Clinical trial NCT00311662 (phase 2, status: completed)
Conditions: migraine without aura, 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:

          -  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, 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.

          -  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:

          -  Patients with a diagnosis of migraine according to the diagnostic criteria of the
             International Classification of Headache Disorders at age 50 years or more.

          -  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.