A medical, clinical, placebo controlled trial to evaluate the effect of the drug picotamide in the prophylactic treatment of migraine with aura.

• Conditions: Migraine with aura, ICD-10NA G43.1; MedDRA version: 14.1Level: LLTClassification code 10027601Term: Migraine auraSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-006207-36-DK
• Lead Sponsor: Danish Headache Centre, Dep. of Neurology, Glostrup Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-28
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

•Patients with an established history of migraine with aura of at least one year meeting the diagnostic criteria of the International Classification of Headache Disorders – 2nd edition. Patients are required to have 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. A reliable form of contraception is defined as follows:

-oral birth control pills taken for at least three cycles prior to entering the study, continued throughout the study period and for at least one month afterwards
-an intrauterine device (IUD) inserted by a qualified clinician
-medroxyprogesterone acetate (Depo-Provera) active for at least three months prior to entering the study and with continued administration at intervals sufficient to maintain contraceptive efficacy throughout the study period and for at least one month afterwards
-sterilisation (via hysterectomy or bilateral tubal ligation)
-sterilisation of partner
-double barrier birth control (e.g. diaphragm or condom plus spermicidal gel)

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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients fulfilling any of the following contraindications for picotamide: hypersensitivity to the active substance or any excipients; hemorrhagic syndromes and peptic ulcers.

•Patients in treatment with concurrent administration of aspirin and other antiplatelet or anticoagulant drugs because of interactions.

•Patients experiencing headache other than migraine or tension type headache.

•Overuse of acute migraine treatments defined as more than 14 days per month with analgesics and more than 9 days per month of ergots or triptans within the last two months.

•Migraine prophylactic treatment within one month 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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified