MigrainePhase 2NCT06158230
Comparison of Efficacy Between Combination of Amitriptyline-propranolol and Pizotifen for Migraine Prophylaxis.
A Phase 2 study testing Pizotifen and Amitriptyline-propranolol in people with Migraine, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
The goal of this clinical trial is to compare efficacy and observe common adverse effects of a combination of amitriptyline-propranolol and pizotifen as prophylactic treatments for migraine. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Pizotifen and Amitriptyline-propranolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBangladesh
- Study dates
- 19 Mar 2023to 15 Jan 2024
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient of migraine (with typical aura or without aura) according to ICHD-3 (International Classification of Headache Disorder, 3rd edition) criteria.
- Age at entry: 18 to 50 years (to minimize the risks related to adverse effects of study drugs such as drowsiness, weight gain, A-V conduction block, postural hypotension)
- Patients not on any prophylactic medications.
- Patients willing to take part in the study.
- Patients being able to fill a headache diary successfully \& reliably.
Who cannot join
- Age <18 years or >50 years
- Patients having headache other than migraine, complicated migraine, ophthalmoplegic migraine, catamenial migraine, basilar migraine.
- Patients on prophylactic medication.
- Co-morbidities such as heart failure, hepatic or renal impairment, diabetes, bronchial asthma, malignancy, intracranial vascular aneurysm, pregnancy \& breastfeeding etc.
- Patients having known hypersensitivity to amitriptyline, propranolol or pizotifen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficacy Between Combination of Amitriptyline-propranolol and Pizotifen for Migraine Prophylaxis: A Single-blind Randomized Controlled Trial
The goal of this clinical trial is to compare efficacy and observe common adverse effects of a combination of amitriptyline-propranolol and pizotifen as prophylactic treatments for migraine. The main question it aims to answer is:
- Does pizotifen more effective than the combination of amitriptyline-propranolol in migraine prophylaxis?
Participants will be asked to :
- Maintain the provided headache diary accordingly
- Take supplied drugs as described during clinical visits
- Contact principle investigator if there is any issues regarding drug use and/or their adverse effects
- Conditions
- Migraine
- Being tested
- Pizotifen, Amitriptyline-propranolol
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PizotifenDrug
Pizotifen will be given only at night time to avoid daytime somnolence. Starting dose will be 0.5mg then gradually increased to 1.5 mg
Amitriptyline-propranololDrug
Amitriptyline will be given at bedtime only, starting at 10 mg daily and gradually increasing to 25 mg daily.
Propranolol will be started in 40 mg daily in divided doses, which gradually increases to 80 mg daily in divided doses
| Study group | Role | What they receive |
|---|---|---|
| Amitriptyline-Propranolol | Active comparator | Combination of amitriptyline and propranolol.
Initial 2 weeks:
Amitriptyline 10 mg at bedtime Propranolol 20mg twice daily
Next 2 weeks:
Amitriptyline 25 mg at bedtime Propranolol 20mg three times daily
Next 8 weeks:
Amitriptyline 25 mg at bedtime Propranolol 40mg twice daily Receives: Drug: Amitriptyline-propranolol |
| Pizotifen | Experimental | Pizotifen
Initial 2 weeks:
Pizotifen 0.5 mg at bedtime
Next 2 weeks:
Pizotifen 1 mg at bedtime
Next 8 weeks:
Pizotifen 1.5 mg at bedtime Receives: Drug: Pizotifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of headache per month
Comparison of reduction of frequency of headache attack in immediate last month with initial baseline one month without any medication. These values will be compared between two study groups
Measured: 12 weeks
Duration of headache per month
Comparison of reduction of total duration of headache attack in immediate last month with initial baseline one month without any medication. These values will be compared between two study groups
Measured: 12 weeks
Severity of headache
Comparison of reduction of severity of headache attack in immediate last month with initial baseline one month without any medication using visual analogue scale. The visual analogue scale is numbered from 0 to 10. 0 stands for no pain, 1-3 for mild pain, 4-6 for moderate pain and 7-9 for severe pain and 10 for very severe unbearable pain. These values will be compared between two study groups
Measured: 12 weeks
Secondary outcomes (1)
Adverse effects of drugs
Adverse effects (e.g., somnolence, dizziness, dry mouth, weight gain, constipation, bradycardia) of study drugs will be observed
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start19 Mar 2023
- Primary completion25 Nov 2023 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khandakar Rashed Ahmed, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Kanuj Kumar, MD, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158230
- Sponsor's protocol ID
- 4292
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Islam MA, Shaikh AK, AlamSkM, Sultana D, Islam MS, Rashid MM. Safety and Efficacy of Propranolol and amitriptyline combination therapy in migraine prophylaxis: A Randomized Control Trial. J NatlInstNeurosci Bangladesh, 2018;4(1): 3-7
Israil A, Ahmed S, Rahman KM, Uddin MJ, Dey SK, Battacharjee M, Mondal G, Ali MA, Alam MN, Miah AH, Uddin MS. Efficacy of amitriptyline, pizotifen and propranolol in the prevention of migraine. Mymensingh Med J. 2013 Jan;22(1):93-100.
