Overview

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

Status:
Active, not recruiting
Trial end date:
2024-01-15
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Treatments:
Amitriptyline
Propranolol
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