NCT05759845

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

March 8, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

February 26, 2023

Last Update Submit

February 26, 2023

Conditions

Migraine

Outcome Measures

Primary Outcomes (4)

  • reduction of headache frequency

    measured by counting

    3 months from starting drug

  • reduction of headache severity

    measured by VAS

    3 months from starting drug

  • reduction of headache duration

    measured by time in hours

    3 months from starting drug

  • improvement of headache impact

    (using HIT-6 scoring)

    3 months from starting drug

Study Arms (3)

topiramate group

ACTIVE COMPARATOR

50 patients will take topiramate

Drug: Topiramate 25Mg Tab

amitriptyline group

ACTIVE COMPARATOR

50 patients will take amitriptyline

Drug: Amitriptyline 25 Mg Oral Tablet

combination group

ACTIVE COMPARATOR

50 patients will take topiramate plus amitriptyline

Drug: topiramate 25mg plus amitriptyline 25mg

Interventions

Topiramate 25Mg TabDRUG

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

topiramate group
Amitriptyline 25 Mg Oral TabletDRUG

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

amitriptyline group
topiramate 25mg plus amitriptyline 25mgDRUG

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

combination group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of migraine (with or without aura) according to the IHS criteria (3rd edition).
  • Experienced long lasting and frequent (≥2) migraine attacks per month (EFNS guideline,2009) and impaired quality of life.
  • Age at entry 18-50 years.
  • Willing to participate and give informed written consent.
  • Patients not on other prophylactic medication of migraine.

You may not qualify if:

  • Age \< 18 years, \>50 years
  • Suffering from headaches other than migraine.
  • Patients with serious medical conditions such as Cardiovascular Diseases, Glaucoma, Liver or Kidney Diseases, Malignancy, BEP.
  • Pregnant, lactating mother.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dhaka Medical College

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

TopiramateAmitriptylineTablets

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetosesDibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsDosage FormsPharmaceutical Preparations

Study Officials

  • Kazi Gias Uddin Ahmed, FCPS, MD

    Dhaka Medical College

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This single center, open label clinical trial will be conducted on total 150 patients with migraine .They will be subdivided into three group,50 patients in each group, randomized in 1:1:1 format. group A 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
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 26, 2023

First Posted

March 8, 2023

Study Start

August 22, 2022

Primary Completion

February 28, 2023

Study Completion

May 31, 2023

Last Updated

March 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)