Efficacy and Tolerability of Tonabersat in the Prophylaxis of Migraine Headache
NCT ID: NCT00311662
Last Updated: 2009-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2006-04-30
2006-10-31
Brief Summary
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* 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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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1
Tonabersat 40mg
Tonabersat
Tablet 40mg daily for 12 weeks
2
Placebo
Tablet once daily for 12 weeks
Interventions
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Tonabersat
Tablet 40mg daily for 12 weeks
Placebo
Tablet once daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Minster Research Ltd
INDUSTRY
Principal Investigators
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Peter Goadsby, MD
Role: PRINCIPAL_INVESTIGATOR
The National Hospital for Neurology and Neurosurgery, London
Locations
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Glostrup Amtssygehus, Neurologisk Ambulatorium N01
Copenhagen, , Denmark
Bispebjerg Hospital, Neurolgisk Afdeling N
Copenhagen, , Denmark
Kenézy Gyula County Hospital, Dept of Neurology
Debrecen, , Hungary
Petz Aladár Megyei Oktató Kórház
Győr, , Hungary
Borsod Abauj Zemplén Megyei Kórház, Neurologiai Osztaly
Miskolc, , Hungary
Zala County Hospital, Department of Cardiology
Zalaegerszeg, , Hungary
Quinta-Med
Bloemfontein, , South Africa
Chris Barnard Memorial Hospital
Cape Town, , South Africa
St. Augustine's Medical Mews
Durban, , South Africa
Francois Le Clus
Johannesburg, , South Africa
Dr I Engelbrecht
Lyttleton, , South Africa
Pretoria East Hospital, Neuro-Orthopaedic Unit
Pretoria, , South Africa
Intercare Corporate Office
Pretoria, , South Africa
Dr J Bouwer
Pretoria, , South Africa
Little Company of Mary, Neurospinal Building
Pretoria, , South Africa
SCION Clinical Research, 316 Medi-Clinic Heart Hospital
Pretoria, , South Africa
The National Hospital for Neurology & Neurosurgery
London, , United Kingdom
Countries
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References
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Tfelt-Hansen P, Block G, Dahlof C, Diener HC, Ferrari MD, Goadsby PJ, Guidetti V, Jones B, Lipton RB, Massiou H, Meinert C, Sandrini G, Steiner T, Winter PB; International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia. 2000 Nov;20(9):765-86. doi: 10.1046/j.1468-2982.2000.00117.x. No abstract available.
Lauritzen M. Pathophysiology of the migraine aura. The spreading depression theory. Brain. 1994 Feb;117 ( Pt 1):199-210. doi: 10.1093/brain/117.1.199.
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.
Goadsby PJ, Ferrari MD, Csanyi A, Olesen J, Mills JG; Tonabersat TON-01-05 Study Group. Randomized, double-blind, placebo-controlled, proof-of-concept study of the cortical spreading depression inhibiting agent tonabersat in migraine prophylaxis. Cephalalgia. 2009 Jul;29(7):742-50. doi: 10.1111/j.1468-2982.2008.01804.x. Epub 2009 Feb 13.
Other Identifiers
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TON/01/05-CLIN
Identifier Type: -
Identifier Source: org_study_id