Phase 1b/2a Clinical Trial in Early Acute Spinal Cord Injury (SCI): a Single Blinded, Randomized, Proof-of-Concept Study to Determine the Safety, Tolerability and Efficacy of TZ-161
Technophage identified a promising compound, Eletriptan hydrobromide, that intends to use as a repurposed drug, for the treatment of acute spinal cord injury (SCI) in human subjects. Eletriptan hydrobromide is a well characterized molecule, that has been clinically available for over two decades for the treatment of migraines. It presents a good and manageable safety profile, including for the regimen selected for this trial, and it is generally well tolerated, with minimal side effects. This is an important consideration to have when using repurposed drugs for the treatment of other indications. Technophage believes that the preclinical data collected, in combination with the acceptable safety profile of Eletriptan hydrobromide, support its use as a repurposed drug for the treatment of SCI in humans.
• Subjects aged 18-65 years old.
• Subjects with clinical diagnosis of acute SCI that comply with the following:
‣ Injury located on the thoracic region (T1 to T12).
⁃ With clinical suspicion of a single traumatic (contusion) lesion.
⁃ AIS grade of grade B, C or D with a motor score less than or equal to 3 in at least one key muscle of a lower limb.
⁃ Ability to perform injury-to-drug administration ≤ 24 hours after SCI.
• Subjects willing and able to provide an informed consent.
• Subjects willing and able to complete the study and comply with instructions. The use of Relert in the elderly is not recommended, due to the fact that the safety and effectiveness of Eletriptan HBr in patients over 65 years of age had not been systematically evaluated, as a consequence of the small number of patients in this age group in clinical trials.