Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03499119 | AMG 334 20160172 Pediatric Migraine PK Study. | PHASE1 | COMPLETED | 53 | — | — | May 4, 2018 | Nov 23, 2021 | May 28, 2024 | 14 | United States |
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.
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.
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.
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.
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.
The following measurements were performed: systolic/diastolic blood pressure, heart rate, and temperature.
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.
The clinical laboratory safety tests included: chemistry, hematology, and urinalysis.
The neurological examinations were completed as per standard of care.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | OTHER | Subjects with a body weight at Day 1 of less than weight threshold. |
| Cohort 2 | OTHER | Subjects with a body weight at Day 1 of weight threshold or more. |
| Name | Type | Description |
|---|---|---|
| AMG 334 Dose 1 | DRUG | 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 2 | DRUG | Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2. |
| AMG 334 Dose 3 | DRUG | Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3. |
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 ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 15 | PHASE3 | Atogepant, Topiramate, Ubrogepant, MEDI0618 |
| Pfizer Inc. | PFE | 9 | PHASE3 | Rimegepant, Rimegepant/BHV3000, Zavegepant, Various, Rimegepant for acute migraine treatment |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Galcanezumab |
| Amgen Inc. | AMGN | 2 | PHASE3 | Erenumab Dose 1, erenumab-aooe |
| Ki Health Partners. LLC | RVNC | 1 | — | Daxibotulinumtonix A |