Trial Outcomes & Findings for To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients (NCT NCT02542605)

NCT ID: NCT02542605

Last Updated: 2019-06-03

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 35 participants
• Primary outcome timeframe: Part B randomization phase day 8 plus 24 hours.
• Results posted on: 2019-06-03

Participant Flow

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.

12 participants received treatment in Part A to determine the lowest pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38) dose that triggered a migraine-like attack (MLA). PACAP-38 responders from Part A and PACAP-38 naïve participants were randomized in Part B (17 in total). 35 participants were enrolled in the study (Parts A and B).

Participant milestones

Measure	PACAP-38 Challenge Agent In Part A, cohorts 1 to 4 (of 2 to 5 participants each) sequentially received an intravenous infusion of 10 picomol/kilogram/minute (pmol/kg/minute) PACAP-38 over 2.5, 5, 7.5 and 10 minutes, respectively. Dose selection in Part A enabled the dose for Part B to be determined. PACAP-38 naïve participants entered the study at Part B. On day 1 of the Part B challenge phase participants received the dose of PACAP-38 determined from Part A of the study: 100 pmol/kg (administered as 10 pmol/kg/minute PACAP-38 over 10 minutes). Responders who experienced a MLA within 24 hours were screened for the randomization phase.	Placebo Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab Participants were randomized to receive 140 milligrams (mg) erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Part A: PACAP-38 Dose Selection Phase STARTED	12	0	0
Part A: PACAP-38 Dose Selection Phase Received PACAP-38	12	0	0
Part A: PACAP-38 Dose Selection Phase Proceeded to Part B Randomization Phase	2	0	0
Part A: PACAP-38 Dose Selection Phase COMPLETED	12	0	0
Part A: PACAP-38 Dose Selection Phase NOT COMPLETED	0	0	0
Part B: Challenge Phase STARTED	23	0	0
Part B: Challenge Phase Received PACAP-38	23	0	0
Part B: Challenge Phase Proceeded to Randomization Phase	15	0	0
Part B: Challenge Phase COMPLETED	22	0	0
Part B: Challenge Phase NOT COMPLETED	1	0	0
Part B: Randomization Phase STARTED	0	9	8
Part B: Randomization Phase Not PACAP-38 naïve Participants	0	2	0
Part B: Randomization Phase PACAP-38 naïve Participants	0	7	8
Part B: Randomization Phase Received Placebo/Erenumab	0	9	7
Part B: Randomization Phase COMPLETED	0	9	7
Part B: Randomization Phase NOT COMPLETED	0	0	1

Reasons for withdrawal

Measure	PACAP-38 Challenge Agent In Part A, cohorts 1 to 4 (of 2 to 5 participants each) sequentially received an intravenous infusion of 10 picomol/kilogram/minute (pmol/kg/minute) PACAP-38 over 2.5, 5, 7.5 and 10 minutes, respectively. Dose selection in Part A enabled the dose for Part B to be determined. PACAP-38 naïve participants entered the study at Part B. On day 1 of the Part B challenge phase participants received the dose of PACAP-38 determined from Part A of the study: 100 pmol/kg (administered as 10 pmol/kg/minute PACAP-38 over 10 minutes). Responders who experienced a MLA within 24 hours were screened for the randomization phase.	Placebo Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab Participants were randomized to receive 140 milligrams (mg) erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Part B: Challenge Phase Sponsor decision	1	0	0
Part B: Randomization Phase Withdrawal by Subject	0	0	1

