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

NCT06677229 | Recruiting Phase 1 DMC

• 2 other identifiers: TZ-161-1012023-509207-33-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Acute Spinal Cord Injury (SCI)

Keywords

acute spinal cord injury; TZ-161; Eletriptan Hydrobromide; Eletriptan HBr; serotonin receptor; 5-HT receptor; Relert; Relpax

Outcome Measures

Primary Outcomes (1)

• Adverse effects

  Incidence of treatment-emergent AEs and treatment-emergent SAEs

  Between Day 1 and Month 6 in IMP plus SOC compared to SOC alone

Study Arms (2)

Experimental Arm Randomized to IMP (Eletriptan HBr) + SOC

EXPERIMENTAL

Drug: Eletriptan HBr 40 mg

Control Arm after SCI Randomized to SOC

NO INTERVENTION

Interventions

Eletriptan HBr 40 mg DRUG

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.

Experimental Arm Randomized to IMP (Eletriptan HBr) + SOC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects with dysphagia or inability to swallow tablets.
• Women who are breastfeeding or who are pregnant. Pregnancy to be excluded during screening by presence of a negative blood pregnancy test.
• Subjects with active malignancy, or malignancy in the last 5 years if subject is currently undergoing treatment with prohibited medication.
• Subjects that have recently used Eletriptan HBr (within the last 24h).
• Subjects presenting clinically significant ECG abnormalities (Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders) at screening.
• Subjects presenting any contraindications, special warnings, and precautions regarding IMP administration, as per described in the SmPC of Eletriptan HBr:
• Ischemic CAD, such as angina pectoris, history of myocardial infarction, and documented silent ischemia, or coronary artery vasospasm, including Prinzmetal's angina.
• Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders.
• History of stroke, TIA, or history or current evidence of hemiplegic or basilar migraine because these patients are at a higher risk of stroke.
• Peripheral vascular disease.
• Ischemic bowel disease.

Sponsors & Collaborators

• Technophage, SA: lead
• VectorB2B: collaborator

Study Sites (2)

Hospital Universitario Reina Sofia

Córdoba, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Spain

RECRUITING

MeSH Terms

Interventions

eletriptan

Central Study Contacts

Sofia Corte-Real

CONTACT

+351 215943993; scortereal@technophage.pt

Margarida Barreto

CONTACT

+351 215943993; mbarreto@technophage.pt

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Although this clinical trial is an open label study for both study subjects and site personnel, in order to minimise bias, the study will employ the use of blinded raters for performing the following efficacy-related endpoints/tests, hence the denomination of single-blinded study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)