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AMG 334 · 1 trial · 3 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.
| 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...
AMG 334 is an investigational small molecule being developed for the prophylactic treatment of persistent post-traumatic headache, a condition that can follow mild traumatic brain injury and post-concussion syndrome. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
AMG 334 targets the calcitonin gene-related peptide (CGRP) receptor, which is involved in pain transmission and is a validated target for migraine and headache disorders. By blocking this receptor, the drug aims to prevent the onset of headache episodes in patients with persistent post-traumatic headache.
AMG 334 is developed by Amgen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol AMGN. Amgen is conducting clinical trials to evaluate the drug's efficacy and safety in patients with post-traumatic headache.
AMG 334 is in Phase 2 clinical development. A Phase 2 trial has been completed, but the drug remains investigational and is not yet approved for any use. Further studies may be needed to confirm its safety and efficacy before regulatory submission.
AMG 334 has one completed Phase 2 trial registered as NCT03974360, titled 'Efficacy and Tolerability of Erenumab in the Prophylactic Treatment of Persistent Post-Traumatic Headache.' The trial enrolled 100 participants in Denmark and included patients with post-traumatic headache, mild traumatic brain injury, and post-concussion syndrome.
Yes, AMG 334 is also known as erenumab. The clinical trial NCT03974360 refers to the drug as erenumab, confirming that AMG 334 and erenumab are the same compound. This name is used in the context of its evaluation for post-traumatic headache prophylaxis.