drugset / Trial / NCT06158230
Comparison of Efficacy Between Combination of Amitriptyline-propranolol and Pizotifen for Migraine Prophylaxis.
RandomizedParallel-groupTriple-blindPrevention
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. 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
Timeline
- Start
- 2023-03-19
- Primary completion
- 2023-11-25
- Completion
- 2024-01-15
Publications
- Background 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
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amitriptyline | Small molecule | 25 mg | — |
| Subject | Pizotifen | Small molecule | 1.5 mg | — |
| Comparator | Propranolol | Small molecule | 40 mg | — |