Phase 1b/2a Clinical Trial to Determine the Safety, Tolerability and Efficacy of TZ-161 in Spinal Cord Injury

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTechnophage, SA

About this trial

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.

Eligibility criteria

Qualifiers

Subjects aged 18-65 years old.

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.

Disqualifiers

Clinical or imaging suspicion of multi-lesion or extra-thoracic contusions on diagnostic CT scan and on MRI at 48H*.

Subjects in coma or with significant cognitive impairment in the opinion of the investigator.

Subjects presenting mechanical ventilation dependence.

Subjects with past medical history of any - structural - neurological disorder of the central or peripheral nervous system, including past spinal cord injury. Furthermore, subjects with spine/bone-related medical history (prior to SCI) that in the opinion of the investigator are not yet resolved or previous lesions that are located in the same area of the study SCI should also be excluded.

Trial design

Treatments tested in this trial

  • Eletriptan HBr 40 mg

Treatment groups

28 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Technophage, SA

Lead sponsor

VectorB2B

Collaborator