evetiractem for the prophylactic treatment of pediatric migraine

Phase 2

Conditions: migraine headache.
migraine without aura or clasic migraine

Registration Number: IRCT2017021632603N1

Lead Sponsor: Vice chancellor for research, Tehran university of medical sciense

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 68

Inclusion Criteria

Children aged 4-17 years
met the diagnostic criteria for pediatric migraine (with or without aura) as defined by the International Headache Society
having at least 4 migraineous episodes per month or have severe disabling or intolerable headache

Exclusion Criteria

History of cluster headache, hemiplegic migraine, or chronic daily headaches
Headaches related to structural brain lesions
Presence of focal neurologic deficit
No therapeutic response with at least 3 adequate trials of medication for headache prophylaxis
History of levetiracetam sensitivity
Pregnancy
Other neurological conditions (e.g. epilepsy)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Migraine frequency. Timepoint: before initiation of trial and then per 4 weeks. Method of measurement: Headache frequency was defined as the number of attacks that fulfilled the International Headache Society criteria. In each arm, we obtained the mean number of these episodes every 4 weeks after initiation of treatment.;Migraine intensity. Timepoint: before initiation of trial and then per 4 weeks. Method of measurement: visual analogue scale (VAS).

Secondary Outcome Measures

Name	Time	Method
Efficacy (More than 50% responder rate). Timepoint: Baseline and the last 4 weeks of double-blind phase. Method of measurement: For this purpose we used headache diary so the migraine frequency of baseline phase and the last 4 weeks of double-blind phase were achieved. >50% responder rate shows the efficacy of levetiracetam and placebo in the prevention of migraine. In fact, The drug was effective if it could decrease the migraine frequency by more than 50% in double-blind phase compared with the baseline frequency. ?.;Side effects. Timepoint: monthly visits and immediately after occurence of alarms. Method of measurement: Taking history.