MigrainePhase 1NCT03499119

AMG 334 20160172 Pediatric Migraine PK Study.

A Phase 1 study testing AMG 334 Dose 1, AMG 334 Dose 2 and AMG 334 Dose 3 in people with Migraine, run by Amgen at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

AMG 334 20160172 Pediatric Migraine PK Study. Read more about this study

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Migraine
What is being tested?: AMG 334 Dose 1, AMG 334 Dose 2 and AMG 334 Dose 3
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 14 sitesUnited States
Study dates: 4 May 2018to 23 Nov 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Subject's legally acceptable representative has provided informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
Male and female children and adolescents ≥ 6 and <18 years of age upon entry into screening
Diagnosis of migraines, with or without aura, according to the International Classification of Headache Disorders (ICHD 3rd Edition, 2013) for at least 12 months prior to the study screening
Frequency of migraine of ≥ 4 migraine days per month in each of the 3 months prior to the study screening period

Who cannot join

Currently receiving treatment in another investigational device or drug study
History of migraine with brainstem aura or hemiplegic migraine headache
Medical history or other condition that compromises the ability of the subject or legally acceptable representative to give appropriate informed consent and/or assent
Malignancy except non-melanoma skin cancers or cervical cancer in situ within the last 5 years.
Presence of any clinical condition that in opinion of the investigator might increased the risk of subjects participating in the study.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Dent Neurosciences Research Center
Amherst, New York, 14226
PANDA Neurology and Atlanta Headache Specialists
Atlanta, Georgia, 30328
Synergy Health
Bradenton, Florida, 34208
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Childrens Hospital
Columbus, Ohio, 43205
CarePoint
Englewood, Colorado, 80112
Meridian Clinical Research
Hastings, Nebraska, 68901
Riley Hosptial
Indianapolis, Indiana, 46202
Childrens Mercy Hospital
Kansas City, Missouri, 64108
Arkansas Childrens Hospital
Little Rock, Arkansas, 72202
Clinical Research Institute Inc
Plymouth, Minnesota, 55441
New England Institute for Clinical Research
Stamford, Connecticut, 06905
State University of New York Upstate Medical University
Syracuse, New York, 13210
Premiere Research Institute
West Palm Beach, Florida, 33407

Other trials in United States

About this study

Official title: A Phase I, Randomized, Open-label, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine

AMG 334 20160172 Pediatric Migraine PK Study.

Read the detailed description

An Open-label, Randomized, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine

Conditions: Migraine
Being tested: AMG 334 Dose 1, AMG 334 Dose 2, AMG 334 Dose 3
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AMG 334 Dose 1Drug
Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3.
Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2
AMG 334 Dose 2Drug
Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2.
AMG 334 Dose 3Drug
Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3.

Study groups in NCT03499119
Study group	Role	What they receive
Cohort 1	Other	Subjects with a body weight at Day 1 of less than weight threshold. Receives: Drug: AMG 334 Dose 1; Drug: AMG 334 Dose 3
Cohort 2	Other	Subjects with a body weight at Day 1 of weight threshold or more. Receives: Drug: AMG 334 Dose 1; Drug: AMG 334 Dose 2

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Maximum Concentration (Tmax) of Erenumab
Blood samples for pharmacokinetic (PK) testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. Noncompartmental analysis (NCA) was performed for erenumab PK parameter estimation.
Measured: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85
Maximum Observed Concentration (Cmax) of Erenumab
Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation.
Measured: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85
Trough Concentration (Ctrough) of Erenumab
Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation.
Measured: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85
Area Under the Concentration Time Curve From 0 to 28 Days (AUC0-28day) of Erenumab
Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation.
Measured: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant. A TEAE was defined as an AE starting on or after first dose of investigational product. The event did not necessarily have a causal relationship with study treatment.
Measured: Up to Week 52 + 16-week safety follow-up
Number of Participants With Clinically Significant Changes in Vital Signs Measurements
The following measurements were performed: systolic/diastolic blood pressure, heart rate, and temperature.
Measured: Up to Week 52 + 16-week safety follow-up
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements
Clinically significant changes in ECG was defined as incidence of abnormal ECG diagnosis based on 12-lead ECG including heart rate, QRS, QTc and PR intervals.
Measured: Up to Week 52
Number of Participants With Clinically Significant Changes in Clinical Laboratory Safety Tests
The clinical laboratory safety tests included: chemistry, hematology, and urinalysis.
Measured: Up to Week 52 + 16-week safety follow-up
Number of Participants With Clinically Significant Changes in Neurological Assessments
The neurological examinations were completed as per standard of care.
Measured: Up to Week 52 + 16-week safety follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 May 201823 Nov 2021

