A Phase 1 interventional study of Erenumab and Placebo in Migraine, sponsored by Amgen. Completed at 3 sites in 3 countries. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-06-03.
Sponsored by Amgen · Phase 1, Interventional, and Prevention
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 35 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
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Exclusion Criteria:
In Part A, 4 cohorts of 2 to 5 participants sequentially received an intravenous infusion of 10 picomol/kilogram/minute (pmol/kg/minute) PACAP-38 for 2.5, 5, 7.5 and 10 minutes each in order to determine the dose for Part B.
Drug: PACAP-38 Challenge Agent
Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1. On day 8 participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.
Drug: Placebo · Drug: PACAP-38 Challenge Agent
Participants were randomized to receive 140 milligrams (mg) erenumab by intravenous administration over 30 minutes on day 1 in Part B. On day 8 participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.
Drug: Erenumab · Drug: PACAP-38 Challenge Agent
Administered once on day 1 of Part B of the study by intravenous infusion.
Also known as: AMG 334, Aimovig™
Administered once on day 1 of Part B of the study by intravenous infusion.
Administered by intravenous infusion during Part A of the study for dose selection for Part B. Administered by intravenous infusion on day 8 in Part B as a challenge agent to induce a migraine-like attack.
Also known as: Pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38)
Number of Participants With a MLA Within 24 Hours of Challenge Agent Infusion
On day 1 of the double-blind randomization phase participants received 140 mg intravenous erenumab over 30 minutes or matching placebo. On day 8, participants received 10 mol/kg/minute PACAP-38 over 10 minutes and were observed for 24 hours after PACAP-38 infusion. A MLA was defined as fulfilling 1 of the 2 criteria: 1. Headache with at least 2 of the following characteristics: unilateral location, pulsating quality, moderate or severe pain intensity, aggravated by/causing avoidance of routine physical activity. Additionally, during the headache at least 1 of the following: nausea and/or vomiting, photophobia or phonophobia. 2. Headache described as mimicking usual migraine attack treated with triptan.
Time frame: Part B randomization phase day 8 plus 24 hours.
Number of Participants With a Headache Within 24 Hours of Challenge Agent Infusion
On day 1 of the double-blind randomization phase participants received 140 mg intravenous erenumab over 30 minutes or matching placebo. On day 8, participants received 10 mol/kg/minute PACAP-38 over 10 minutes and were observed for 24 hours after PACAP-38 infusion.
Time frame: Part B randomization phase day 8 plus 24 hours.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs were summarised for days 1 to 7 after the participants received placebo or erenumab infusion on day 1 of the Part B randomization phase. TEAEs were also summarized from day 8 to end of study (EOS) after participants had received both investigational product (placebo or erenumab) and the second dose of PACAP-38 on day 8.
Time frame: Part B randomization phase day 1 until EOS (up to 12 weeks).
Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Day 1, Day 8 and EOS
Systolic and diastolic BP was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.
Time frame: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).
Mean Change From Baseline in Heart Rate at Day 1, Day 8 and EOS
Heart rate was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.
Time frame: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).
Mean Change From Baseline in Respiratory Rate at Day 1, Day 8 and EOS
Respiratory rate was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.
Time frame: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).
Mean Change From Baseline in Temperature at Day 1, Day 8 and EOS
Temperature was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.
Time frame: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at Day 8, Day 9 and EOS
ALP, ALT and AST were assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
Time frame: Part B randomization phase baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Total Bilirubin at Day 8, Day 9 and EOS
Total bilirubin was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
Time frame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Blood Urea at Day 8, Day 9 and EOS
Blood urea was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
Time frame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Creatine Kinase at Day 8, Day 9 and EOS
Creatine Kinase was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
Time frame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Creatinine at Day 8, Day 9 and EOS
Creatinine was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
Time frame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Direct Bilirubin at Day 8, Day 9 and EOS
Direct bilirubin was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
Time frame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Eosinophil Count at Day 8, Day 9 and EOS
Eosinophil count was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
Time frame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Blood Glucose at Day 8, Day 9 and EOS
Blood glucose was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
Time frame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Hemoglobin A1C (Fraction of 1) at Day 8, Day 9 and EOS
Hemoglobin A1C was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
Time frame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Pharmacokinetics (PK): Mean Erenumab Serum Concentration at 1 Hour (C1h)
The mean serum erenumab concentration at 1 hour post-dose on day 1 of Part B randomization phase is presented.
