Phase 2
N=483
Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT01952574 ↗Enrolled (actual)
483
Serious AEs
6.5%
Results posted
Jul 2018
Primary outcome: Primary: Change From Baseline in Monthly Migraine Days at Week 12 — -2.28; -2.18; -2.39; -3.40 migraine days / month — p=0.021
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Erenumab (Drug); Placebo (Drug); Erenumab PFS (Drug); Erenumab AI/Pen (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Monthly Migraine Days at Week 12 |
-2.28; -2.18; -2.39; -3.40 | 0.021 sig |
| PRIMARY CHU Substudy: Number of Participants Who Self-administered a Full Dose, Partial Dose, or No Dose of Erenumab |
39; 41; 1; 0; 2; 0 | — |
| SECONDARY Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Week 12 |
29.9; 28.8; 34.4; 46.5 | 0.011 sig |
| SECONDARY Change From Baseline in Monthly Migraine Attacks at Week 12 |
-1.44; -1.07; -1.42; -1.84 | 0.13 |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events in the Double-blind Treatment Phase |
81; 57; 55; 57; 1; 1 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events in the Open-label Treatment Phase |
323; 216; 340; 30; 25; 49 | — |
| SECONDARY CHU Substudy: Number of Participants With Treatment-emergent Adverse Events During the CHU Substudy |
13; 17; 7; 10; 1; 2 | — |
| SECONDARY Number of Participants Who Developed Anti-erenumab Antibodies During the Double-blind Treatment Phase |
0; 13; 12; 8; 0; 5 | — |
| SECONDARY Number of Participants Who Developed Anti-erenumab Antibodies During the Open-label Treatment Phase |
12; 8; 6; 5; 1; 0 | — |
Summary
A study to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days in participants with episodic migraine.
Eligibility Criteria
Inclusion Criteria
- History of migraine for more than12 months prior to screening
- Migraine frequency: ≥ 4 and ≤ 14 migraine days per month in each of the 3 months prior to screening and during baseline phase
- Headache frequency: 50% of the headache days being migraine days) in each of the 3 months prior to screening and during baseline phase
- Demonstrated at least 80% compliance with the eDiary during baseline phase
Exclusion Criteria
- Older than 50 years of age at migraine onset
- History of cluster headache or basilar or hemiplegic migraine headache
- Unable to differentiate migraine from other headaches
- No therapeutic response with > 2 of the following eight medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. Medication categories are:
- Category 1: Divalproex sodium, sodium valproate
- Category 2: Topiramate
- Category 3: Beta blockers (for example: atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, propranolol, timolol)
- Category 4: Tricyclic antidepressants (for example: amitriptyline, nortriptyline, protriptyline)
- Category 5: Venlafaxine, desvenlafaxine, duloxetine, milnacipran
- Category 6: Flunarizine, verapamil
- Category 7: Lisinopril, candesartan
- Category 8: Butterbur, feverfew, magnesium (≥ 600 mg/day), riboflavin (≥ 100 mg/day)
- Overuse of acute migraine medications in any month during the 3 months prior to screening or during screening
Data sourced from ClinicalTrials.gov (NCT01952574). 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.