MedTrace Logo

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

NCT06158230 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-12-06

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Principal Investigators

  • Kanuj Kumar, MD · Professor

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-19
Primary Completion
2023-11-25
Completion
2024-01-15

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06158230 on ClinicalTrials.gov