Baseline Characteristics

To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients

Baseline characteristics by cohort

Measure	PACAP-38 Challenge Agent n=35 Participants In Part A, cohorts 1 to 4 (of 2 to 5 participants each) sequentially received an intravenous infusion of 10 pmol/kg/minute PACAP-38 over 2.5, 5, 7.5 and 10 minutes, respectively. Dose selection in Part A enabled the dose for Part B to be determined. PACAP-38 naïve participants entered the study at Part B. On day 1 of the Part B challenge phase participants received the dose of PACAP-38 determined from Part A of the study: 100 pmol/kg (administered as 10 pmol/kg/minute PACAP-38 over 10 minutes). Responders who experienced a MLA within 24 hours were screened for the randomization phase.
Age, Continuous	27.5 Years STANDARD_DEVIATION 6.2 • n=5 Participants
Age, Customized 18 - 64 years	35 Participants n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Black (or African American)	2 Participants n=5 Participants
Race/Ethnicity, Customized Multiple (Asian-White)	1 Participants n=5 Participants
Race/Ethnicity, Customized White	28 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	34 Participants n=5 Participants
Height	168.13 centimeters STANDARD_DEVIATION 7.72 • n=5 Participants
Weight	69.433 kg STANDARD_DEVIATION 14.656 • n=5 Participants
Body Mass Index	24.4738 kg/m^2 STANDARD_DEVIATION 4.2926 • n=5 Participants

PRIMARY outcome

Timeframe: Part B randomization phase day 8 plus 24 hours.

Population: The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab n=7 Participants Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Number of Participants With a MLA Within 24 Hours of Challenge Agent Infusion Participants with MLA	1 Participants	1 Participants
Number of Participants With a MLA Within 24 Hours of Challenge Agent Infusion Participants without MLA	8 Participants	6 Participants

SECONDARY outcome

Timeframe: Part B randomization phase day 8 plus 24 hours.

Population: The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab n=7 Participants Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Number of Participants With a Headache Within 24 Hours of Challenge Agent Infusion Participants with headaches	3 Participants	3 Participants
Number of Participants With a Headache Within 24 Hours of Challenge Agent Infusion Participants without headaches	6 Participants	4 Participants

SECONDARY outcome

Timeframe: Part B randomization phase day 1 until EOS (up to 12 weeks).

Population: The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab n=7 Participants Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Participants with TEAEs from day 1 to 7	6 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Participants with TEAEs from day 8 to EOS	9 Participants	7 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Serious AEs	0 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) AEs with fatal outcome	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).

Population: The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab n=7 Participants Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Day 1, Day 8 and EOS 1 hour post-dose day 1: systolic BP	-0.7 millimeters of mercury Standard Deviation 7.9	2.4 millimeters of mercury Standard Deviation 5.2
Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Day 1, Day 8 and EOS 1 hour post-dose day 1: diastolic BP	1.2 millimeters of mercury Standard Deviation 5.7	0.7 millimeters of mercury Standard Deviation 6.4
Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Day 1, Day 8 and EOS 8 hours post-dose day 8: systolic BP	-3.1 millimeters of mercury Standard Deviation 5.7	-3.7 millimeters of mercury Standard Deviation 6.2
Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Day 1, Day 8 and EOS 8 hours post-dose day 8: diastolic BP	-3.6 millimeters of mercury Standard Deviation 2.9	-9.6 millimeters of mercury Standard Deviation 6.8
Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Day 1, Day 8 and EOS EOS: systolic BP	-2.6 millimeters of mercury Standard Deviation 9.2	2.6 millimeters of mercury Standard Deviation 3.8
Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Day 1, Day 8 and EOS EOS: diastolic BP	-0.1 millimeters of mercury Standard Deviation 6.4	1.7 millimeters of mercury Standard Deviation 5.9

SECONDARY outcome

Timeframe: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).

Population: The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab n=7 Participants Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Mean Change From Baseline in Heart Rate at Day 1, Day 8 and EOS 1 hour post-dose day 1	-5.0 beats/minute Standard Deviation 8.2	1.7 beats/minute Standard Deviation 5.7
Mean Change From Baseline in Heart Rate at Day 1, Day 8 and EOS 8 hours post-dose day 8	2.6 beats/minute Standard Deviation 11.5	8.7 beats/minute Standard Deviation 4.6
Mean Change From Baseline in Heart Rate at Day 1, Day 8 and EOS EOS	-0.9 beats/minute Standard Deviation 8.6	2.4 beats/minute Standard Deviation 5.5

SECONDARY outcome

Timeframe: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).

