Phase 1
Completed N=12
To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients
Source: ClinicalTrials.gov NCT02542605 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Number of Participants With a MLA Within 24 Hours of Challenge Agent Infusion — 1; 1; 8; 6 Participants
Summary
Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced Migraine-like Attacks in Migraine Patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a MLA Within 24 Hours of Challenge Agent Infusion |
1; 1; 8; 6 | — |
| SECONDARY Number of Participants With a Headache Within 24 Hours of Challenge Agent Infusion |
3; 3; 6; 4 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
6; 0; 9; 7; 0; 0 | — |
| SECONDARY Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Day 1, Day 8 and EOS |
-0.7; 2.4; 1.2; 0.7; -3.1; -3.7 | — |
| SECONDARY Mean Change From Baseline in Heart Rate at Day 1, Day 8 and EOS |
-5.0; 1.7; 2.6; 8.7; -0.9; 2.4 | — |
| SECONDARY Mean Change From Baseline in Respiratory Rate at Day 1, Day 8 and EOS |
0.8; -1.4; 1.0; -1.0; 1.7; 1.1 | — |
| SECONDARY Mean Change From Baseline in Temperature at Day 1, Day 8 and EOS |
0.18; 0.34; 0.60; 0.63; -0.34; 0.16 | — |
| SECONDARY Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at Day 8, Day 9 and EOS |
-2.0; 0.0; -1.6; -0.3; 1.0; 6.1 | — |
| SECONDARY Mean Change From Baseline in Total Bilirubin at Day 8, Day 9 and EOS |
-0.4211; -1.4849; 3.3229; -2.2980; 0.0804; 1.3191 | — |
| SECONDARY Mean Change From Baseline in Blood Urea at Day 8, Day 9 and EOS |
0.0629; -0.0524; 0.1501; -0.5278; -0.1961; 0.0570 | — |
| SECONDARY Mean Change From Baseline in Creatine Kinase at Day 8, Day 9 and EOS |
5.8; -22.4; -16.8; -59.3; 8.1; -24.9 | — |
| SECONDARY Mean Change From Baseline in Creatinine at Day 8, Day 9 and EOS |
-1.9890; -2.2526; 0.1450; -1.4733; 3.5151; -0.3457 | — |
| SECONDARY Mean Change From Baseline in Direct Bilirubin at Day 8, Day 9 and EOS |
-0.0570; -1.0260; 0.6270; -1.1115; 0.1710; 1.1970 | — |
| SECONDARY Mean Change From Baseline in Eosinophil Count at Day 8, Day 9 and EOS |
-0.013; -0.004; -0.035; -0.002; -0.041; 0.033 | — |
| SECONDARY Mean Change From Baseline in Blood Glucose at Day 8, Day 9 and EOS |
-0.1360; -0.2761; -0.2290; 0.0427; -0.3183; -0.1237 | — |
| SECONDARY Mean Change From Baseline in Hemoglobin A1C (Fraction of 1) at Day 8, Day 9 and EOS |
0.0003; 0.0001; 0.0000; 0.0002; 0.0003; 0.0002 | — |
| SECONDARY Pharmacokinetics (PK): Mean Erenumab Serum Concentration at 1 Hour (C1h) |
51.2 | — |
| SECONDARY PK: Mean Area Under the Concentration-time Curve From Time 0 to 84 Days Post-dose (AUC84d) |
877 | — |
| SECONDARY Number of Participants With Anti-Erenumab Antibodies |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Physical Parameters |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Neurological Assessments |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Adults ≥ 18 to ≤ 45 years of age upon entry into screening
- History of migraine headaches without aura for ≥ 6 months prior to screening according to the International Headache Society (IHS) International Classification of Headache Disorders (ICHD-II) (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report
- Migraine frequency: ≥ 1 and ≤ 5 migraine days per month in each of the 3 months prior to screening
Exclusion Criteria
- History of migraine with aura, cluster headache or hemiplegic migraine headache according to the IHS Classification ICHD-II (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report
- ≥ 6 migraine days per month in the last 3 months prior to study enrollment and during screening period
- Other headache disorders (except for episodic tension-type headache <5 days/month)
Data sourced from ClinicalTrials.gov (NCT02542605). 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.