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Comparison of two drugs in prevention of childhood migraine

Flunarizine versus propranolol in prophylaxis of pediatric migraine : an open labelled trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/039008
Enrollment
40
Registered
2021-12-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: - Health Condition 2: G438- Other migraine

Interventions

Intervention1: compare the efficacy of Propranalol and Flunarizine for prophylaxis in pediatric migraine: The ones fulfilling the inclusion criteria after the prospective period will be enrolled into

Sponsors

Pandit BDSharma UHSRPGIMS ROHTAK
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 7 to 14 years with migraine with a score of 11 to 139 on Pediatric migraine Disability Assessment Score(PedMIDAS) and a headache frequency of 4 or more days per month over a baseline period of 28 days.

Exclusion criteria

Exclusion criteria: Children with either of the following conditions will be excluded chronic liver disease, chronic kidney disease, hypertension (BP >95TH percentile for age, sex, and height; or 130/80 mm hg for age >13yr) diabetes, (fasting plasma glucose 126 mg/dl or 2hr plasma glucose during OGTT 200 mg/dl) epilepsy, Obesity (BMI >95th percentile for age and sex) Asthma

Design outcomes

Primary

MeasureTime frame
The primary outcome will be proportion of children with a relative reduction of 50% or more in the number of headache days in comparison of 28 day baseline period with the last 28 days of 12 week trial period.Timepoint: 16 weeks

Secondary

MeasureTime frame
To compare headache disability,absolute reduction in number of headache days and the safety of Propranalol and Flunarizine in prophylaxis of pediatric migraineTimepoint: 16 weeks

Countries

India

Contacts

Public ContactDr Preet

Pt. B.D. Sharma PGIMS Rohtak

ndvaswani@hotmail.com9034428284

Outcome results

None listed

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