E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Migraine with aura meeting the diagnostic criteria of the International Classification of Headache Disorders (Edition 2) |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the efficacy of tonabersat compared to placebo in the reduction of the number of aura attacks and the number of migraine headache days in patients with migraine with aura
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E.2.2 | Secondary objectives of the trial |
To compare the safety and tolerability of tonabersat and placebo in the prophylactic treatment of patients with migraine with aura
To investigate the efficacy of tonabersat compared to placebo on the number and overall severity of migraine attacks experienced during a three month treatment period together with associated symptoms
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 for at least 3 months prior to enrolment.
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E.4 | Principal 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
•Women who are pregnant or breast feeding
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E.5 End points |
E.5.1 | Primary end point(s) |
•Difference in the mean number of aura attacks experienced between treatment groups
•Difference in the mean number of migraine headache days between treatment groups
Safety variables include incidence of all adverse events (AEs), serious AEs and AES leading to withdrawal of trial medication, clinical laboratory tests, vital signs and physical examination
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 20 |
E.8.9.1 | In the Member State concerned days | |