A Phase 1 interventional study of AMG 334 Dose 1 and AMG 334 Dose 2 in Migraine, sponsored by Amgen. Completed at 14 sites in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-05-28.
Sponsored by Amgen · Phase 1, Interventional, and Basic science
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Among 37 studies testing erenumab in Migraine Disorders — 3 open to participants now, 4 under way, 1 of them phase 3. erenumab · Migraine Disorders.
Among the 37 studies testing erenumab in Migraine Disorders, this one is the 28th largest by enrollment, is one of 2 that started in 2018, is one of 7 in phase 1, and was the 13th registered.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
Browse Migraine Disorders studies →3 of the 37 studies testing erenumab in Migraine Disorders are open now, in 1 country. Recruiting first, the newest first:
Danish Headache Center · Sites in Denmark
Ages 18+
Danish Headache Center · Sites in Denmark
Ages 18–50
Stanford University
Ages 18+
By country, each count listing its studies:
erenumab: first FDA approval 2018 (AIMOVIG), first EMA approval 2018. What it is approved for, and how studies give it, is on its page →
Of the 217 Migraine Disorders studies recruiting now, 66 (30%) set no upper age limit and 136 (63%) stop at 75 or younger; 44 take children under 18; 37 take healthy volunteers.
This study: 6 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
37 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 2 started in 2018.
This study's enrollment of 53 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Median enrollment 261 across the 37 interventional studies. Of the 29 that completed or were terminated, 28 (97%) have results posted.
This tab as a report to print or save as PDF → With an account.
29 of 37 have an industry lead sponsor. The 8 most frequent:
Amgen is the lead sponsor of 1,047 studies on the registry; 51 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 166 (67%) have results posted.
24 studies in Migraine Disorders by Amgen: 1 open now, 2 under way, 1 of them phase 3. Of 22 finished, 20 (91%) have results posted.
Among the 24 studies in Migraine Disorders by Amgen, this one is the 18th largest by enrollment of the 23 interventional ones that give a count, is the only one that started in 2018, is one of 7 in phase 1, and was the 14th registered.
Amgen’s Migraine Disorders studies by the year they started, since 2012.
None of the studies under way reaches primary completion within a year.
Among the 37 studies testing erenumab in Migraine Disorders, from their registry updates:
Among Amgen’s 24 in Migraine Disorders:
This tab as a report to print or save as PDF → With an account.
AMG 334 20160172 Pediatric Migraine PK Study.
An Open-label, Randomized, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with a body weight at Day 1 of less than weight threshold.
Drug: AMG 334 Dose 1 · Drug: AMG 334 Dose 3
Subjects with a body weight at Day 1 of weight threshold or more.
Drug: AMG 334 Dose 1 · Drug: AMG 334 Dose 2
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
Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2.
Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Week 52 + 16-week safety follow-up
Of the 63 participants screened, 53 participants were enrolled at 9 centers in the United States between 04 May 2018 and 23 November 2021. Enrollment was staggered by age category with adolescents 12 to \< 18 years of age starting enrollment first, followed by children 6 to \< 12 years of age.
| Milestone | Cohort 1: Erenumab 35 mg | Cohort 1: Erenumab 70 mg | Cohort 2: Erenumab 70 mg | Cohort 2: Erenumab 140 mg |
|---|---|---|---|---|
| Started | 4 | 9 | 8 | 32 |
| Completed | 3 | 9 | 7 | 29 |
| Not completed | 1 | 0 | 1 | 3 |
| Withdrew: Protocol specified criteria | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 |
| Withdrew: Decision by sponsor | 1 | 0 | 1 | 1 |
| Milestone | Cohort 1: Erenumab 35 mg | Cohort 1: Erenumab 70 mg | Cohort 2: Erenumab 70 mg | Cohort 2: Erenumab 140 mg |
|---|---|---|---|---|
| Started | 1 | 3 | 5 | 27 |
| Completed | 1 | 2 | 5 | 21 |
| Not completed | 0 | 1 | 0 | 6 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 5 |
| Withdrew: Protocol specified criteria | 0 | 1 | 0 | 0 |
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.
| days | Cohort 1: Erenumab 35 mg | Cohort 1: Erenumab 70 mg | Cohort 2: Erenumab 70 mg | Cohort 2: Erenumab 140 mg |
|---|---|---|---|---|
| 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) |
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.
| μg/mL | Cohort 1: Erenumab 35 mg | Cohort 1: Erenumab 70 mg | Cohort 2: Erenumab 70 mg | Cohort 2: Erenumab 140 mg |
|---|---|---|---|---|
| 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 |
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.
