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RECRUITING
NCT06677229
PHASE1/PHASE2

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

Sponsor: Technophage, SA

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2025-08-01

Completion Date

2027-06

Last Updated

2025-09-09

Healthy Volunteers

No

Interventions

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.

Locations (2)

Hospital Universitario Reina Sofia

Córdoba, Spain

Hospital Universitario La Paz

Madrid, Spain