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RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO COMPARE THE EFFICACY OF PROPRANOLOL WITH PLACEBO FOR THE PROPHYLAXIS OF MIGRAINE IN CHILDREN

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO COMPARE THE EFFICACY OF PROPRANOLOL WITH PLACEBO FOR THE PROPHYLAXIS OF MIGRAINE IN CHILDREN

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200621001
Enrollment
20
Registered
2020-06-21
Start date
2019-04-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Migraine without aura Migraine Propranolol Placebo

Interventions

Oral propranolol 1&#45
3 mg/kg/day in two divided doses,The placebo will be a tablet composed of an inert substance with similar physical characteristics to propranolol tablet.
Experimental Drug,Placebo Comparator Drug
Propranolol ,Placebo

Sponsors

Maulana Azad Medical College, Bahadur shah zafar marg, New Delhi.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: • Diagnosed with Migraine without aura as per International Classification of Headache Disorders, 3rd Edition (ICHD-3) (Annexure-4). • Either >3 missed school days or >3 severe headaches per month.

Exclusion criteria

Exclusion criteria: • Diagnosed with another co-existent headache disorder; • Co-existent asthma or cardiovascular disease that preclude the use of propranolol; • Receiving prophylaxis with any medication, currently or in past 3 months; • Receiving any anti-convulsant drug, currently or in past 3 months; and • Receiving Complementary and alternative medications (CAM).

Design outcomes

Primary

MeasureTime frame
Number of migraine attacks 3 months Headache diary

Secondary

MeasureTime frame
the frequency of migraine attacks 3 months manual

Countries

India

Contacts

Public ContactKeerthana Dhanapaul

Postgraduate Resident

keerthanadhanapaul@gmail.com09043708532

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026