat
Tablet 40mg daily for 12 weeks
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2: Placebo Comparator |
Drug: Placebo
Tablet once daily for 12 weeks
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Glostrup Amtssygehus, Neurologisk Ambulatorium N01 | |
Copenhagen, Denmark, Glostrup 2600 | |
Bispebjerg Hospital, Neurolgisk Afdeling N | |
Copenhagen, Denmark, Kobenhavn NV 2400 | |
Hungary | |
Kenézy Gyula County Hospital, Dept of Neurology | |
Debrecen, Hungary, Debrecen 1145 | |
Petz Aladár Megyei Oktató Kórház | |
Gyor, Hungary, Gyor 9024 | |
Zala County Hospital, Department of Cardiology | |
Zalaegerszeg, Hungary, Zalaegerszeg 8900 | |
Borsod Abauj Zemplén Megyei Kórház, Neurologiai Osztaly | |
Miskolc, Hungary, Miskolc 3526 | |
South Africa | |
Chris Barnard Memorial Hospital | |
Cape Town, South Africa, West Cape 8001 | |
Pretoria East Hospital, Neuro-Orthopaedic Unit | |
Pretoria, South Africa, Gauteng 0044 | |
SCION Clinical Research, 316 Medi-Clinic Heart Hospital | |
Pretoria, South Africa, Guateng 0002 | |
Dr I Engelbrecht | |
Lyttleton, South Africa, Guateng 0157 | |
St. Augustine's Medical Mews | |
Durban, South Africa, KZ-Natal 4001 | |
Little Company of Mary, Neurospinal Building | |
Pretoria, South Africa, Gauteng 0181 | |
Quinta-Med | |
Bloemfontein, South Africa, Bloemfontein 9301 | |
Francois Le Clus | |
Johannesburg, South Africa, Gauteng 1619 | |
Dr J Bouwer | |
Pretoria, South Africa, Gauteng 0082 | |
Intercare Corporate Office | |
Pretoria, South Africa, Gauteng 0081 | |
United Kingdom | |
The National Hospital for Neurology & Neurosurgery | |
London, United Kingdom, WC1N 3BG |
Principal Investigator: | Peter Goadsby, MD | The National Hospital for Neurology and Neurosurgery, London |
Study ID Numbers: | TON/01/05-CLIN |
Study First Received: | April 4, 2006 |
Last Updated: | August 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00311662 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Denmark: Danish Medicines Agency; South Africa: Medicines Control Council; Hungary: National Institute of Pharmacy |
Migraine Disorders Headache Central Nervous System Diseases Headache Disorders, Primary |
Migraine with Aura Brain Diseases Headache Disorders Migraine without Aura |
Migraine Disorders Nervous System Diseases Central Nervous System Diseases Headache Disorders, Primary |
Migraine with Aura Brain Diseases Headache Disorders Migraine without Aura |