effects of propranolol and levetiracetam to prevent migraine attacks in children 5-15 year-old children

Clinical trial of comparison of the effects of propranolol and levetiracetam to prevent migraine attacks in 5-15 year-old children

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090412001808N5

Enrollment

Registered

2018-03-22

Start date

2018-03-20

Completion date

Unknown

Last updated

2018-03-26

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: Intervention group: In the intervention group, the Levetirastam tablet with brand name of Levebel made by Koobl Daroo Co. at a daily dose of 20 mg/kg is prescribed for 3 months. Interv

Eligibility

Sex/Gender

All

Age

5 Years to 15 Years

Inclusion criteria

Inclusion criteria: Age 5 to 15 years migraine attacks headache more than once a week Headache causing a child's disability (PedMIDAS score more than 20) Headache prophylaxis is required in the child

Exclusion criteria

Exclusion criteria: Underlying diseases such as asthma, liver disease, diabetes Secondary headaches or other neurological disorders such as epilepsy receiving medications for migraine over the past two months History of sensitivity to propranolol and levetiracetam history of propranolol and levetiracetam for migraine prophylaxis renal dysfunction

Design outcomes

Primary

Measure	Time frame
Headache severity. Timepoint: The beginning of the study, the 3rd month and the 6th month. Method of measurement: Visual Analogue Scales (From a score of 1-10 that is scored by the child).;Headache duration. Timepoint: The beginning of the study, the 3rd month and the 6th month. Method of measurement: minute.	—

Secondary

Measure	Time frame
Number of migraine attacks per month. Timepoint: The beginning of the study, the 3rd month and the 6th month. Method of measurement: Number in the questionnaire.;Side effects of medication (Dizziness, drowsiness, weight loss, anorexia, memory impairment, imbalance, skin complications). Timepoint: The 3rd month and 6th month. Method of measurement: Questionnaire.;Severity of disability due to headache. Timepoint: The beginning of the study, the 3rd month and the 6th month. Method of measurement: Questionnaire (Grade 1: Score 0-10, Grade 2: Score 11-30, Grade 3: Score 31-50 and Grade 4: Scores above 50).	—

Measure

Time frame

Number of migraine attacks per month. Timepoint: The beginning of the study, the 3rd month and the 6th month. Method of measurement: Number in the questionnaire.;Side effects of medication (Dizziness, drowsiness, weight loss, anorexia, memory impairment, imbalance, skin complications). Timepoint: The 3rd month and 6th month. Method of measurement: Questionnaire.;Severity of disability due to headache. Timepoint: The beginning of the study, the 3rd month and the 6th month. Method of measurement: Questionnaire (Grade 1: Score 0-10, Grade 2: Score 11-30, Grade 3: Score 31-50 and Grade 4: Scores above 50).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShiva Shadani

Sari University of Medical Sciences

shiva_shadani@yahoo.com+98 11 3334 2334

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026