Topiramate, Amitriptyline Monotherapy and Combination Therapy in Migraine Prophylaxis

NCT ID: NCT05759845

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-22
• Study Completion Date: 2023-05-31

Brief 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.

Detailed Description

Background: Migraine is a common headache that can significantly impair the lives of otherwise normally functioning people. Several drugs are used individually for migraine prophylaxis, all of which have varying degrees of adverse effects, that may significantly limit their use. There is a need for effective, well tolerated and affordable drug for chronic migraine prophylaxis either alone or in combination in low socioeconomic countries.

To study and compare the efficacy and safety of Topiramte ,Amitrptyline monotherapy and combination therapy as prophylactic treatment in migraine patients .This single center, open label clinical trial will be conducted in Dhaka medical college and hospital . Patients who matches the inclusion and exclusion criteria will be enrolled in the study after taking written informed consent from all who agrees to participate. Migraine will be diagnosed according to the criteria of the Headache Classification Committee of the International Headache Society (3rd edition). After enrollment Simple random sampling will be done by parallel design as 1:1:1. Total 150 patients with migraine will be subdivided into three group: group A (n=50) will be treated with Topiramate and group B (n=50) with Amitriptyline and group C (n=50) with Topiramate plus Amitriptyline combination . Topiramate will be given to group A as 25 mg daily for first week ,then 25 mg twice daily till the end of the study. Group B will receive Amitriptyline 10mg daily for first week then 25mg daily till the end of the study. Group C will receive Topiramate 25 mg daily plus Amitrityline 10mg daily for first week then Topiramate 25 mg twice daily plus Amitrityline 25mg daily till the end of the study. Day 1 will be date of randomization and taking drug. Frequency, severity ,duration of headache and headache impact severity will be recorded at the biginning of study and end of 8 weeks and 12 weeks of treatment period. The patients will maintain a headache diary during the whole period. Information on demographic characteristics and migraine symptoms ,signs will be collected by a structured questionnaire .The evaluation of the treatment at the end of 8 weeks and 12 weeks of treatment period will be done by direct or telephonic interview . The outcome measures will be reduction of headache frequency and severity (using visual analogue scale of pain), duration of headache and improvement of headache impact (using HIT-6 scoring). Throughout the study, patients will be monitored for any symptoms or signs of adverse effects.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

topiramate group

50 patients will take topiramate

Group Type: ACTIVE_COMPARATOR

Topiramate 25Mg Tab

Intervention Type: DRUG

topiramate 25mg daily for 7 days followed by 25mg twice daily for 11 weeks

amitriptyline group

50 patients will take amitriptyline

Group Type: ACTIVE_COMPARATOR

Amitriptyline 25 Mg Oral Tablet

Intervention Type: DRUG

Amitriptyline 10 Mg Oral Tablet daily for 7 days followed by 25mg daily for 11 weeks

combination group

50 patients will take topiramate plus amitriptyline

Group Type: ACTIVE_COMPARATOR

topiramate 25mg plus amitriptyline 25mg

Intervention Type: DRUG

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

Interventions

Topiramate 25Mg Tab

topiramate 25mg daily for 7 days followed by 25mg twice daily for 11 weeks

Intervention Type: DRUG

Amitriptyline 25 Mg Oral Tablet

Amitriptyline 10 Mg Oral Tablet daily for 7 days followed by 25mg daily for 11 weeks

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of migraine (with or without aura) according to the IHS criteria (3rd edition).

2. Experienced long lasting and frequent (≥2) migraine attacks per month (EFNS guideline,2009) and impaired quality of life.

3. Age at entry 18-50 years.

4. Willing to participate and give informed written consent.

5. Patients not on other prophylactic medication of migraine.

Exclusion Criteria

1. Age < 18 years, >50 years

2. Suffering from headaches other than migraine.

3. Patients with serious medical conditions such as Cardiovascular Diseases, Glaucoma, Liver or Kidney Diseases, Malignancy, BEP.

4. Pregnant, lactating mother.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Reaz Mahmud

OTHER

Sponsor Role: lead

Responsible Party

Dr. Reaz Mahmud

Assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kazi Gias Uddin Ahmed, FCPS, MD

Role: STUDY_DIRECTOR

Dhaka Medical College

Locations

Dhaka Medical College

Dhaka, , Bangladesh

Countries

Bangladesh

Other Identifiers

ERC-DMC/ECC/2022/140

Identifier Type: -

Identifier Source: org_study_id