First posted17 Apr 2018
Study start4 May 2018
Primary completion23 Nov 2021
Study completion23 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MigraineStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03499119
Sponsor's protocol ID: 20160172
Status last verified: May 2024
First submitted: 7 Mar 2018
Last updated: 28 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Publications

Hershey AD, Paiva da Silva Lima G, Pannacciulli N, Mackowski M, Koukakis R, McVige JW. Pharmacokinetics and safety of erenumab in pediatric patients with migraine: A phase I, randomized, open-label, multiple-dose study. Clin Transl Sci. 2024 Mar;17(3):e13755. doi: 10.1111/cts.13755.
PubMed 38476099

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Recruiting
Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain
Migraine, Migraine in Adolescence

All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomized, Open-label, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine
ClinicalTrials.gov ID: NCT03499119
Acronym / sponsor ID: 20160172
Conditions: Migraine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 4 May 2018 (actual)
Primary completion: 23 Nov 2021 (actual)
Study completion: 23 Nov 2021 (actual)
First posted: 17 Apr 2018 (actual)
Results: Posted 28 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

AMG 334 20160172 Pediatric Migraine PK Study.

Detailed description

An Open-label, Randomized, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1	Other	Drug: AMG 334 Dose 1, Drug: AMG 334 Dose 3Subjects with a body weight at Day 1 of less than weight threshold.
Cohort 2	Other	Drug: AMG 334 Dose 1, Drug: AMG 334 Dose 2Subjects with a body weight at Day 1 of weight threshold or more.

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Subject's legally acceptable representative has provided informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
Male and female children and adolescents ≥ 6 and <18 years of age upon entry into screening
Diagnosis of migraines, with or without aura, according to the International Classification of Headache Disorders (ICHD 3rd Edition, 2013) for at least 12 months prior to the study screening
Frequency of migraine of ≥ 4 migraine days per month in each of the 3 months prior to the study screening period

Key exclusion criteria (5 listed)

Currently receiving treatment in another investigational device or drug study
History of migraine with brainstem aura or hemiplegic migraine headache
Medical history or other condition that compromises the ability of the subject or legally acceptable representative to give appropriate informed consent and/or assent
Malignancy except non-melanoma skin cancers or cervical cancer in situ within the last 5 years.
Presence of any clinical condition that in opinion of the investigator might increased the risk of subjects participating in the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AMG 334 Dose 1Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3. Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2	Drug	Cohort 1, Cohort 2
AMG 334 Dose 2Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2.	Drug	Cohort 2
AMG 334 Dose 3Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3.	Drug	Cohort 1

Primary outcome

Time to Maximum Concentration (Tmax) of Erenumab
Time frame: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85
Blood samples for pharmacokinetic (PK) testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. Noncompartmental analysis (NCA) was performed for erenumab PK parameter estimation.
Maximum Observed Concentration (Cmax) of Erenumab
Time frame: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85
Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation.
Trough Concentration (Ctrough) of Erenumab
Time frame: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85
Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation.
Area Under the Concentration Time Curve From 0 to 28 Days (AUC0-28day) of Erenumab
Time frame: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85
Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Week 52 + 16-week safety follow-up
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant. A TEAE was defined as an AE starting on or after first dose of investigational product. The event did not necessarily have a causal relationship with study treatment.
Number of Participants With Clinically Significant Changes in Vital Signs Measurements
Time frame: Up to Week 52 + 16-week safety follow-up
The following measurements were performed: systolic/diastolic blood pressure, heart rate, and temperature.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements
Time frame: Up to Week 52
Clinically significant changes in ECG was defined as incidence of abnormal ECG diagnosis based on 12-lead ECG including heart rate, QRS, QTc and PR intervals.
Number of Participants With Clinically Significant Changes in Clinical Laboratory Safety Tests
Time frame: Up to Week 52 + 16-week safety follow-up
The clinical laboratory safety tests included: chemistry, hematology, and urinalysis.
Number of Participants With Clinically Significant Changes in Neurological Assessments
Time frame: Up to Week 52 + 16-week safety follow-up
The neurological examinations were completed as per standard of care.

