Back to Search Results
Study Complete
Sponsor ID
20130255

A Study to Assess the Long-term Safety and Efficacy of Erenumab (AMG 334) in Chronic Migraine Prevention.

Sponsor ID
20130255
Clinicaltrials.gov ID
NCT02174861
EUCTIS ID
N/A
EudraCT ID
2013-005311-27
Contact Us

Study Details

To assess the long-term safety and efficacy of erenumab.

Additional Study Details

Phase
Phase 2
Product
AMG 334
Type
Interventional
Masking
None (Open Label)
Enrollment
609
Additional Study Details

Protocol Summary

Primary Outcome Measures

The safety and tolerability of long-term administration of AMG 334 will be measured by the number of participants with treatment-related AEs reported in the eCRFs.

Timeframe: 13 months –Completion of Open Label treatment

CHU Substudy: Number of participants able to administer a full dose of AMG 334 in home-use, using either two prefilled syringes (PFS) or two prefilled autoinjector/pens (AI/pen) as recorded on the IP Admin page of the eCRFs

Timeframe: 3 months out of the 13 months –Completion of Open Label treatment

Secondary Outcome Measures

Number of participants reporting monthly migraine days from baseline in eDiary

Timeframe: 13 months –Completion of Open Label treatment

Number of participants with at least a 50% reduction from baseline in monthly migraine days as reported in eDiary

Timeframe: 13 months –Completion of Open Label treatment

Number of participants with a change from baseline in monthly acute migraine-specific medication treatment days as reported in eDiary and Con-Med Page of eCRFs

Timeframe: 13 months –Completion of Open Label treatment

Number of participants with a change from baseline in monthly cumulative hours of headache as reported in eDiary and eCRFs

Timeframe: 13 months –Completion of Open Label treatment

CHU Substudy: the safety and tolerability of AMG 334 administered using two 1-mL PFS or two 1-mL AI/pens will be measured by the number of participants with device releated AE/ADEs reported on the eCRFs

Timeframe: 3 months out of the 13 months –Completion of Open Label treatment

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Stockholm, Sweden, 112 45
Status
Recruiting
Location
Research Site
West Palm Beach, FL, United States, 33407
Status
Recruiting
Location
Research Site
Nashville, TN, United States, 37203
Status
Recruiting
Location
Research Site
Stockholm, Sweden, 114 33
Status
Recruiting
Location
Research Site
Ann Arbor, MI, United States, 48104
Status
Recruiting
Location
Research Site
St. Louis, MO, United States, 63141
Status
Recruiting
Showing {first} - {last} of {total} Results
Study Info
Age
18 - 66 Years
Condition
  • Migraine
    • Sex
    All
    Trial Dates
    Jun 2014 - May 2017
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    1. Subject has provided informed consent prior to initiation of any study-specific activities/procedures 2. Completed the 12-week study visit and did not end IP early during the double-blind treatment period of the AMG 334 20120295 (NCT02066415) parent study, and is appropriate for continued treatment.
    Exclusion Criteria:
    1. Development of any unstable or clinically significant medical condition, laboratory or electrocardiogram (ECG) abnormality following randomization into the parent study, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. 2. Systolic blood pressure (BP) 160 mm Hg and/or diastolic BP 100 mm Hg or greater at screening/Day 1. 3. Subject who used excluded concomitant medications between week 8 and week 12 of the parent study