A 12-month prospective, randomized, interventional, global, multi-center, active-controlled study comparing sustained benefit of two treatment paradigms (erenumab qm vs. oral prophylactics) in adult episodic migraine patients - CAMG334A2401 (APPRAISE)

ovartis0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•- Adults *18 of age upon entry into screening.
•- Documented history of migraine (with or without aura) *12 months prior to
•- *4 and <15 days per month of migraine symptoms (based on ICHD-3 criteria)
•on average across 3 months prior to screening based on retrospective reporting.
•- < 15 days per month of headache symptoms (i.e., migraine and non-migraine)
•- Subjects in need for switching by documented failure of 1 or 2 prophylactic
•therapies in the last 6 months due to either lack of efficacy or poor
•tolerability. For subjects with 1 prior treatment failure, the failure should
•have occurred in the last 6 months. For subjects with 2 prior treatment
•failures, the second treatment failure should have occurred in the last 6
•- During baseline period, confirmed migraine frequency of 4 to 14 migraine days
•and < 15 days of headache symptoms.
•- During baseline period, *80% compliance with the headache diary.

•- Older than 50 years of age at migraine onset.
•- Lack of efficacy or poor tolerability with > 2 treatments from the following
•7 medication categories for prophylactic treatment of migraine: 1: Divalproex
•sodium, sodium valproate, 2: Topiramate, 3: Beta blocker , 4: Tricyclic
•antidepressants, 5: Serotonin-norepinephrine reuptake inhibitors, 6:
•Flunarizine, verapamil, 7: Lisinopril, candesartan
•- Used a prohibited medication, device, or procedure within 2 months prior to
•the start of or during baseline or during the treatment period.
•- Exposure to botulinum toxin in the head and/or neck region within 4 months
•prior to the start of the baseline period, during the baseline period, or
•treatment period.
•- Taken the following for any indication in any month during the 2 months prior
•to the start of the baseline period:
•- Ergotamines or triptans on * 10 days per month, or
•- Simple analgesics (non-steroidal anti-inflammatory drugs [NSAIDs],
•acetaminophen) on * 15 days per month, or
•- Opioid- or butalbital-containing analgesics on *4 days per month, or
•- Device, or procedure that potientially may interfere with the intensity or
•number of migraine days
•- Previous exposure to erenumab or exposure to any other prophylactic
•CGRP-targeted therapy (prior to and during the study).

发起方