Population: The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab n=7 Participants Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Mean Change From Baseline in Respiratory Rate at Day 1, Day 8 and EOS 1 hour post-dose day 1	0.8 breaths/minute Standard Deviation 2.2	-1.4 breaths/minute Standard Deviation 2.6
Mean Change From Baseline in Respiratory Rate at Day 1, Day 8 and EOS 8 hours post-dose day 8	1.0 breaths/minute Standard Deviation 2.1	-1.0 breaths/minute Standard Deviation 3.5
Mean Change From Baseline in Respiratory Rate at Day 1, Day 8 and EOS EOS	1.7 breaths/minute Standard Deviation 4.0	1.1 breaths/minute Standard Deviation 3.7

SECONDARY outcome

Timeframe: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).

Population: The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab n=7 Participants Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Mean Change From Baseline in Temperature at Day 1, Day 8 and EOS 1 hour post-dose day 1	0.18 degrees Celsius Standard Deviation 0.39	0.34 degrees Celsius Standard Deviation 0.36
Mean Change From Baseline in Temperature at Day 1, Day 8 and EOS 8 hours post-dose day 8	0.60 degrees Celsius Standard Deviation 0.48	0.63 degrees Celsius Standard Deviation 0.56
Mean Change From Baseline in Temperature at Day 1, Day 8 and EOS EOS	-0.34 degrees Celsius Standard Deviation 0.47	0.16 degrees Celsius Standard Deviation 0.41

SECONDARY outcome

Timeframe: Part B randomization phase baseline and day 8, day 9 and EOS (week 12).

Population: The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab n=7 Participants Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at Day 8, Day 9 and EOS Day 8 (Pre-PACAP-38 dose): ALP	-2.0 Units/Liter Standard Deviation 5.6	0.0 Units/Liter Standard Deviation 4.8
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at Day 8, Day 9 and EOS Day 9 (Post-PACAP-38 dose): ALP	-1.6 Units/Liter Standard Deviation 4.1	-0.3 Units/Liter Standard Deviation 2.3
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at Day 8, Day 9 and EOS EOS: ALP	1.0 Units/Liter Standard Deviation 12.3	6.1 Units/Liter Standard Deviation 9.6
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at Day 8, Day 9 and EOS Day 8 (Pre-PACAP-38 dose): ALT	-1.4 Units/Liter Standard Deviation 3.5	-3.0 Units/Liter Standard Deviation 4.2
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at Day 8, Day 9 and EOS Day 9 (Post-PACAP-38 dose): ALT	-2.1 Units/Liter Standard Deviation 3.5	-4.5 Units/Liter Standard Deviation 4.2
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at Day 8, Day 9 and EOS EOS: ALT	-2.0 Units/Liter Standard Deviation 4.7	3.1 Units/Liter Standard Deviation 9.4
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at Day 8, Day 9 and EOS Day 8 (Pre-PACAP-38 dose): AST	0.3 Units/Liter Standard Deviation 3.0	2.4 Units/Liter Standard Deviation 4.0
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at Day 8, Day 9 and EOS Day 9 (Post-PACAP-38 dose): AST	-0.8 Units/Liter Standard Deviation 2.7	-4.2 Units/Liter Standard Deviation 2.3
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at Day 8, Day 9 and EOS EOS: AST	0.3 Units/Liter Standard Deviation 5.1	-0.4 Units/Liter Standard Deviation 3.6

SECONDARY outcome

Timeframe: Part B randomization baseline and day 8, day 9 and EOS (week 12).

Population: The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab n=7 Participants Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Mean Change From Baseline in Total Bilirubin at Day 8, Day 9 and EOS Day 8 (Pre-PACAP-38 dose)	-0.4211 micromol/L Standard Deviation 3.6356	-1.4849 micromol/L Standard Deviation 0.8532
Mean Change From Baseline in Total Bilirubin at Day 8, Day 9 and EOS Day 9 (Post-PACAP-38 dose)	3.3229 micromol/L Standard Deviation 1.3971	-2.2980 micromol/L Standard Deviation 1.0300
Mean Change From Baseline in Total Bilirubin at Day 8, Day 9 and EOS EOS	0.0804 micromol/L Standard Deviation 3.0270	1.3191 micromol/L Standard Deviation 3.5099

SECONDARY outcome

Timeframe: Part B randomization baseline and day 8, day 9 and EOS (week 12).

