Migraine with aura, ICD-10NA G43.1 MedDRA version: 14.1 Level: LLT Classification code 10027601 Term: Migraine aura System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Plactidil
Product Name: Plactidil
Pharmaceutical Form: Tablet
CAS Number: 32828-81-2
Other descriptive name: PICOTAMIDE
Pharmaceutical form of the placebo: Tablet
Route of administration o
Sponsors
Danish Headache Centre, Dep. of Neurology, Glostrup Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of picotamide compared to placebo in the reduction of the number of auras in patients with migraine with aura;Secondary Objective: • To compare the safety and tolerability of picotamide and placebo in the prophylactic treatment of patients with migraine with aura. • To investigate the efficacy of picotamide compared to placebo on the number and overall severity of migraine attacks experienced during a three month treatment period together with associated symptoms. ;Timepoint(s) of evaluation of this end point: During treatment patients will complete a daily diary card, which will be considered as source efficacy documentation. The patient wil be Adverse events, use of concomitant medication and compliance with trial medication will be monitored throughout the trial. Diary cards, CRF and notes in the hospital journals/files of the patients will constitute the source data. Assesment plan: Screening and randomisation (visit1) Clinic assessment week 4 (visit 2) Telephone contact week 8 Clinic assessment weeks 12 and 16 (visits 2 and 3) Telephone contact week 18.5 Clinic assessment week 20 (visit 4) Telephone contact week 24 Clinic assessment week 28 (visit 5) Follow-up assessment Post study treatment ;Primary end point(s): • To investigate the efficacy of picotamide compared to placebo in the reduction of the number of auras in patients with migraine with aura. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To compare the safety and tolerability of picotamide and placebo in the prophylactic treatment of patients with migraine with aura. • To investigate the efficacy of picotamide compared to placebo on the number and overall severity of migraine attacks experienced during a three month treatment period together with associated symptoms. Secondary efficacy variables: 1. Mean number of migraine headache days during each treatment period. 2. Mean number of headache days in each treatment period. 3. Mean number of auras followed by headache in each treatment period. 4. Mean number of headache days in each month of treatment in each treatment period. 5. Mean number of auras and/or migraine headache during each treatment period. 6. Mean number of migraine headache attacks in each treatment period. 7. Mean monthly consumption of rescue medication during the last month and the whole of each treatment period from the baseline period to Month 3. 8. Mean duration of auras in each treatment period. 9. Mean number of symptoms associated with auras in each treatment period. 10. Number of patients in the picotamide treatment group documented to have =50% reduction in the number of auras and the number of migraine headache days relative to the placebo treatment period; number of patients in both treatment groups defined as a responder relative to a historical baseline. Safety variables: Incidence of all adverse events (AEs), serious AEs and AEs leading to withdrawal of trial medication, clinical laboratory tests, vital signs and physical examination. ;Timepoint(s) of evaluation of this end point: During treatment patients will complete a daily diary card, which will be considered as source efficacy documentation. The patient wil be Adverse events, use of concomitant medication and compliance with trial medication will be monitored throughout the trial. Diary cards, CRF and notes in the hospital journals/files of the patients will constitute the sourc | — |
Countries
Denmark, Hungary
Outcome results
None listed