EUCTR2018-001228-20-GR
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
- 600
- Status
- Active, not recruiting
- Last Updated
- 5 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
Exclusion Criteria
- •\- Older than 50 years of age at migraine onset.
- •\- Lack of efficacy or poor tolerability with \> 2 treatments from thefollowing 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
Outcomes
Primary Outcomes
Not specified
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