| μg/mL | Cohort 1: Erenumab 35 mg | Cohort 1: Erenumab 70 mg | Cohort 2: Erenumab 70 mg | Cohort 2: Erenumab 140 mg |
|---|---|---|---|---|
| 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 |
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.
| day*μg/mL | Cohort 1: Erenumab 35 mg | Cohort 1: Erenumab 70 mg | Cohort 2: Erenumab 70 mg | Cohort 2: Erenumab 140 mg |
|---|---|---|---|---|
| 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) |
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.
| Participants | Cohort 1: Erenumab 35 mg | Cohort 1: Erenumab 70 mg | Cohort 2: Erenumab 70 mg | Cohort 2: Erenumab 140 mg |
|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 2 | 6 | 6 | 28 |
The following measurements were performed: systolic/diastolic blood pressure, heart rate, and temperature.
| Participants | Cohort 1: Erenumab 35 mg | Cohort 1: Erenumab 70 mg | Cohort 2: Erenumab 70 mg | Cohort 2: Erenumab 140 mg |
|---|---|---|---|---|
| Number of Participants With Clinically Significant Changes in Vital Signs Measurements | 0 | 0 | 0 | 0 |
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.
| Participants | Cohort 1: Erenumab 35 mg | Cohort 1: Erenumab 70 mg | Cohort 2: Erenumab 70 mg | Cohort 2: Erenumab 140 mg |
|---|---|---|---|---|
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements | 0 | 0 | 0 | 0 |
The clinical laboratory safety tests included: chemistry, hematology, and urinalysis.
| Participants | Cohort 1: Erenumab 35 mg | Cohort 1: Erenumab 70 mg | Cohort 2: Erenumab 70 mg | Cohort 2: Erenumab 140 mg |
|---|---|---|---|---|
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Safety Tests | 0 | 0 | 0 | 0 |
The neurological examinations were completed as per standard of care.
| Participants | Cohort 1: Erenumab 35 mg | Cohort 1: Erenumab 70 mg | Cohort 2: Erenumab 70 mg | Cohort 2: Erenumab 140 mg |
|---|---|---|---|---|
| Number of Participants With Clinically Significant Changes in Neurological Assessments | 0 | 0 | 0 | 0 |
Collected over 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. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Initial Treatment Phase Cohort 1: Erenumab 35 mg | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) |
| Initial Treatment Phase Cohort 1: Erenumab 70 mg | 0/9 (0%) | 0/9 (0%) | 6/9 (66.7%) |
| Initial Treatment Phase Cohort 2: Erenumab 70 mg | 0/8 (0%) | 1/8 (12.5%) | 6/8 (75%) |
| Initial Treatment Phase Cohort 2: Erenumab 140 mg | 0/32 (0%) | 1/32 (3.1%) | 19/32 (59.4%) |
| Optional Extension Phase Cohort 1: Erenumab 35 mg | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Optional Extension Phase Cohort 1: Erenumab 70 mg | 0/3 (0%) | 1/3 (33.3%) | 2/3 (66.7%) |
| Optional Extension Phase Cohort 2: Erenumab 70 mg | 0/5 (0%) | 0/5 (0%) | 4/5 (80%) |
| Optional Extension Phase Cohort 2: Erenumab 140 mg | 0/27 (0%) | 1/27 (3.7%) | 19/27 (70.4%) |
| Event | Initial Treatment Phase Cohort 1: Erenumab 35 mg | Initial Treatment Phase Cohort 1: Erenumab 70 mg | Initial Treatment Phase Cohort 2: Erenumab 70 mg | Initial Treatment Phase Cohort 2: Erenumab 140 mg | Optional Extension Phase Cohort 1: Erenumab 35 mg | Optional Extension Phase Cohort 1: Erenumab 70 mg | Optional Extension Phase Cohort 2: Erenumab 70 mg | Optional Extension Phase Cohort 2: Erenumab 140 mg |
|---|---|---|---|---|---|---|---|---|
| Suicidal ideationPsychiatric disorders | 0/4 | 0/9 | 0/8 | 0/32 | 0/1 | 1/3 | 0/5 | 0/27 |
| Suicide attemptPsychiatric disorders | 0/4 | 0/9 | 1/8 | 0/32 | 0/1 | 0/3 | 0/5 | 0/27 |
| GastritisGastrointestinal disorders | 0/4 | 0/9 | 0/8 | 0/32 | 0/1 | 0/3 | 0/5 | 1/27 |
