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Levetiracetam in migraine headaches of children

A comparative study on the efficacy of levetiracetam and amitriptyline in childhood migraine; An open-label randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20171212037850N1
Enrollment
60
Registered
2018-05-01
Start date
2018-02-04
Completion date
Unknown
Last updated
2018-05-21

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:Levetiracetam with a starting dose of 10 mg / kg given at a dose of 20 mg / kg in a week. In children and adults, the maximum dose is 3000 mg per day before bedtime,

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 15 Years

Inclusion criteria

Inclusion criteria: All of children with migraine headache with or without aura, at least two attack per week or four attack per month, so that the attacks cause them to consume the analgesics or interfere with everyday activities

Exclusion criteria

Exclusion criteria: Epilepsy Complicated migraine Not having the ability to record data related to the number, duration, and severity of headaches Use of other prophylactic drugs other than Levetiracetam and Amitriptyline Severe psychiatric problems like depression and ADHD Hypersensitivity to tricyclic anti depressants drugs Taking analgesic more than 4 times a week for migraine headache

Design outcomes

Primary

MeasureTime frame
Duration of headache. Timepoint: Before, one month later, two months later and three months after treatment began. Method of measurement: Daily Headache Registration Form.;Headache severity. Timepoint: Before, one month later, two months later and three months after treatment began. Method of measurement: Wong-Baker FACES Pain Rating Scale.;Headache frequency. Timepoint: Before, one month later, two months later and three months after treatment began. Method of measurement: Record daily diary of headache.;Improving the quality of life. Timepoint: Before, one month later, two months later and three months after treatment began. Method of measurement: PedMIDAS quality of life checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGholamreza Jelodar

Esfahan University of Medical Sciences

jelodar-g@ajums.ac.ir+98 31 3421 8176

Outcome results

None listed

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