Population: The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab n=7 Participants Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Mean Change From Baseline in Blood Urea at Day 8, Day 9 and EOS Day 8 (Pre-PACAP-38 dose)	0.0629 millimol/L (mmol/L) Standard Deviation 0.9274	-0.0524 millimol/L (mmol/L) Standard Deviation 0.5270
Mean Change From Baseline in Blood Urea at Day 8, Day 9 and EOS Day 9 (Post-PACAP-38 dose)	0.1501 millimol/L (mmol/L) Standard Deviation 0.7552	-0.5278 millimol/L (mmol/L) Standard Deviation 1.2592
Mean Change From Baseline in Blood Urea at Day 8, Day 9 and EOS EOS	-0.1961 millimol/L (mmol/L) Standard Deviation 0.7673	0.0570 millimol/L (mmol/L) Standard Deviation 1.1286

SECONDARY outcome

Timeframe: Part B randomization baseline and day 8, day 9 and EOS (week 12).

Population: The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab n=7 Participants Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Mean Change From Baseline in Creatine Kinase at Day 8, Day 9 and EOS Day 8 (Pre-PACAP-38 dose)	5.8 U/L Standard Deviation 21.0	-22.4 U/L Standard Deviation 51.5
Mean Change From Baseline in Creatine Kinase at Day 8, Day 9 and EOS Day 9 (Post-PACAP-38 dose)	-16.8 U/L Standard Deviation 9.1	-59.3 U/L Standard Deviation 65.7
Mean Change From Baseline in Creatine Kinase at Day 8, Day 9 and EOS EOS	8.1 U/L Standard Deviation 25.3	-24.9 U/L Standard Deviation 79.9

SECONDARY outcome

Timeframe: Part B randomization baseline and day 8, day 9 and EOS (week 12).

Population: The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab n=7 Participants Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Mean Change From Baseline in Creatinine at Day 8, Day 9 and EOS Day 8 (Pre-PACAP-38 dose)	-1.9890 micromol/L Standard Deviation 6.0835	-2.2526 micromol/L Standard Deviation 3.1121
Mean Change From Baseline in Creatinine at Day 8, Day 9 and EOS Day 9 (Post-PACAP-38 dose)	0.1450 micromol/L Standard Deviation 7.3859	-1.4733 micromol/L Standard Deviation 3.4367
Mean Change From Baseline in Creatinine at Day 8, Day 9 and EOS EOS	3.5151 micromol/L Standard Deviation 7.8109	-0.3457 micromol/L Standard Deviation 2.6598

SECONDARY outcome

Timeframe: Part B randomization baseline and day 8, day 9 and EOS (week 12).

Population: The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab n=7 Participants Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Mean Change From Baseline in Direct Bilirubin at Day 8, Day 9 and EOS Day 8 (Pre-PACAP-38 dose)	-0.0570 micromol/L Standard Deviation 1.2948	-1.0260 micromol/L Standard Deviation NA Only 1 participant was analysed for this timepoint.
Mean Change From Baseline in Direct Bilirubin at Day 8, Day 9 and EOS Day 9 (Post-PACAP-38 dose)	0.6270 micromol/L Standard Deviation 0.5497	-1.1115 micromol/L Standard Deviation 0.1209
Mean Change From Baseline in Direct Bilirubin at Day 8, Day 9 and EOS EOS	0.1710 micromol/L Standard Deviation 0.1710	1.1970 micromol/L Standard Deviation 0.0000

SECONDARY outcome

Timeframe: Part B randomization baseline and day 8, day 9 and EOS (week 12).

