Status:
COMPLETED
Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study used a single-cohort, 2-treatment arm, parallel-group randomized, double-blind, double-dummy design in adult patients with episodic migraine and chronic migraine, who had to be either naïve...
Detailed Description
All patients completing the Baseline period and fulfilling baseline eligibility criteria were invited to participate to the Double-blind, double-dummy Treatment Epoch (DBTE, 24 weeks) . Eligible pati...
Eligibility Criteria
Inclusion
- Key
- Documented history of migraine in the 12 months prior to screen
- at least 4 days per month of migraine symptoms
- \>=80% diary compliance during the Baseline period
- Patients must be either naïve or not suitable or have failed previous migraine prophylactic treatments
- Key
Exclusion
- Older than 50 years of age at migraine onset
- Pregnant or nursing
- History of cluster or hemiplegic headache
- History or evidence of major psychiatric disorder
- Score of 19 or higher on Beck Depression Inventory (BDI)
Key Trial Info
Start Date :
February 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2020
Estimated Enrollment :
777 Patients enrolled
Trial Details
Trial ID
NCT03828539
Start Date
February 22 2019
End Date
July 29 2020
Last Update
October 11 2021
Active Locations (79)
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1
Novartis Investigative Site
Stuttgart, Baden-Wurttemberg, Germany, 70178
2
Novartis Investigative Site
Marburg Wehrda, Germany, Germany, 35041
3
Novartis Investigative Site
Hanover, Lower Saxony, Germany, 30159
4
Novartis Investigative Site
Aachen, North Rhine-Westphalia, Germany, 52062