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 sites30 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•\- 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

•\- 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

Not specified