Phase 2
N=609
A Study to Assess the Long-term Safety and Efficacy of Erenumab (AMG 334) in Chronic Migraine Prevention.
Treatment for Prevention of Chronic Migraine
Bottom Line
View on ClinicalTrials.gov: NCT02174861 ↗Enrolled (actual)
609
Serious AEs
3.9%
Results posted
Jun 2018
Primary outcome: Primary: Number of Participants With Adverse Events — 398; 302; 34; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Erenumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
398; 302; 34; 0; 114; 24 | — |
| PRIMARY CHU Substudy: Number of Participants Able to Administer a Full Dose of Erenumab in Home-use |
25; 26; 25; 25 | — |
| SECONDARY Change From Study 20120295 Baseline in Monthly Migraine Days |
18.11; -6.72; -7.38; -7.63; -8.36; -8.72 | — |
| SECONDARY Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Study 20120295 Baseline |
39.2; 45.6; 45.7; 53.6; 55.6; 59.0 | — |
| SECONDARY Change From Study 20120295 Baseline in Monthly Acute Migraine-Specific Medication Treatment Days |
9.53; -3.59; -4.01; -3.96; -4.39; -4.58 | — |
| SECONDARY Change From Study 20120295 Baseline in Cumulative Monthly Headache Hours |
226.84; -79.38; -85.24; -89.30; -100.41; -101.07 | — |
| SECONDARY CHU Substudy: Number of Participants With Adverse Events |
2; 6; 1; 4; 0; 0 | — |
Summary
To assess the long-term safety and efficacy of erenumab.
Eligibility Criteria
Inclusion Criteria
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures
- 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
- 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.
- Systolic blood pressure (BP) 160 mm Hg and/or diastolic BP 100 mm Hg or greater at screening/Day 1.
- Subject who used excluded concomitant medications between week 8 and week 12 of the parent study
Data sourced from ClinicalTrials.gov (NCT02174861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.