Comparison of Efficacy Between Combination of Amitriptyline-propranolol and Pizotifen for Migraine Prophylaxis.
NCT ID: NCT06158230
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
140 participants
INTERVENTIONAL
2023-03-19
2024-01-15
Brief Summary
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• 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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Amitriptyline-Propranolol
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
Amitriptyline-propranolol
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
Pizotifen
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
Pizotifen
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
Interventions
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Pizotifen
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-propranolol
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
Eligibility Criteria
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Inclusion Criteria
2. 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)
3. Patients not on any prophylactic medications.
4. Patients willing to take part in the study.
5. Patients being able to fill a headache diary successfully \& reliably.
Exclusion Criteria
2. Patients having headache other than migraine, complicated migraine, ophthalmoplegic migraine, catamenial migraine, basilar migraine.
3. Patients on prophylactic medication.
4. Co-morbidities such as heart failure, hepatic or renal impairment, diabetes, bronchial asthma, malignancy, intracranial vascular aneurysm, pregnancy \& breastfeeding etc.
5. Patients having known hypersensitivity to amitriptyline, propranolol or pizotifen
18 Years
50 Years
ALL
Yes
Sponsors
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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
OTHER
Responsible Party
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Khandakar Rashed Ahmed
Principal Investigator
Principal Investigators
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Kanuj Kumar, MD
Role: STUDY_CHAIR
Professor
Locations
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Bangabandhu Sheikh Mujib Medical University
Dhaka, , Bangladesh
Countries
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References
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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.
Chitsaz, 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.
Other Identifiers
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4292
Identifier Type: -
Identifier Source: org_study_id