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Search / Trial NCT06158230

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

Launched by BANGABANDHU SHEIKH MUJIB MEDICAL UNIVERSITY, DHAKA, BANGLADESH · Nov 27, 2023

Trial Information

Current as of July 23, 2025

Active, not recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two different treatments for preventing migraines. Researchers want to find out if a combination of two medications, amitriptyline and propranolol, is less effective than another medication called pizotifen in stopping migraines before they start. Participants in the study will need to keep a diary to track their headaches and take the medications as instructed during their visits. They’ll also need to reach out to the study leader if they have any questions or experience side effects from the medications.

To be eligible for this trial, participants must be between 18 and 50 years old and have a diagnosis of migraines, but not other types of headaches. They should not be currently taking any migraine prevention medications and must be willing to participate fully. It’s important that they can accurately fill out the headache diary. The trial is currently active but not looking for new participants at this time. If you or someone you know is considering participation, it’s a good opportunity to help find better ways to manage migraine symptoms.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Patient of migraine (with typical aura or without aura) according to ICHD-3 (International Classification of Headache Disorder, 3rd edition) criteria.
  • 2. Age at entry: 18 to 50 years (to minimize the risks related to adverse effects of study drugs such as drowsiness, weight gain, A-V conduction block, postural hypotension)
  • 3. Patients not on any prophylactic medications.
  • 4. Patients willing to take part in the study.
  • 5. Patients being able to fill a headache diary successfully \& reliably.
  • Exclusion Criteria:
  • 1. Age \<18 years or \>50 years
  • 2. Patients having headache other than migraine, complicated migraine, ophthalmoplegic migraine, catamenial migraine, basilar migraine.
  • 3. Patients on prophylactic medication.
  • 4. Co-morbidities such as heart failure, hepatic or renal impairment, diabetes, bronchial asthma, malignancy, intracranial vascular aneurysm, pregnancy \& breastfeeding etc.
  • 5. Patients having known hypersensitivity to amitriptyline, propranolol or pizotifen

About Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Bangabandhu Sheikh Mujib Medical University (BSMMU) in Dhaka, Bangladesh, is a premier institution dedicated to advancing medical education, research, and healthcare services. As a leading clinical trial sponsor, BSMMU is committed to fostering innovative research initiatives that enhance patient care and contribute to the global medical community. The university boasts a multidisciplinary team of experts and state-of-the-art facilities, enabling the conduct of rigorous clinical trials across various therapeutic areas. With a focus on ethical standards and patient safety, BSMMU aims to facilitate the development of new treatments and improve health outcomes both locally and internationally.

Locations

Dhaka, , Bangladesh

Patients applied

0 patients applied

Trial Officials

Kanuj Kumar, MD

Study Chair

Professor

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported