EUCTR2018-001228-20-PTActive, not recruitingPhase 1
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma AG
- Enrollment
- 621
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Adults =18 of age upon entry into screening.
- •- Documented history of migraine (with or without aura) =12 months prior to screening.
- •- =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 nonmigraine)
- •- 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 (see list of prophylactic therapies in Exclusion Criteria 6 and definition for lack of efficacy and 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 months.
- •- 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •- 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
- •after an adequate therapeutic trial. These medication categories are:
- •Category 1: Divalproex sodium, sodium valproate, Category 2:
- •Topiramate, Category 3: Beta blockers, Category 4: Tricyclic
- •antidepressants, Category 5: Serotonin-norepinephrine reuptake
- •inhibitors, Category 6: Flunarizine, verapamil, Category 7: Lisinopril,
- •candesartan
- •Efficacy failure is defined as no meaningful reduction in headache
- •frequency, duration, and/or severity after administration of the
- •medication for at least 6 weeks at the generally accepted therapeutic
- •dose(s) based on the investigator's assessment. Tolerability failure is
- •defined as documented discontinuation due to adverse events of the
- •respective medication during the last 6 months prior to screening.
- •The following scenarios do not constitute lack of therapeutic response:
- •--Lack of sustained response to a medication
- •--Patient decision to halt treatment due to improvement
- •- Used a prohibited medication from the 7 categories of prior
- •prophylactic medications within 3 months prior to start of and during
- •baseline for a non-migraine indication if dose is not stable.
- •- 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
- •- Device, or procedure that potentially may interfere with the intensity or
- •number of migraine days within 2 months prior to the start of or during
- •- Previous exposure to erenumab or exposure to any other prophylactic
- •CGRP-targeted therapy prior to the study.
Investigators
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