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Also known as AMG 334
AMG 334 Dose 1 · 2 trials · 4 indications
To evaluate the effect of erenumab on change in the monthly average number of headache days with moderate or severe intensity from baseline to week 9-12 in patients with persistent post-traumatic headache (PPTH). The assessment will be made using a headache diary.
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 |
|---|---|---|
| Erenumab | EXPERIMENTAL | 100 subjects with persistent post-traumatic headache will be allocated to receive monthly subcutaneous injections of 140 mg erenumab at three time points (week 0, week 4, week 8) |
| 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 | DRUG | 100 subjects with persistent post-traumatic headache will be allocated to receive monthly subcutaneous injections of 140 mg erenumab at three time points (week 0, week 4, week 8) |
| 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: * Men and women between 18 - 65 years who suffer from PPTH following a concussion / mild traumatic brain injury more than 12 months ago. * Fertile women must use safe contraceptives and present with a negative u-HCG on the experimental day. Safe contraceptives are defined as int...
AMG 334 Dose 1 is an investigational small molecule being developed by Amgen Inc. for migraine and post-traumatic headache. It is in Phase 1 clinical development. The program includes a completed Phase 1 pediatric migraine pharmacokinetic study and a completed Phase 2 study in persistent post-traumatic headache.
AMG 334 Dose 1 is being studied for migraine and post-traumatic headache. One completed trial evaluated it for the prophylactic treatment of persistent post-traumatic headache in adults with mild traumatic brain injury or post-concussion syndrome, and another completed Phase 1 study evaluated pharmacokinetics in pediatric migraine patients.
Amgen Inc. (ticker AMGN) is the developer of AMG 334 Dose 1. The company sponsors the clinical program, which includes a completed Phase 1 pediatric migraine pharmacokinetic study and a completed Phase 2 study in persistent post-traumatic headache.
AMG 334 Dose 1 is in Phase 1 development. It is investigational and has not been approved. The program includes one completed Phase 1 pediatric migraine pharmacokinetic study and one completed Phase 2 study in persistent post-traumatic headache, with no trials currently active.
AMG 334 Dose 1 has been studied in two completed trials. NCT03499119 was a Phase 1 pediatric migraine pharmacokinetic study in the United States with 53 participants. NCT03974360 was a Phase 2 study of erenumab for prophylactic treatment of persistent post-traumatic headache in Denmark with 100 participants.
Yes, AMG 334 Dose 1 is also known as AMG 334. Both names refer to the same Amgen Inc. (AMGN) investigational program being studied in migraine and post-traumatic headache. The Phase 1 pediatric migraine pharmacokinetic study is titled AMG 334 20160172.