Population: The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab n=7 Participants Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Mean Change From Baseline in Eosinophil Count at Day 8, Day 9 and EOS Day 8 (Pre-PACAP-38 dose)	-0.013 10^9/L Standard Deviation 0.067	-0.004 10^9/L Standard Deviation 0.046
Mean Change From Baseline in Eosinophil Count at Day 8, Day 9 and EOS Day 9 (Post-PACAP-38 dose)	-0.035 10^9/L Standard Deviation 0.076	-0.002 10^9/L Standard Deviation 0.066
Mean Change From Baseline in Eosinophil Count at Day 8, Day 9 and EOS EOS	-0.041 10^9/L Standard Deviation 0.060	0.033 10^9/L Standard Deviation 0.061

SECONDARY outcome

Timeframe: Part B randomization baseline and day 8, day 9 and EOS (week 12).

Population: The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab n=7 Participants Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Mean Change From Baseline in Blood Glucose at Day 8, Day 9 and EOS Day 8 (Pre-PACAP-38 dose)	-0.1360 mmol/L Standard Deviation 0.3103	-0.2761 mmol/L Standard Deviation 0.5961
Mean Change From Baseline in Blood Glucose at Day 8, Day 9 and EOS Day 9 (Post-PACAP-38 dose)	-0.2290 mmol/L Standard Deviation 0.2350	0.0427 mmol/L Standard Deviation 0.2432
Mean Change From Baseline in Blood Glucose at Day 8, Day 9 and EOS EOS	-0.3183 mmol/L Standard Deviation 0.3395	-0.1237 mmol/L Standard Deviation 0.3645

SECONDARY outcome

Timeframe: Part B randomization baseline and day 8, day 9 and EOS (week 12).

Population: The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab n=7 Participants Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Mean Change From Baseline in Hemoglobin A1C (Fraction of 1) at Day 8, Day 9 and EOS Day 8 (Pre-PACAP-38 dose)	0.0003 fraction of 1 Standard Deviation 0.0007	0.0001 fraction of 1 Standard Deviation 0.0007
Mean Change From Baseline in Hemoglobin A1C (Fraction of 1) at Day 8, Day 9 and EOS Day 9 (Post-PACAP-38 dose)	0.0000 fraction of 1 Standard Deviation 0.0005	0.0002 fraction of 1 Standard Deviation 0.0010
Mean Change From Baseline in Hemoglobin A1C (Fraction of 1) at Day 8, Day 9 and EOS EOS	0.0003 fraction of 1 Standard Deviation 0.0012	0.0002 fraction of 1 Standard Deviation 0.0012

SECONDARY outcome

Timeframe: Part B randomization phase 1 hour post-dose day 1.

Population: The PK Analysis Set consisted of all randomized participants who received erenumab and have at least 1 PK concentration result.

The mean serum erenumab concentration at 1 hour post-dose on day 1 of Part B randomization phase is presented.

Outcome measures

Measure	Placebo n=7 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Pharmacokinetics (PK): Mean Erenumab Serum Concentration at 1 Hour (C1h)	51.2 micrograms per milliliter (mcg/mL) Standard Deviation 9.72	—

SECONDARY outcome

Timeframe: Part B randomization phase baseline and 84 days post-dose.

Population: The PK Analysis Set consisted of all randomized participants who received erenumab and have at least 1 PK concentration result.

The mean AUC84d for erenumab for the Part B randomization phase is presented.

Outcome measures

Measure	Placebo n=7 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
PK: Mean Area Under the Concentration-time Curve From Time 0 to 84 Days Post-dose (AUC84d)	877 day*mcg/mL Standard Deviation 131	—

SECONDARY outcome

Timeframe: Part B randomization phase baseline and EOS.

Population: The Safety Analysis Set for erenumab consisted of all randomized participants who received at least 1 dose of erenumab in Part B.

Participants were tested for binding antibodies and neutralizing antibodies at baseline and following treatment with erenumab.