Time frame: Part B randomization phase 1 hour post-dose day 1.
PK: Mean Area Under the Concentration-time Curve From Time 0 to 84 Days Post-dose (AUC84d)
The mean AUC84d for erenumab for the Part B randomization phase is presented.
Time frame: Part B randomization phase baseline and 84 days post-dose.
Number of Participants With Anti-Erenumab Antibodies
Participants were tested for binding antibodies and neutralizing antibodies at baseline and following treatment with erenumab.
Time frame: Part B randomization phase baseline and EOS.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
At baseline, 12-lead ECGs were performed in a standardized method, in triplicate, and approximately 30 seconds apart, prior to blood draws or other invasive procedures. Single ECGs were performed from Day 1 to EOS. ECG results were reviewed by the investigator and classified as: normal, abnormal not clinically significant or abnormal, clinically significant. The number of participants with abnormal, clinically significant changes in ECG results at EOS are presented.
Time frame: Part B randomization phase baseline and EOS.
Number of Participants With Clinically Significant Changes in Physical Parameters
Physical examinations were performed by an investigator and any abnormal findings, judged to be clinically significant were recorded as an AE. The number of participants with clinically significant changes in physical parameters at EOS are presented.
Time frame: Part B randomization phase baseline and EOS.
Number of Participants With Clinically Significant Changes in Neurological Assessments
Neurological examinations including assessment of cranial nerves, motor system, sensory system (including testing for pain sensation \[pin prick\], light touch sensation \[brush\], von Frey, and vibratory sense), reflexes, and cerebellar function were performed by the investigator and classified as normal or abnormal. Any abnormal findings, judged by the investigator to be clinically significant, were recorded as an AE. The number of participants with clinically significant changes in neurological assessments at EOS are presented.
Time frame: Part B randomization phase baseline and EOS.
Participants were enrolled in 2 centers in Belgium and the Netherlands from November 2015 until November 2017 when the study was terminated early due to slow recruitment rate. Additionally, 2 participants were enrolled at a center in the United States for Part A prior to this study site being closed.
| Milestone | PACAP-38 Challenge Agent | Placebo | Erenumab |
|---|---|---|---|
| Started | 12 | 0 | 0 |
| Received pacap-38 | 12 | 0 | 0 |
| Proceeded to part b randomization phase | 2 | 0 | 0 |
| Completed | 12 | 0 | 0 |
| Not completed | 0 | 0 | 0 |
| Milestone | PACAP-38 Challenge Agent | Placebo | Erenumab |
|---|---|---|---|
| Started | 23 | 0 | 0 |
| Received pacap-38 | 23 | 0 | 0 |
| Proceeded to randomization phase | 15 | 0 | 0 |
| Completed | 22 | 0 | 0 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Sponsor decision | 1 | 0 | 0 |
| Milestone | PACAP-38 Challenge Agent | Placebo | Erenumab |
|---|---|---|---|
| Started | 0 | 9 | 8 |
| Not pacap-38 naïve participants | 0 | 2 | 0 |
| Pacap-38 naïve participants | 0 | 7 | 8 |
| Received placebo/erenumab | 0 | 9 | 7 |
| Completed | 0 | 9 | 7 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
On day 1 of the double-blind randomization phase participants received 140 mg intravenous erenumab over 30 minutes or matching placebo. On day 8, participants received 10 mol/kg/minute PACAP-38 over 10 minutes and were observed for 24 hours after PACAP-38 infusion. A MLA was defined as fulfilling 1 of the 2 criteria: 1. Headache with at least 2 of the following characteristics: unilateral location, pulsating quality, moderate or severe pain intensity, aggravated by/causing avoidance of routine physical activity. Additionally, during the headache at least 1 of the following: nausea and/or vomiting, photophobia or phonophobia. 2. Headache described as mimicking usual migraine attack treated with triptan.
| Participants | Placebo | Erenumab |
|---|---|---|
| Participants with MLA | 1 | 1 |
| Participants without MLA | 8 | 6 |
On day 1 of the double-blind randomization phase participants received 140 mg intravenous erenumab over 30 minutes or matching placebo. On day 8, participants received 10 mol/kg/minute PACAP-38 over 10 minutes and were observed for 24 hours after PACAP-38 infusion.
