migraine. migraine
Conditions
Interventions
Intervention 1: cinnarizine tablet 0.6 - 1.5 mg/kg for patient weight under 30 kg and 50mg daily for patient greater than 30kg (3 months ) . Intervention 2: placebo tablet 0.6 - 1.5 mg/kg for patient
Prevention
Placebo
cinnarizine tablet 0.6 - 1.5 mg/kg for patient weight under 30 kg and 50mg daily for patient greater than 30kg (3 months ) .
placebo tablet 0.6 - 1.5 mg/kg for patient weight under 30kg and 50mg for patient greater than 30kg ,daily, (3 months )
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
5 Years to 17 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Patients with migraine (with or without aura), diagnosed according to the International Headache society criteria. 2. Patients who had one or more migraine attack per week ; or sever dysfunction in daily and school activities during prospective baseline phase. 3. Headaches must not relate to any known structural brain lesion or other systemic conditions. Exclusion criteria: 1. Chronic headache, complications of migraine or other migraine variant. 2. Children and adolescents with Focal neurologic deficit. 3. History of diagnosed sensitivity to cinnarizine . 4. Patients who showed sever adverse effect to the study treatment drugs (in the double-blind phase of the study). 5. Serious comorbidities (hepatic, renal, cardiovascular or thyroid disease). 6. Patients who took prophylactic therapy for migraine within 4 weeks before study.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of headache. Timepoint: monthly. Method of measurement: questionnaire.;Severity of headache. Timepoint: monthly. Method of measurement: questionnaire( VAS).;Duration of attack. Timepoint: monthly. Method of measurement: questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects of cinnarizine. Timepoint: each time during the study. Method of measurement: ask from participants and parents. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Soodeh Salehi
Tehran University of Medical Sciences
Outcome results
None listed