| AppendicitisInfections and infestations | 0/4 | 0/9 | 0/8 | 1/32 | 0/1 | 0/3 | 0/5 | 0/27 |
| Event | Initial Treatment Phase Cohort 1: Erenumab 35 mg | Initial Treatment Phase Cohort 1: Erenumab 70 mg | Initial Treatment Phase Cohort 2: Erenumab 70 mg | Initial Treatment Phase Cohort 2: Erenumab 140 mg | Optional Extension Phase Cohort 1: Erenumab 35 mg | Optional Extension Phase Cohort 1: Erenumab 70 mg | Optional Extension Phase Cohort 2: Erenumab 70 mg | Optional Extension Phase Cohort 2: Erenumab 140 mg |
|---|---|---|---|---|---|---|---|---|
| VomitingGastrointestinal disorders | 0/4 | 1/9 | 1/8 | 2/32 | 0/1 | 0/3 | 2/5 | 4/27 |
| Upper respiratory tract infectionInfections and infestations | 0/4 | 0/9 | 0/8 | 2/32 | 0/1 | 0/3 | 2/5 | 7/27 |
| HordeolumInfections and infestations | 0/4 | 0/9 | 0/8 | 0/32 | 0/1 | 1/3 | 0/5 | 0/27 |
| Skin irritationSkin and subcutaneous tissue disorders | 0/4 | 0/9 | 0/8 | 0/32 | 0/1 | 1/3 | 0/5 | 0/27 |
| Abdominal pain upperGastrointestinal disorders | 1/4 | 0/9 | 0/8 | 2/32 | 0/1 | 0/3 | 0/5 | 3/27 |
| Injection site painGeneral disorders | 1/4 | 1/9 | 1/8 | 0/32 | 0/1 | 0/3 | 0/5 | 0/27 |
| Injection site swellingGeneral disorders | 1/4 | 0/9 | 0/8 | 0/32 | 0/1 | 0/3 | 0/5 | 1/27 |
| InfluenzaInfections and infestations | 1/4 | 1/9 | 0/8 | 0/32 | 0/1 | 0/3 | 0/5 | 1/27 |
| Pharyngitis streptococcalInfections and infestations | 1/4 | 0/9 | 0/8 | 0/32 | 0/1 | 0/3 | 0/5 | 2/27 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 0/4 | 2/9 | 0/8 | 1/32 | 0/1 | 0/3 | 1/5 | 0/27 |
The full analysis set included all randomized participants.
| Age, Continuous(years) | Cohort 1: Erenumab 35 mg | Cohort 1: Erenumab 70 mg | Cohort 2: Erenumab 70 mg | Cohort 2: Erenumab 140 mg | Total |
|---|---|---|---|---|---|
| Mean | 10.8 ± 1.7 | 10.4 ± 1.0 | 14.6 ± 1.3 | 15.4 ± 1.5 | 14.1 ± 2.5 |
| Age, Customized(Participants) | Cohort 1: Erenumab 35 mg | Cohort 1: Erenumab 70 mg | Cohort 2: Erenumab 70 mg | Cohort 2: Erenumab 140 mg | Total |
|---|---|---|---|---|---|
| Children (6 to < 12 years) | 3 | 7 | 0 | 0 | 10 |
| Adolescents (12 to < 18 years) | 1 | 2 | 8 | 32 | 43 |
| Sex: Female, Male(Participants) | Cohort 1: Erenumab 35 mg | Cohort 1: Erenumab 70 mg | Cohort 2: Erenumab 70 mg | Cohort 2: Erenumab 140 mg | Total |
|---|---|---|---|---|---|
| Female | 1 | 3 | 4 | 23 | 31 |
| Male | 3 | 6 | 4 | 9 | 22 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1: Erenumab 35 mg | Cohort 1: Erenumab 70 mg | Cohort 2: Erenumab 70 mg | Cohort 2: Erenumab 140 mg | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 0 | 2 | 4 |
| Not Hispanic or Latino | 3 | 8 | 8 | 30 | 49 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Cohort 1: Erenumab 35 mg | Cohort 1: Erenumab 70 mg | Cohort 2: Erenumab 70 mg | Cohort 2: Erenumab 140 mg | Total |
|---|---|---|---|---|---|
| Black (or African American) | 0 | 2 | 1 | 4 | 7 |
| Multiple | 0 | 0 | 0 | 2 | 2 |
| White | 4 | 6 | 7 | 26 | 43 |
| Other | 0 | 1 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Data sharing details ↗ · www.amgen.com
Ran from May 2018 to primary completion in Nov 2021, 42 months.
Results were first posted in Mar 2024, 2 years 4 months after primary completion.
Of 39 industry-sponsored phase 1 interventional studies under Migraine Disorders, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 12. This study's 42 months is above that.
Counting every sponsor, half of 53 studies reached it within 6 months; a quarter within 2 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Erenumab