Results and safety

Results posted to the registry on 28 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Erenumab 35 mg	4	3
Cohort 1: Erenumab 70 mg	9	9
Cohort 2: Erenumab 70 mg	8	7
Cohort 2: Erenumab 140 mg	32	29

Primary outcome: Time to Maximum Concentration (Tmax) of Erenumab

Time frame: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85. Median (Full Range). Unit: days

Measure	Cohort 1: Erenumab 35 mg n = 3	Cohort 1: Erenumab 70 mg n = 9	Cohort 2: Erenumab 70 mg n = 8	Cohort 2: Erenumab 140 mg n = 30
First Dose	7.0 (2.9 to 7.2)	7.0 (2.9 to 14.0)	9.0 (2.9 to 15.0)	7.0 (2.9 to 16.0)
Third Dose	7.2 (7.0 to 8.0)	10.0 (7.0 to 21.0)	9.0 (6.0 to 26.0)	7.2 (4.0 to 15.0)

Population analysed: The PK analysis set contained all randomized participants who received at least 1 dose of erenumab and had at least 1 PK concentration result. Data were excluded from the NCA if: * participants missed the previous dose or the actual time deviated by \> 30% from the nominal sample collection time * PK profile was missing \> 2 samples * PK values at the beginning or end of PK profile were missing, or * predose PK sample concentration was \> 5% of maximum concentration value.

Primary outcome: Maximum Observed Concentration (Cmax) of Erenumab

Time frame: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85. Mean (Standard Deviation). Unit: μg/mL

Measure	Cohort 1: Erenumab 35 mg n = 3	Cohort 1: Erenumab 70 mg n = 9	Cohort 2: Erenumab 70 mg n = 8	Cohort 2: Erenumab 140 mg n = 30
First Dose	7.92 (0.947)	13.3 (4.85)	7.16 (1.76)	13.4 (4.53)
Third Dose	11.3 (3.14)	18.9 (7.29)	14.1 (5.54)	23.7 (8.83)

Primary outcome: Trough Concentration (Ctrough) of Erenumab

Time frame: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85. Mean (Standard Deviation). Unit: μg/mL

Measure	Cohort 1: Erenumab 35 mg n = 3	Cohort 1: Erenumab 70 mg n = 9	Cohort 2: Erenumab 70 mg n = 8	Cohort 2: Erenumab 140 mg n = 31
First Dose	3.92 (0.626)	7.02 (2.85)	4.23 (1.05)	7.77 (2.79)
Third Dose	5.43 (0.861)	10.3 (5.47)	9.81 (2.37)	14.9 (5.87)

Primary outcome: Area Under the Concentration Time Curve From 0 to 28 Days (AUC0-28day) of Erenumab

Time frame: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85. Median (Full Range). Unit: day*μg/mL

Measure	Cohort 1: Erenumab 35 mg n = 3	Cohort 1: Erenumab 70 mg n = 6	Cohort 2: Erenumab 70 mg n = 6	Cohort 2: Erenumab 140 mg n = 21
First Dose	175 (165 to 185)	282 (65.8 to 357)	151 (112 to 192)	277 (175 to 551)
Third Dose	243 (176 to 269)	465 (336 to 667)	329 (180 to 437)	475 (259 to 1000)

Adverse events

Time frame: Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Initial Treatment Phase Cohort 1: Erenumab 35 mg	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Initial Treatment Phase Cohort 1: Erenumab 70 mg	0 of 9 (0%)	6 of 9 (66.7%)	0 of 9
Initial Treatment Phase Cohort 2: Erenumab 70 mg	1 of 8 (12.5%)	6 of 8 (75%)	0 of 8
Initial Treatment Phase Cohort 2: Erenumab 140 mg	1 of 32 (3.1%)	19 of 32 (59.4%)	0 of 32
Optional Extension Phase Cohort 1: Erenumab 35 mg	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Optional Extension Phase Cohort 1: Erenumab 70 mg	1 of 3 (33.3%)	2 of 3 (66.7%)	0 of 3
Optional Extension Phase Cohort 2: Erenumab 70 mg	0 of 5 (0%)	4 of 5 (80%)	0 of 5
Optional Extension Phase Cohort 2: Erenumab 140 mg	1 of 27 (3.7%)	19 of 27 (70.4%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 38476099Hershey AD, Paiva da Silva Lima G, Pannacciulli N, Mackowski M, Koukakis R, McVige JW. Pharmacokinetics and safety of erenumab in pediatric patients with migraine: A phase I, randomized, open-label, multiple-dose study. Clin Transl Sci. 2024 Mar;17(3):e13755. doi: 10.1111/cts.13755.
AmgenTrials clinical trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Related trials for Migraine

Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Recruiting
Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain
Migraine, Migraine in Adolescence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMG 334 Dose 1, AMG 334 Dose 2 and AMG 334 Dose 3 in people with Migraine, run by Amgen at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Maximum Concentration (Tmax) of Erenumab (time frame: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03499119, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.