Comparison the Effect of Cinnarizine and Amitriptyline in Pediatric Migraine

Comparison the Effect of Cinnarizine and Amitriptyline in Pediatric Migraine Prophylaxis of Children Referring to Children Medical Center Hospital: a Randomized Clinical Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191112045413N1

Enrollment

Registered

2020-01-24

Start date

2019-12-06

Completion date

Unknown

Last updated

2020-02-24

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

Conditions

?????. Migraine

Interventions

Intervention 1: First Intervention group: patients receiving Cinnarizine 25 mg, start with one half of tablet each night and after 10 days, increase to one complete tablet each night, for 3 consecutiv

Eligibility

Sex/Gender

All

Age

4 Years to 18 Years

Inclusion criteria

Inclusion criteria: Having experienced one or more migraine attacks per month or severe dysfunction in daily and school activities

Exclusion criteria

Exclusion criteria: Use of prophylactic migraine therapy in at least one previous month Focal Neurologic Deficit Known concomitant serious diseases (hepatic, renal, etc)

Design outcomes

Primary

Measure	Time frame
Percent of patients who the severity of their headache episodes decreased to less than 50% of baseline. Timepoint: One month before to 3 months after initiation of treatment. Method of measurement: Visual Analogue Scale and Visual Pain Scale.;Percent of patients who the frequency of their headache episodes decreased to less than 50% of baseline. Timepoint: One month before to 3 months after initiation of treatment. Method of measurement: By charting all the headache episodes by detail in the special checklist.;Percent of patients who the duration of their headache episodes decreased to less than 50% of baseline. Timepoint: One month before to 3 months after initiation of treatment. Method of measurement: By charting all the headache episodes by detail in the special checklist.	—

Measure

Time frame

Percent of patients who the severity of their headache episodes decreased to less than 50% of baseline. Timepoint: One month before to 3 months after initiation of treatment. Method of measurement: Visual Analogue Scale and Visual Pain Scale.;Percent of patients who the frequency of their headache episodes decreased to less than 50% of baseline. Timepoint: One month before to 3 months after initiation of treatment. Method of measurement: By charting all the headache episodes by detail in the special checklist.;Percent of patients who the duration of their headache episodes decreased to less than 50% of baseline. Timepoint: One month before to 3 months after initiation of treatment. Method of measurement: By charting all the headache episodes by detail in the special checklist.

—

Secondary

Measure	Time frame
Quality of life scoring. Timepoint: One month before to 3 months after initiation of treatment. Method of measurement: PedMIDAS questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrnaz Olfat

Tehran University of Medical Sciences

olfat.mehrnaz@gmail.com+98 21 7703 7596

Outcome results

None listed

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