EUCTR2018-001228-20-PT
Active, not recruiting
Phase 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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Migraine prevention
- Sponsor
- ovartis Pharma AG
- Enrollment
- 621
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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