NCT06677229

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Technophage, SA · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Eletriptan hydrobromide (HBr) is a second-generation serotonin (5-HT) receptor agonist with high affinity for 5-HT1B, 5-HT1D and 5-HT1F receptors approved for the acute treatment of the headache phase of migraine attacks, with or without aura. 5-HT is a monoamine neurotransmitter synthesized in several subpopulations of brainstem neurons and plays an important role in vertebrate locomotion. Following spinal cord injury (SCI) there is a disruption of descending serotonergic projections to spinal motor areas, which results in a subsequent 5-HT depletion, 5-HT transporter dysregulation, as well as elevated expression, hyper-sensitivity and/or constitutive auto-activation of specific 5-HT receptors. Technophage identified a new possible therapeutic indication for Eletriptan HBr, showing its locomotor recovery properties in two different animal models of injury. Based on preclinical findings, Technophage intends to test Eletriptan HBr in the clinical environment, as a repurposed drug, for the treatment of acute SCI in human subjects.

Conditions

• Acute Spinal Cord Injury (SCI)

Interventions

Type	Name	Description
DRUG	Eletriptan HBr 40 mg	Oral administration of Eletriptan HBr in the form of tablets, 40 mg once daily (q.d.) for a total of 6 days, together with their usual SOC treatment.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2024-11-06
• Last updated: 2025-09-09

Locations

2 sites across 1 country: Spain