Outcome measures

Measure	Placebo n=7 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Number of Participants With Anti-Erenumab Antibodies Binding antibody positive at/before baseline	0 Participants	—
Number of Participants With Anti-Erenumab Antibodies Neutralizing antibody positive at/before baseline	0 Participants	—
Number of Participants With Anti-Erenumab Antibodies Binding antibody positive post-baseline	0 Participants	—
Number of Participants With Anti-Erenumab Antibodies Neutralizing antibody positive post-baseline	0 Participants	—

SECONDARY outcome

Timeframe: Part B randomization phase baseline and EOS.

Population: The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab n=7 Participants Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Part B randomization phase baseline and EOS.

Population: The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab n=7 Participants Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Number of Participants With Clinically Significant Changes in Physical Parameters	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Part B randomization phase baseline and EOS.

Population: The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B.

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.

Outcome measures

Measure	Placebo n=9 Participants Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.	Erenumab n=7 Participants Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. 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.
Number of Participants With Clinically Significant Changes in Neurological Assessments	0 Participants	0 Participants

Adverse Events

Placebo Day 1-7

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Erenumab Day 1-7

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Day 8-EOS

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Erenumab Day 8-EOS

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo Day 1-7 n=9 participants at risk Participants were randomized to receive matching erenumab placebo intravenously over 30 minutes on study day 1 of Part B randomization phase.	Erenumab Day 1-7 n=7 participants at risk Participants were randomized to receive 140 mg erenumab intravenously over 30 minutes on study day 1 of Part B randomization phase.	Placebo Day 8-EOS n=9 participants at risk On day 8 of Part B randomization phase, participants were administered 100 pmol/kg of PACAP-38, having received matching erenumab placebo on day 1. Participants were followed up for 11 weeks to EOS.	Erenumab Day 8-EOS n=7 participants at risk On day 8 of Part B randomization phase, participants were administered 100 pmol/kg of PACAP-38, having received 140 mg erenumab intravenously on day 1. Participants were followed up for 11 weeks to EOS.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Cardiac disorders Cardiac discomfort	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	14.3% 1/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Cardiac disorders Palpitations	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	55.6% 5/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	71.4% 5/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Ear and labyrinth disorders Hyperacusis	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Eye disorders Eye irritation	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Eye disorders Lacrimation increased	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	28.6% 2/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Eye disorders Ocular discomfort	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	14.3% 1/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Eye disorders Photophobia	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	14.3% 1/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	22.2% 2/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Gastrointestinal disorders Diarrhoea	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastritis	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	14.3% 1/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Gastrointestinal disorders Nausea	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	22.2% 2/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	14.3% 1/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
General disorders Catheter site pain	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
General disorders Chest discomfort	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	14.3% 1/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
General disorders Discomfort	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
General disorders Fatigue	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	44.4% 4/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	71.4% 5/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
General disorders Feeling cold	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	28.6% 2/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
General disorders Feeling hot	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	33.3% 3/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	28.6% 2/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
General disorders Hunger	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	14.3% 1/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
General disorders Malaise	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
General disorders Pain	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
General disorders Pyrexia	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	14.3% 1/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
General disorders Thirst decreased	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Infections and infestations Bacterial infection	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Infections and infestations Cystitis	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	14.3% 1/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Infections and infestations Gastroenteritis	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Infections and infestations Nasopharyngitis	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Infections and infestations Upper respiratory tract infection	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Concussion	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Contusion	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Joint lock	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	14.3% 1/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Nervous system disorders Disturbance in attention	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Nervous system disorders Dizziness	22.2% 2/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Nervous system disorders Head discomfort	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	44.4% 4/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	14.3% 1/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Nervous system disorders Headache	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	66.7% 6/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	42.9% 3/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Nervous system disorders Hypoaesthesia	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Nervous system disorders Migraine	33.3% 3/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	66.7% 6/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	100.0% 7/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Nervous system disorders Paraesthesia	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	14.3% 1/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Renal and urinary disorders Leukocyturia	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Cough	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	11.1% 1/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	14.3% 1/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	14.3% 1/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	22.2% 2/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	14.3% 1/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.
Vascular disorders Flushing	0.00% 0/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	77.8% 7/9 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.	85.7% 6/7 • From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks). Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: medinfo@amgen.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER