Study Complete
Sponsor ID
AMG334A2401

Study of sustained benefit of AMG334 in adult episodic migraine patients

Sponsor ID
AMG334A2401
Clinicaltrials.gov ID
NCT03927144
EUCTIS ID
N/A
EudraCT ID
2018-001228-20

Study Details

The purpose of this study is to compare the sustained long-term benefit between two treatment paradigms of migraine prophylactic agents (erenumab versus a control arm of oral prophylactics) in episodic migraine patients who have previously failed 1 to 2 prophylactic migraine treatments.

Additional Study Details

Phase
Phase 4
Product
AMG 334
Type
Interventional
Masking
None (Open Label)
Enrollment
621
Additional Study Details

Protocol Summary

Primary Outcome Measures

Proportion of subjects who complete initially assigned treatment and achieve at least 50% reduction from baseline in monthly migraine days at Month 12

Timeframe: Month 12

Secondary Outcome Measures

Proportion of subjects completing the treatment period at Month 12 on the initially assigned treatment

Timeframe: Month 12

Cumulative average change from baseline on the monthly migraine days during the treatment period for subjects on the initially assigned treatment (Months 1-12)

Timeframe: Month 12

Proportion of responders (PGI-I score greater than or equal to 5) as measured by PGIC at month 12 for subjects completing the treatment period at Month 12 on initially assigned treatment

Timeframe: Month 12

Locations

Location
Status
Contact Us
Location
Mercy Health Research
St. Louis, MO, United States, 63141
Status
Recruiting
Location
MHNI
Ann Arbor, MI, United States, 48104
Status
Recruiting
Location
Medvadis
Watertown, MA, United States, 02472
Status
Recruiting
Location
Stanford Headache Center
Stanford, CA, United States, 94305
Status
Recruiting
Location
Clinical Research Institute
Minneapolis, MN, United States, 55402
Status
Recruiting
Location
New England Regional Headache Center, Inc
Worcester, MA, United States, 01605
Status
Recruiting
Showing {first} - {last} of {total} Results