Multi-centre, parallel group, double-blind, placebo controlled study of the efficacy and tolerability of TONABERSAT in prophylaxis of migraine headache
- Conditions
- Migraine with or without aura meeting the diagnostic criteria of the International Classification of Headache Disorders (Edition 2).
- Registration Number
- EUCTR2005-004835-23-HU
- Lead Sponsor
- Minster Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 128
1.Male or female patients between 18 and 55 years of age; women of childbearing potential must be using a reliable form of contraception for at least three months prior to enrolment and have a negative pregnancy test at screening.
2.Patients should have 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 – Edition 2 (Appendix 3) 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Patients with a diagnosis of migraine according to the diagnostic criteria of the International Classification of Headache Disorders – Edition 2 (Appendix 3) at age 50 years or more.
2.Experience headache other than migraine more than once a month.
3.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.
4.Patients with other significant central nervous system disorders in the opinion of the investigator.
5.Failure to respond to no more than two adequately dosed (i.e. recommended total daily dose and of sufficient duration) migraine prophylactic medications.
6.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.
7.Prophylactic treatment within two months prior to entry to the trial.
8.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. tizanadine) and the new generation antipsychotics (e.g. olanzapine) currently or within the previous 2 months should also be excluded.
9.Patients who, in the opinion of the investigator, have significant cerebrovascular disease, e.g. transient ischaemic attacks, stroke.
10.Patients who, in the opinion of the investigator, have clinically significant cardiovascular disease.
11.Patients suffering from a current clinical diagnosis of major depressive disorder or schizophrenia.
12.Patients with renal dysfunction, defined as a serum creatinine of greater than 125% of the upper limit of normal for their age group.
13.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.
14.Patients with known alcohol or other substance abuse.
15.Failure to complete the diary card during the screening period.
16.Participation in another clinical trial in the previous four weeks.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the efficacy and tolerability of tonabersat compared to placebo in the prophylaxis of migraine headache;Secondary Objective: ;Primary end point(s): Primary efficacy variable: Change in the mean monthly number of migraine headache days from the baseline period to Month 3.<br>
- Secondary Outcome Measures
Name Time Method