Phase 2
Completed N=343
Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention
Chronic Migraine or Episodic Migraine
Source: ClinicalTrials.gov NCT03238781 ↗
Enrolled (actual)
343
Serious AEs
1.8%
Results posted
Feb 2020
Primary outcomePrimary: Change From Baseline in Monthly Migraine Days to the Last 4 Weeks of the 12 Week Double-Blind Treatment Period — -2.45; -2.20; -2.19 days — p=0.66
Summary
To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly migraine days in subjects with migraine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Monthly Migraine Days to the Last 4 Weeks of the 12 Week Double-Blind Treatment Period |
-2.45; -2.20; -2.19 | 0.66 |
| SECONDARY Percentage of Participants Who Responded, Defined as At Least a 50% Reduction From the Baseline Period in Monthly Migraine Days in the Last 4 Weeks of the 12-Week Double-Blind Treatment Period |
22.7; 19.4; 18.8 | 0.57 |
| SECONDARY Change From Baseline Period in Monthly Acute Migraine-Specific Medication Days in the Last 4 Weeks of the 12-Week Double-Blind Treatment Period |
-1.25; -1.28; -1.34 | 0.94 |
| SECONDARY Change From Baseline in Mean Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) Over the Last 4 Weeks of the 12-Week Double-Blind Treatment Period |
-2.44; -2.72; -2.13 | 0.81 |
| SECONDARY Change From Baseline in Mean Impact on Everyday Activity Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) Over the Last 4 Weeks of the 12-Week Double-Blind Treatment Period |
-3.42; -4.28; -2.86 | 0.46 |
| SECONDARY Participants With Treatment-Emergent Adverse Events (TEAEs) |
90; 71; 65; 41; 43; 39 | — |
| SECONDARY Percentage of Participants Who Met Hy's Law Criteria at Baseline and On Study |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Aminotransferase Test Abnormalities > 3 Times the Upper Limit of Normal (ULN) at Baseline and On Study |
0; 1.9; 0; 0.7; 1.9; 0 | — |
| SECONDARY Percentage of Participants With Total Bilirubin Test Abnormalities > 2 Times the Upper Limit of Normal (ULN) at Baseline and On Study |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit |
0.9; 0.0; 0.0; 5.5; 7.9; 4.9 | — |
| SECONDARY Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit |
0.0; 0.0; 0.0; 4.5; 6.7; 7.4 | — |
| SECONDARY Percentage of Participants With Pulse Rate in Categories by Visit |
15.5; 13.5; 6.2; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Temperature in Categories by Visit |
5.5; 10.1; 7.4; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Respiratory Rates in Categories by Visit |
4.6; 2.2; 3.8; 0.0; 2.2; 1.3 | — |
Eligibility Criteria
Inclusion Criteria
- Adults ≥ 18 to ≤ 60 years of age at the time of signing the informed consent form.
- History of migraine (with or without aura) for ≥ 12 months before screening according to the International Headache Society (IHS) Classification ICHD-III (Headache Classification Committee of the International Headache Society, 2013)
- Migraine frequency: ≥ 4 migraine days per month on average across the 3 months before screening.
- Failed at least 1 medication for prophylactic treatment of migraine due to tolerability or lack of efficacy
Exclusion Criteria
- Older than 50 years of age at migraine onset.
- History of cluster headache, hemiplegic migraine headache.
- Unable to differentiate migraine from other headaches.
- Migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period.
- History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Data sourced from ClinicalTrials.gov (NCT03238781). 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. Informational only — not medical advice.