NCT06158230

Comparison of Efficacy Between Combination of Amitriptyline-propranolol and Pizotifen for Migraine Prophylaxis.

Comparison of Efficacy Between Combination of Amitriptyline-propranolol and Pizotifen for Migraine Prophylaxis: A Single-blind Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to compare efficacy and observe common adverse effects of a combination of amitriptyline-propranolol and pizotifen as prophylactic treatments for migraine. The main question it aims to answer is: • Does pizotifen more effective than the combination of amitriptyline-propranolol in migraine prophylaxis? Participants will be asked to : * Maintain the provided headache diary accordingly * Take supplied drugs as described during clinical visits * Contact principle investigator if there is any issues regarding drug use and/or their adverse effects

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Pizotifen	Pizotifen will be given only at night time to avoid daytime somnolence. Starting dose will be 0.5mg then gradually increased to 1.5 mg
DRUG	Amitriptyline-propranolol	Amitriptyline will be given at bedtime only, starting at 10 mg daily and gradually increasing to 25 mg daily. Propranolol will be started in 40 mg daily in divided doses, which gradually increases to 80 mg daily in divided doses

Timeline

• Start date: 2023-03-19
• Primary completion: 2023-11-25
• Completion: 2024-01-15
• First posted: 2023-12-06
• Last updated: 2023-12-06

Locations

1 site across 1 country: Bangladesh