| Participants | Placebo | Erenumab |
|---|---|---|
| Participants with headaches | 3 | 3 |
| Participants without headaches | 6 | 4 |
TEAEs were summarised for days 1 to 7 after the participants received placebo or erenumab infusion on day 1 of the Part B randomization phase. TEAEs were also summarized from day 8 to end of study (EOS) after participants had received both investigational product (placebo or erenumab) and the second dose of PACAP-38 on day 8.
| Participants | Placebo | Erenumab |
|---|---|---|
| Participants with TEAEs from day 1 to 7 | 6 | 0 |
| Participants with TEAEs from day 8 to EOS | 9 | 7 |
| Serious AEs | 0 | 0 |
| AEs with fatal outcome | 0 | 0 |
Systolic and diastolic BP was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.
| millimeters of mercury | Placebo | Erenumab |
|---|---|---|
| 1 hour post-dose day 1: systolic BP | -0.7 ± 7.9 | 2.4 ± 5.2 |
| 1 hour post-dose day 1: diastolic BP | 1.2 ± 5.7 | 0.7 ± 6.4 |
| 8 hours post-dose day 8: systolic BP | -3.1 ± 5.7 | -3.7 ± 6.2 |
| 8 hours post-dose day 8: diastolic BP | -3.6 ± 2.9 | -9.6 ± 6.8 |
| EOS: systolic BP | -2.6 ± 9.2 | 2.6 ± 3.8 |
| EOS: diastolic BP | -0.1 ± 6.4 | 1.7 ± 5.9 |
Heart rate was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.
| beats/minute | Placebo | Erenumab |
|---|---|---|
| 1 hour post-dose day 1 | -5.0 ± 8.2 | 1.7 ± 5.7 |
| 8 hours post-dose day 8 | 2.6 ± 11.5 | 8.7 ± 4.6 |
| EOS | -0.9 ± 8.6 | 2.4 ± 5.5 |
Respiratory rate was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.
| breaths/minute | Placebo | Erenumab |
|---|---|---|
| 1 hour post-dose day 1 | 0.8 ± 2.2 | -1.4 ± 2.6 |
| 8 hours post-dose day 8 | 1.0 ± 2.1 | -1.0 ± 3.5 |
| EOS | 1.7 ± 4.0 | 1.1 ± 3.7 |
Temperature was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.
| degrees Celsius | Placebo | Erenumab |
|---|---|---|
| 1 hour post-dose day 1 | 0.18 ± 0.39 | 0.34 ± 0.36 |
| 8 hours post-dose day 8 | 0.60 ± 0.48 | 0.63 ± 0.56 |
| EOS | -0.34 ± 0.47 | 0.16 ± 0.41 |
ALP, ALT and AST were assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
| Units/Liter | Placebo | Erenumab |
|---|---|---|
| Day 8 (Pre-PACAP-38 dose): ALP | -2.0 ± 5.6 | 0.0 ± 4.8 |
| Day 9 (Post-PACAP-38 dose): ALP | -1.6 ± 4.1 | -0.3 ± 2.3 |
| EOS: ALP | 1.0 ± 12.3 | 6.1 ± 9.6 |
| Day 8 (Pre-PACAP-38 dose): ALT | -1.4 ± 3.5 | -3.0 ± 4.2 |
| Day 9 (Post-PACAP-38 dose): ALT | -2.1 ± 3.5 | -4.5 ± 4.2 |
| EOS: ALT | -2.0 ± 4.7 | 3.1 ± 9.4 |
| Day 8 (Pre-PACAP-38 dose): AST | 0.3 ± 3.0 | 2.4 ± 4.0 |
| Day 9 (Post-PACAP-38 dose): AST | -0.8 ± 2.7 | -4.2 ± 2.3 |
| EOS: AST | 0.3 ± 5.1 | -0.4 ± 3.6 |
Total bilirubin was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
| micromol/L | Placebo | Erenumab |
|---|---|---|
| Day 8 (Pre-PACAP-38 dose) | -0.4211 ± 3.6356 | -1.4849 ± 0.8532 |
