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Cinnarizine and sodium valproate in prophylaxis of pediatric migraine .

The efficacy and safety of cinnarizine and sodium valproate in prophylaxis of migraine among children and adolescents aged 6 to 17: a randomized, double-blind, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201206306907N4
Enrollment
90
Registered
2012-09-15
Start date
2009-10-23
Completion date
Unknown
Last updated
2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine. Migraine

Interventions

Intervention 1: We randomly divided participants in 3 groups: cinnarizine group received one Cinnarizine tablet (37.5 mg for patients aged 6 to 11 and 50 mg for others aged 12 to 17) per day. All dru

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 17 Years

Inclusion criteria

Inclusion criteria: Patients with migraine (with or without aura), diagnosed according to the International Headache society criteria Patients who had at least four migraine attacks per 4 weeks; or sever dysfunction in daily and school activities during prospective baseline phase.

Exclusion criteria

Exclusion criteria: Chronic headache, complications of migraine or other migraine variant Children and adolescents with Focal neurologic deficit History of diagnosed sensitivity to each of drugs that used in the study Patients who took prophylactic therapy for migraine within 8 weeks before study. Headaches related to structural brain lesions Pregnancy

Design outcomes

Primary

MeasureTime frame
Frequency of headache. Timepoint: frequency of frequency of each attack in a month. Method of measurement: questionnaire.;Intensity of headache. Timepoint: intensity of each attack. Method of measurement: Visual analogue scale (VAS).

Secondary

MeasureTime frame
Adverse effects. Timepoint: in the double-blind phase of the study. Method of measurement: ask from participants and parents.;More than 50% responder rate. Timepoint: in the double-blind phase of the study and baseline. Method of measurement: ask from participants and parents.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahtab Ramezani

Tehran University of Medical Sciences

manoochehr_1993@yahoo.com+98 21 6693 5848

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 20, 2026