Status:
COMPLETED
Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Episodic Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic migraine
Detailed Description
This study used a single-cohort, 3-treatment arm, randomized, double-blind study design in adult patients with episodic migraine. The subjects were randomized to receive either erenumab or placebo in ...
Eligibility Criteria
Inclusion
- Key inclusion criteria:
- Documented history of migraine in the 12 months prior to screening
- 4-14 days per month of migraine symptoms
- \>=80% diary compliance during the Baseline period
- Key exclusion criteria:
- \>50 years old at migraine onset
- Pregnant or nursing
- History of cluster or hemiplegic headache
- Evidence of seizure or major psychiatric disorder
- Score of 19 or higher on the BDI
- Active chronic pain syndrome
- Cardiac or hepatic disease
Exclusion
Key Trial Info
Start Date :
February 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2020
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT03333109
Start Date
February 8 2018
End Date
January 13 2020
Last Update
October 11 2021
Active Locations (81)
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1
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1056ABJ
2
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1181ACH
3
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1428AQK
4
Novartis Investigative Site
Buenos Aires, Argentina, 1061