Phase 1
N=53
AMG 334 20160172 Pediatric Migraine PK Study.
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT03499119 ↗Enrolled (actual)
53
Serious AEs
4.5%
Results posted
Mar 2024
Primary outcome: Primary: Time to Maximum Concentration (Tmax) of Erenumab — 7.0; 7.0; 9.0; 7.0 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- AMG 334 Dose 1 (Drug); AMG 334 Dose 2 (Drug); AMG 334 Dose 3 (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Maximum Concentration (Tmax) of Erenumab |
7.0; 7.0; 9.0; 7.0; 7.2; 10.0 | — |
| PRIMARY Maximum Observed Concentration (Cmax) of Erenumab |
7.92; 13.3; 7.16; 13.4; 11.3; 18.9 | — |
| PRIMARY Trough Concentration (Ctrough) of Erenumab |
3.92; 7.02; 4.23; 7.77; 5.43; 10.3 | — |
| PRIMARY Area Under the Concentration Time Curve From 0 to 28 Days (AUC0-28day) of Erenumab |
175; 282; 151; 277; 243; 465 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
2; 6; 6; 28 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Vital Signs Measurements |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Clinical Laboratory Safety Tests |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Neurological Assessments |
0; 0; 0; 0 | — |
Summary
AMG 334 20160172 Pediatric Migraine PK Study.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03499119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.