| Day 9 (Post-PACAP-38 dose) | 3.3229 ± 1.3971 | -2.2980 ± 1.0300 |
| EOS | 0.0804 ± 3.0270 | 1.3191 ± 3.5099 |
Blood urea was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
| millimol/L (mmol/L) | Placebo | Erenumab |
|---|---|---|
| Day 8 (Pre-PACAP-38 dose) | 0.0629 ± 0.9274 | -0.0524 ± 0.5270 |
| Day 9 (Post-PACAP-38 dose) | 0.1501 ± 0.7552 | -0.5278 ± 1.2592 |
| EOS | -0.1961 ± 0.7673 | 0.0570 ± 1.1286 |
Creatine Kinase was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
| U/L | Placebo | Erenumab |
|---|---|---|
| Day 8 (Pre-PACAP-38 dose) | 5.8 ± 21.0 | -22.4 ± 51.5 |
| Day 9 (Post-PACAP-38 dose) | -16.8 ± 9.1 | -59.3 ± 65.7 |
| EOS | 8.1 ± 25.3 | -24.9 ± 79.9 |
Creatinine was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
| micromol/L | Placebo | Erenumab |
|---|---|---|
| Day 8 (Pre-PACAP-38 dose) | -1.9890 ± 6.0835 | -2.2526 ± 3.1121 |
| Day 9 (Post-PACAP-38 dose) | 0.1450 ± 7.3859 | -1.4733 ± 3.4367 |
| EOS | 3.5151 ± 7.8109 | -0.3457 ± 2.6598 |
Direct bilirubin was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
| micromol/L | Placebo | Erenumab |
|---|---|---|
| Day 8 (Pre-PACAP-38 dose) | -0.0570 ± 1.2948 | -1.0260 ± NA |
| Day 9 (Post-PACAP-38 dose) | 0.6270 ± 0.5497 | -1.1115 ± 0.1209 |
| EOS | 0.1710 ± 0.1710 | 1.1970 ± 0.0000 |
Eosinophil count was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
| 10^9/L | Placebo | Erenumab |
|---|---|---|
| Day 8 (Pre-PACAP-38 dose) | -0.013 ± 0.067 | -0.004 ± 0.046 |
| Day 9 (Post-PACAP-38 dose) | -0.035 ± 0.076 | -0.002 ± 0.066 |
| EOS | -0.041 ± 0.060 | 0.033 ± 0.061 |
Blood glucose was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
| mmol/L | Placebo | Erenumab |
|---|---|---|
| Day 8 (Pre-PACAP-38 dose) | -0.1360 ± 0.3103 | -0.2761 ± 0.5961 |
| Day 9 (Post-PACAP-38 dose) | -0.2290 ± 0.2350 | 0.0427 ± 0.2432 |
| EOS | -0.3183 ± 0.3395 | -0.1237 ± 0.3645 |
Hemoglobin A1C was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
| fraction of 1 | Placebo | Erenumab |
|---|---|---|
| Day 8 (Pre-PACAP-38 dose) | 0.0003 ± 0.0007 | 0.0001 ± 0.0007 |
| Day 9 (Post-PACAP-38 dose) | 0.0000 ± 0.0005 | 0.0002 ± 0.0010 |
| EOS | 0.0003 ± 0.0012 | 0.0002 ± 0.0012 |
The mean serum erenumab concentration at 1 hour post-dose on day 1 of Part B randomization phase is presented.
| micrograms per milliliter (mcg/mL) | Erenumab |
|---|---|
| Pharmacokinetics (PK): Mean Erenumab Serum Concentration at 1 Hour (C1h) | 51.2 ± 9.72 |
The mean AUC84d for erenumab for the Part B randomization phase is presented.
| day*mcg/mL | Erenumab |
|---|---|
| PK: Mean Area Under the Concentration-time Curve From Time 0 to 84 Days Post-dose (AUC84d) | 877 ± 131 |
Participants were tested for binding antibodies and neutralizing antibodies at baseline and following treatment with erenumab.
