Amitriptyline and melatonin in prophylaxis of of migraine in children

Comparison of efficacy of amitriptyline and melatonin in prophylaxis of headach in 5-15 year old migraineurs children

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201305292639N12

Enrollment

Registered

2013-06-07

Start date

2013-06-09

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Migraine headache. Migraine without aura [common migraine

Interventions

Intervention 1: single dose of 1mg/kg/day of amitriptyline at bed time for three months. Intervention 2: single dose of 0.3mg/kg/day of melatonine at bed time for three months.

Prevention

single dose of 1mg/kg/day of amitriptyline at bed time for three months

single dose of 0.3mg/kg/day of melatonine at bed time for three months

Eligibility

Sex/Gender

All

Age

5 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. children aged 5-15 years 2. Having migraine headache based on International Headache Society Criteria 3. Having frequent ( one or more headache attack per week ) or disabling ( PedMIDAS more than 20) headaches that prophylactic therapy indicated in them . in one month 4. not used any migraine preventive therapy Exclusion Criteria: 1. History of drug allergy 2. Secondary headaches such as epilepsy or other neurologic disorders 3. Systemic diseases such as asthma, diabetes mellitus , metabolic acidosis , renal stone and hepatic diseases

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Monthly frequency of headache. Timepoint: before and three months after treatment. Method of measurement: asking from patient.;Severity of headache. Timepoint: before and three months after treatment. Method of measurement: asking from patient.;Duration of headache. Timepoint: before and three months after treatment. Method of measurement: asking from patient.;Pediatric Migraine Disability score. Timepoint: before and three months after treatment. Method of measurement: asking from patient.	—

Measure

Time frame

Monthly frequency of headache. Timepoint: before and three months after treatment. Method of measurement: asking from patient.;Severity of headache. Timepoint: before and three months after treatment. Method of measurement: asking from patient.;Duration of headache. Timepoint: before and three months after treatment. Method of measurement: asking from patient.;Pediatric Migraine Disability score. Timepoint: before and three months after treatment. Method of measurement: asking from patient.

—

Secondary

Measure	Time frame
Side effects. Timepoint: monthly until three months after treatment. Method of measurement: clinical exam and asking from patients.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.razieh Fallah

Shahid Sadoughi University of Medical Sciences, Yazd, Iran

FALLAH@ssu.ac.ir+98 35 1822 4000

Outcome results

None listed

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