Clinical trial NCT00332007 (phase 2, status: completed)
Conditions: migraine with aura
ICD codes: G43.111, G43.011, G43.119, G43.101, G43.001, G43.109, G43.711
Drugs: tonabersat, placebo
SMILES: CC(=O)C1=CC=C2OC(C)(C)[C@@H](O)[C@@H](NC(=O)C3=CC=C(F)C(Cl)=C3)C2=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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
             (defined in the protocol) for at least 3 months prior to enrolment and they must have
             a negative pregnancy test at screening with no intention of becoming pregnant during
             the study period

        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

          -  Patients with known alcohol or other substance abuse

          -  Use of an investigational drug (for any indication) within 30 days or 5 half-lives,
             whichever is the longer, prior to screening

          -  Women who are pregnant or breast feeding

          -  Women of childbearing potential not using a reliable form of contraception

          -  Patients with any other clinically significant condition which, in the investigators
             opinion, would render them unsuitable for this study