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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03974360 | Efficacy and Tolerability of Erenumab in the Prophylactic Treatment of Persistent Post-Traumatic Headache | PHASE2 | COMPLETED | 100 | — | — | Apr 5, 2019 | Dec 31, 2019 | Feb 10, 2020 | 1 | Denmark |
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.
| 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) |
| 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) |
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...