Topiramate, Amitriptyline Monotherapy and Combination Therapy in Migraine Prophylaxis
NCT05759845 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2023-03-08
Summary
The goal of this clinical trial is to compare the efficacy and safety of Topiramate, Amitriptyline Monotherapy and Combination Therapy in Migraine Prophylaxis in outddor migraine patients attending headache clinic. The main question it aims to answer is whether there is any difference between the efficacy of Topiramate, Amitriptyline monotherapy and combination therapy in migraine prophylaxis. Participants will take Topiramate, Amitriptyline Monotherapy and Combination Therapy and maintain a headache diary. Researchers will compare Topiramate, Amitriptyline Monotherapy and Combination Therapy groups to see if there is any differences in efficacy and safety.
Conditions
Interventions
- DRUG
-
Topiramate 25Mg Tab
topiramate 25mg daily for 7 days followed by 25mg twice daily for 11 weeks
- DRUG
-
Amitriptyline 25 Mg Oral Tablet
Amitriptyline 10 Mg Oral Tablet daily for 7 days followed by 25mg daily for 11 weeks
- DRUG
-
topiramate 25mg plus amitriptyline 25mg
topiramate 25mg daily for 7 days followed by 25mg twice daily for 11 weeks with Amitriptyline 10 Mg Oral Tablet daily for 7 days followed by 25mg daily for 11 weeks
Sponsors & Collaborators
-
Dr. Reaz Mahmud
lead OTHER
Principal Investigators
-
Kazi Gias Uddin Ahmed, FCPS, MD · Dhaka Medical College
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-22
- Primary Completion
- 2023-02-28
- Completion
- 2023-05-31
Countries
- Bangladesh
Study Locations
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