PubMed 23416816Chitsaz, A., Najafi, M.R., Zangeneh, F.A., Norouzi, R. and Salari, M., 2012. Pizotifen in migraine prevention: A comparison with sodium valproate. Neurology Asia, 17(4), pp.319-324.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy Between Combination of Amitriptyline-propranolol and Pizotifen for Migraine Prophylaxis: A Single-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06158230
- Acronym / sponsor ID
- 4292
- Conditions
- Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 19 Mar 2023 (actual)
- Primary completion
- 25 Nov 2023 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 6 Dec 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 efficacy and observe common adverse effects of a combination of amitriptyline-propranolol and pizotifen as prophylactic treatments for migraine. The main question it aims to answer is:
- Does pizotifen more effective than the combination of amitriptyline-propranolol in migraine prophylaxis?
Participants will be asked to :
- Maintain the provided headache diary accordingly
- Take supplied drugs as described during clinical visits
- Contact principle investigator if there is any issues regarding drug use and/or their adverse effects
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amitriptyline-Propranolol | Active comparator | Drug: Amitriptyline-propranololCombination of amitriptyline and propranolol. Initial 2 weeks: Amitriptyline 10 mg at bedtime Propranolol 20mg twice daily Next 2 weeks: Amitriptyline 25 mg at bedtime Propranolol 20mg three times daily Next 8 weeks: Amitriptyline 25 mg at bedtime Propranolol 40mg twice daily |
| Pizotifen | Experimental | Drug: PizotifenPizotifen Initial 2 weeks: Pizotifen 0.5 mg at bedtime Next 2 weeks: Pizotifen 1 mg at bedtime Next 8 weeks: Pizotifen 1.5 mg at bedtime |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient of migraine (with typical aura or without aura) according to ICHD-3 (International Classification of Headache Disorder, 3rd edition) criteria.
- Age at entry: 18 to 50 years (to minimize the risks related to adverse effects of study drugs such as drowsiness, weight gain, A-V conduction block, postural hypotension)
- Patients not on any prophylactic medications.
- Patients willing to take part in the study.
- Patients being able to fill a headache diary successfully \& reliably.
Key exclusion criteria (5 listed)
- Age <18 years or >50 years
- Patients having headache other than migraine, complicated migraine, ophthalmoplegic migraine, catamenial migraine, basilar migraine.
- Patients on prophylactic medication.
- Co-morbidities such as heart failure, hepatic or renal impairment, diabetes, bronchial asthma, malignancy, intracranial vascular aneurysm, pregnancy \& breastfeeding etc.
- Patients having known hypersensitivity to amitriptyline, propranolol or pizotifen
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 |
|---|---|---|
| PizotifenPizotifen will be given only at night time to avoid daytime somnolence. Starting dose will be 0.5mg then gradually increased to 1.5 mg | Drug | Pizotifen |
| Amitriptyline-propranololAmitriptyline will be given at bedtime only, starting at 10 mg daily and gradually increasing to 25 mg daily. Propranolol will be started in 40 mg daily in divided doses, which gradually increases to 80 mg daily in divided doses | Drug | Amitriptyline-Propranolol |
Primary outcome
Frequency of headache per month
Time frame: 12 weeks
Comparison of reduction of frequency of headache attack in immediate last month with initial baseline one month without any medication. These values will be compared between two study groups
Duration of headache per month
Time frame: 12 weeks
Comparison of reduction of total duration of headache attack in immediate last month with initial baseline one month without any medication. These values will be compared between two study groups
Severity of headache
Time frame: 12 weeks
Comparison of reduction of severity of headache attack in immediate last month with initial baseline one month without any medication using visual analogue scale. The visual analogue scale is numbered from 0 to 10. 0 stands for no pain, 1-3 for mild pain, 4-6 for moderate pain and 7-9 for severe pain and 10 for very severe unbearable pain. These values will be compared between two study groups
1 secondary outcome
Adverse effects of drugs
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- BackgroundIslam MA, Shaikh AK, AlamSkM, Sultana D, Islam MS, Rashid MM. Safety and Efficacy of Propranolol and amitriptyline combination therapy in migraine prophylaxis: A Randomized Control Trial. J NatlInstNeurosci Bangladesh, 2018;4(1): 3-7
- Background: PubMed 23416816Israil A, Ahmed S, Rahman KM, Uddin MJ, Dey SK, Battacharjee M, Mondal G, Ali MA, Alam MN, Miah AH, Uddin MS. Efficacy of amitriptyline, pizotifen and propranolol in the prevention of migraine. Mymensingh Med J. 2013 Jan;22(1):93-100.
- BackgroundChitsaz, A., Najafi, M.R., Zangeneh, F.A., Norouzi, R. and Salari, M., 2012. Pizotifen in migraine prevention: A comparison with sodium valproate. Neurology Asia, 17(4), pp.319-324.
- Individual participant dataSharing planned: Yes
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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.
Kanuj Kumar, MD study chair
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pizotifen and Amitriptyline-propranolol in people with Migraine, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh 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 5 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 6 Dec 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Frequency of headache per month (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06158230, which also lists 3 linked publications.
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 6 Dec 2023.