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IRCT20260630070026N1 IRCT 2026-07-07 Faisalabad Medical University Venlafaxine versus amitriptyline for prevention of migraine VAM Trial Comparison of Efficacy of Venlafaxine and Amitriptyline in Migraine Prophylaxis: A Randomized Controlled Trial 2025-08-01 anticipated 126 Complete https://irct.ir/trial/91450 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible participants were randomized in a 1:1 ratio using a computer-generated random number table. Allocation was concealed in sealed opaque envelopes. Participants were assigned to Group A receiving venlafaxine extended-release or Group B receiving amitriptyline, Blinding description: Blinding of participants and treating physicians was not feasible because venlafaxine and amitriptyline have different dosing schedules and adverse-effect profiles. However, outcome assessment was performed by a clinician who was blinded to treatment allocation. 4 Episodic migraine. Intervention 1: Intervention group:. Intervention 2: Intervention group:. No - There is not a plan to make this available Justification or reason for not sharing IPD is Deidentified individual participant data will not be publicly shared because of participant confidentiality and because consent was not specifically obtained for public data sharing. Relevant study documents, including the study protocol and informed consent form, may be made available by the principal investigator on reasonable request and subject to institutional approval.
public Aasim Ali
Chak number 4 JB Reh
Faisalabad Pakistan 38000 +92 345 1129704 dr.aasimali1111@gmail.com Faisalabad Medical University scientific Aasim Ali
Sargodha Road
Faisalabad Pakistan 38000 +92 345 1129704 dr.aasimali1111@gmail.com Faisalabad Medical University Pakistan Adults aged 18 to 70 years; diagnosis of migraine according to International Headache Society criteria for at least 2 years; Episodic migraine with 3 to 10 migraine attacks per month; ability to provide written informed consent. 18 years 70 years Both Secondary headache disorders; major depression or psychiatric illness requiring medication; hypersensitivity to venlafaxine or amitriptyline; hepatic impairment; renal impairment; significant cardiac disease; pregnancy; lactation; concurrent monoamine oxidase inhibitor use; unwillingness to provide informed consent. G43.9 Migraine, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: Efficacy, defined as reduction in migraine severity by at least one grade on a 1 to 3 clinical severity scale compared with baseline. Timepoint: Baseline and 12 weeks after start of treatment. Method of measurement: Clinical migraine severity scale: 1 = mild, able to work; 2 = moderate, unable to work; 3 = severe, bedridden. Frequency of treatment-emergent adverse events. Timepoint: Assessed during follow-up visits at week 4, week 8, and week 12. Method of measurement: Clinical assessment and adverse-event reporting, graded according to CTCAE version 5.0. Faisalabad Medical University Approved 2025-07-28 Faisalabad Medical Univeristy Sargodha Road Faisalabad Punjab Pakistan