Actively Recruiting
Phase 1b/2a Clinical Trial to Determine the Safety, Tolerability and Efficacy of TZ-161 in Spinal Cord Injury
Led by Technophage, SA · Updated on 2025-09-09
28
Participants Needed
2
Research Sites
95 weeks
Total Duration
On this page
Sponsors
T
Technophage, SA
Lead Sponsor
V
VectorB2B
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 1b/2a Clinical Trial to Determine the Safety, Tolerability and Efficacy of TZ-161 in Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged 18-65 years old
- Clinical diagnosis of acute spinal cord injury located in the thoracic region (T1 to T12)
- Single traumatic (contusion) lesion suspected
- AIS grade B, C, or D with motor score ≤ 3 in at least one key lower limb muscle
- Ability to receive drug administration within 24 hours after SCI
- Willing and able to provide informed consent
- Willing and able to complete the study and follow instructions
You will not qualify if you...
- Clinical or imaging suspicion of multi-lesion or extra-thoracic contusions
- Coma or significant cognitive impairment
- Dependence on mechanical ventilation
- Past medical history of structural neurological disorders or prior spinal cord injury
- Spine or bone-related medical issues unresolved or in the SCI area
- Dysphagia or inability to swallow tablets
- Pregnancy or breastfeeding; pregnancy excluded by negative blood test
- Active malignancy or malignancy treated in last 5 years with prohibited medication
- Recent use of Eletriptan HBr within 24 hours
- Significant ECG abnormalities including Wolff-Parkinson-White syndrome
- Contraindications or precautions per Eletriptan HBr safety profile (e.g., ischemic heart disease, stroke history, uncontrolled hypertension, recent use of serotonin receptor agonists, or interacting medications)
- Use of medications inhibiting CYP3A4 or interacting drugs within 72 hours
- Known liver disease beyond Child Pugh A or severe hepatic impairment
- Known renal disease or severe impairment (eGFR below 50 ml/min)
- Participation in another study within last 3 months or planned during this trial
- Presence of foreign magnetic metal bodies or conditions preventing MRI
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Hospital Universitario Reina Sofia
Córdoba, Spain
Actively Recruiting
2
Hospital Universitario La Paz
Madrid, Spain
Actively Recruiting
Research Team
S
Sofia Corte-Real
CONTACT
M
Margarida Barreto
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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