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Evaluation of the effectiveness of Cyproheptadine on paroxysmal short-time headache in children

Evaluation of the effectiveness of Cyproheptadine on paroxysmal short-time headache in children between 2 to 15 years of age: A single-arm clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190208042654N5
Enrollment
20
Registered
2022-02-22
Start date
2022-04-04
Completion date
Unknown
Last updated
2022-03-08

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

Conditions

Episodic Paroxysmal hemicrania. Episodic paroxysmal hemicrania

Interventions

Intervention group: Cyproheptadine 0.2 to 0.4 mg per kg bodyweight of the child is given in two divided doses for the child. Cyproheptadine is available in the form of 4 mg tablets and 2 mg syrup in 5

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 15 Years

Inclusion criteria

Inclusion criteria: Children with 2 to 15 years of age Children with episodic paroxysmal hemicrania referred to neurology clinic whose disease has been definitively diagnosed according to the ICHD criteria. Number of attacks of equal or more than once a week

Exclusion criteria

Exclusion criteria: Patients' unwillingness to cooperate during the study Severe and uncontrollable side effects of cyproheptadine If, based on possible laboratory or imaging findings, a diagnosis other than episodic paroxysmal hemicrania is made during the study Epilepsy or epileptic headaches Existence of structural anomalies in MRI imaging History of allergies to similar drugs Inability to record data on the number, duration, and severity of headaches Taking a prophylactic drug other than Cyproheptadine Severe psychiatric problems such as depression or ADHD

Design outcomes

Primary

MeasureTime frame
Frequency, duration, and severity of headache attacks and drug side effects. Timepoint: before intervention and each month after intervention. Method of measurement: Checklist includes measuring the number of attacks per week, the duration of attacks in form of minutes and its severity according to the VAS criteria and the occurrence of known side effects.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJafar Nasiri

Esfahan University of Medical Sciences

Nasiri.jafar@gmail.com+98 31 3386 6266

Outcome results

None listed

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