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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05759845
Other study ID # ERC-DMC/ECC/2022/140
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date August 22, 2022
Est. completion date May 31, 2023

Study information

Verified date February 2023
Source Dhaka Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 150
Est. completion date May 31, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Topiramate 25Mg Tab
topiramate 25mg daily for 7 days followed by 25mg twice daily for 11 weeks
Amitriptyline 25 Mg Oral Tablet
Amitriptyline 10 Mg Oral Tablet daily for 7 days followed by 25mg daily for 11 weeks
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

Locations

Country Name City State
Bangladesh Dhaka Medical College Dhaka

Sponsors (1)

Lead Sponsor Collaborator
Dr. Reaz Mahmud

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type Measure Description Time frame Safety issue
Primary reduction of headache frequency measured by counting 3 months from starting drug
Primary reduction of headache severity measured by VAS 3 months from starting drug
Primary reduction of headache duration measured by time in hours 3 months from starting drug
Primary improvement of headache impact (using HIT-6 scoring) 3 months from starting drug
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