Status:
COMPLETED
Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study was to evaluate the efficacy and safety of erenumab in patients with chronic migraine in Asian population.
Detailed Description
This study used a single-cohort, 2-treatment arms, randomized (1:1 (70 mg:placebo)), double-blind study design in adult subjects with chronic migraine. A screening period of 2 weeks was used to assess...
Eligibility Criteria
Inclusion
- key inclusion Criteria:
- History of at least 5 attacks of migraine
- ≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine days during the baseline period
- \>=80% diary compliance during the baseline period
- Key exclusion Criteria:
- Older than 50 years of age at migraine onset
- History of cluster or hemiplegic headache
- Evidence of seizure or major psychiatric disorder
- Cardiac or active hepatic disease
- Pregnant or nursing
Exclusion
Key Trial Info
Start Date :
August 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
557 Patients enrolled
Trial Details
Trial ID
NCT03867201
Start Date
August 26 2019
End Date
April 30 2024
Last Update
October 16 2025
Active Locations (63)
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1
Novartis Investigative Site
Beijing, Beijing Municipality, China, 100000
2
Novartis Investigative Site
Beijing, Beijing Municipality, China, 100039
3
Novartis Investigative Site
Xiamen, Fujian, China, 361001
4
Novartis Investigative Site
Guangzhou, Guangdong, China, 510000