NCT06158230 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
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.

Comparison of Efficacy Between Combination of Amitriptyline-propranolol and Pizotifen for Migraine Prophylaxis: A Single-blind Randomized Controlled Trial

Details for clinical trial NCT06158230

Clinical trial NCT06158230 - References