| Participants | Erenumab |
|---|---|
| Binding antibody positive at/before baseline | 0 |
| Neutralizing antibody positive at/before baseline | 0 |
| Binding antibody positive post-baseline | 0 |
| Neutralizing antibody positive post-baseline | 0 |
At baseline, 12-lead ECGs were performed in a standardized method, in triplicate, and approximately 30 seconds apart, prior to blood draws or other invasive procedures. Single ECGs were performed from Day 1 to EOS. ECG results were reviewed by the investigator and classified as: normal, abnormal not clinically significant or abnormal, clinically significant. The number of participants with abnormal, clinically significant changes in ECG results at EOS are presented.
| Participants | Placebo | Erenumab |
|---|---|---|
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | 0 | 0 |
Physical examinations were performed by an investigator and any abnormal findings, judged to be clinically significant were recorded as an AE. The number of participants with clinically significant changes in physical parameters at EOS are presented.
| Participants | Placebo | Erenumab |
|---|---|---|
| Number of Participants With Clinically Significant Changes in Physical Parameters | 0 | 0 |
Neurological examinations including assessment of cranial nerves, motor system, sensory system (including testing for pain sensation \[pin prick\], light touch sensation \[brush\], von Frey, and vibratory sense), reflexes, and cerebellar function were performed by the investigator and classified as normal or abnormal. Any abnormal findings, judged by the investigator to be clinically significant, were recorded as an AE. The number of participants with clinically significant changes in neurological assessments at EOS are presented.
| Participants | Placebo | Erenumab |
|---|---|---|
| Number of Participants With Clinically Significant Changes in Neurological Assessments | 0 | 0 |
Collected over From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Day 1-7 | 0/9 (0%) | 0/9 (0%) | 6/9 (66.7%) |
| Erenumab Day 1-7 | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Placebo Day 8-EOS | 0/9 (0%) | 0/9 (0%) | 9/9 (100%) |
| Erenumab Day 8-EOS | 0/7 (0%) | 0/7 (0%) | 7/7 (100%) |
| Event | Placebo Day 1-7 | Erenumab Day 1-7 | Placebo Day 8-EOS | Erenumab Day 8-EOS |
|---|---|---|---|---|
| MigraineNervous system disorders | 3/9 | 0/7 | 6/9 | 7/7 |
| FlushingVascular disorders | 0/9 | 0/7 | 7/9 | 6/7 |
| PalpitationsCardiac disorders | 0/9 | 0/7 | 5/9 | 5/7 |
| FatigueGeneral disorders | 1/9 | 0/7 | 4/9 | 5/7 |
| HeadacheNervous system disorders | 0/9 | 0/7 | 6/9 | 3/7 |
| Head discomfortNervous system disorders | 0/9 | 0/7 | 4/9 | 1/7 |
| Feeling hotGeneral disorders | 0/9 | 0/7 | 3/9 | 2/7 |
| Lacrimation increasedEye disorders | 0/9 | 0/7 | 1/9 | 2/7 |
| Feeling coldGeneral disorders | 0/9 | 0/7 | 0/9 | 2/7 |
| Abdominal pain upperGastrointestinal disorders | 0/9 | 0/7 | 2/9 | 0/7 |
The overall baseline population consists of all participants who received at least 1 dose of PACAP-38 in either Part A or Part B of the study.
| Age, Continuous(Years) | PACAP-38 Challenge Agent |
|---|---|
| Mean | 27.5 ± 6.2 |
| Age, Customized(Participants) | PACAP-38 Challenge Agent |
|---|---|
| 18 - 64 years | 35 |
| Sex: Female, Male(Participants) | PACAP-38 Challenge Agent |
|---|---|
| Female | 30 |
| Male | 5 |
| Race/Ethnicity, Customized(Participants) | PACAP-38 Challenge Agent |
|---|---|
| Asian | 3 |
| Black (or African American) | 2 |
| Multiple (Asian-White) | 1 |
| White | 28 |
| Other | 1 |
| Race/Ethnicity, Customized(Participants) | PACAP-38 Challenge Agent |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 34 |
| Height(centimeters) | PACAP-38 Challenge Agent |
|---|---|
| Mean | 168.13 ± 7.72 |
| Weight(kg) | PACAP-38 Challenge Agent |
|---|---|
| Mean | 69.433 ± 14.656 |
| Body Mass Index(kg/m^2) | PACAP-38 Challenge Agent |
|---|---|
| Mean | 24.4738 ± 4.2926 |
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