Status:
UNKNOWN
Comparison of Efficacy Between Combination of Amitriptyline-propranolol and Pizotifen for Migraine Prophylaxis.
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Conditions:
Migraine
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- Patient of migraine (with typical aura or without aura) according to ICHD-3 (International Classification of Headache Disorder, 3rd edition) criteria.
- 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)
- Patients not on any prophylactic medications.
- Patients willing to take part in the study.
- Patients being able to fill a headache diary successfully \& reliably.
Exclusion
- Age \<18 years or \>50 years
- Patients having headache other than migraine, complicated migraine, ophthalmoplegic migraine, catamenial migraine, basilar migraine.
- Patients on prophylactic medication.
- Co-morbidities such as heart failure, hepatic or renal impairment, diabetes, bronchial asthma, malignancy, intracranial vascular aneurysm, pregnancy \& breastfeeding etc.
- Patients having known hypersensitivity to amitriptyline, propranolol or pizotifen
Key Trial Info
Start Date :
March 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2024
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06158230
Start Date
March 19 2023
End Date
January 15 2024
Last Update
December 6 2023
Active Locations (1)
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1
Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh, 1200