MigrainePhase 4NCT05759845
Topiramate, Amitriptyline Monotherapy and Combination Therapy in Migraine Prophylaxis
A Phase 4 study testing Topiramate 25Mg Tab, Amitriptyline 25 Mg Oral Tablet and topiramate 25mg plus amitriptyline 25mg in people with Migraine, run by Dr. Reaz Mahmud at 1 site in Bangladesh.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Migraine
- What is being tested?
- Topiramate 25Mg Tab, Amitriptyline 25 Mg Oral Tablet and topiramate 25mg plus amitriptyline 25mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBangladesh
- Study dates
- 22 Aug 2022to 31 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topiramate, Amitriptyline Monotherapy and Combination Therapy in Migraine Prophylaxis: An Open Label Randomized Clinical Trial
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.
Read the 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
- Being tested
- Topiramate 25Mg Tab, Amitriptyline 25 Mg Oral Tablet, topiramate 25mg plus amitriptyline 25mg
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topiramate 25Mg TabDrug
topiramate 25mg daily for 7 days followed by 25mg twice daily for 11 weeks
Amitriptyline 25 Mg Oral TabletDrug
Amitriptyline 10 Mg Oral Tablet daily for 7 days followed by 25mg daily for 11 weeks
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
| Study group | Role | What they receive |
|---|---|---|
| topiramate group | Active comparator | 50 patients will take topiramate Receives: Drug: Topiramate 25Mg Tab |
| amitriptyline group | Active comparator | 50 patients will take amitriptyline Receives: Drug: Amitriptyline 25 Mg Oral Tablet |
| combination group | Active comparator | 50 patients will take topiramate plus amitriptyline Receives: Drug: topiramate 25mg plus amitriptyline 25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of headache frequency
measured by counting
Measured: 3 months from starting drug
reduction of headache severity
measured by VAS
Measured: 3 months from starting drug
reduction of headache duration
measured by time in hours
Measured: 3 months from starting drug
improvement of headache impact
(using HIT-6 scoring)
Measured: 3 months from starting drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start22 Aug 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Reaz Mahmud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Reaz Mahmud, Dhaka Medical College
- Investigators
- Kazi Gias Uddin Ahmed, FCPS, MD, Study director, Dhaka Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759845
- Sponsor's protocol ID
- ERC-DMC/ECC/2022/140
- Status last verified
- Feb 2023
- First submitted
- 26 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topiramate, Amitriptyline Monotherapy and Combination Therapy in Migraine Prophylaxis: An Open Label Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05759845
- Acronym / sponsor ID
- ERC-DMC/ECC/2022/140
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Dr. Reaz MahmudUniversity, hospital or other
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| topiramate group | Active comparator | Drug: Topiramate 25Mg Tab50 patients will take topiramate |
| amitriptyline group | Active comparator | Drug: Amitriptyline 25 Mg Oral Tablet50 patients will take amitriptyline |
| combination group | Active comparator | Drug: topiramate 25mg plus amitriptyline 25mg50 patients will take topiramate plus amitriptyline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topiramate 25Mg Tabtopiramate 25mg daily for 7 days followed by 25mg twice daily for 11 weeks | Drug | topiramate group |
| Amitriptyline 25 Mg Oral TabletAmitriptyline 10 Mg Oral Tablet daily for 7 days followed by 25mg daily for 11 weeks | Drug | amitriptyline group |
| topiramate 25mg plus amitriptyline 25mgtopiramate 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 | Drug | combination group |
Primary outcome
reduction of headache frequency
Time frame: 3 months from starting drug
measured by counting
reduction of headache severity
Time frame: 3 months from starting drug
measured by VAS
reduction of headache duration
Time frame: 3 months from starting drug
measured by time in hours
improvement of headache impact
Time frame: 3 months from starting drug
(using HIT-6 scoring)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazi Gias Uddin Ahmed, FCPS, MD study director
Dhaka Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topiramate 25Mg Tab, Amitriptyline 25 Mg Oral Tablet and topiramate 25mg plus amitriptyline 25mg in people with Migraine, run by Dr. Reaz Mahmud at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of headache frequency (time frame: 3 months from starting drug). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.