Acute Spinal Cord Injury (SCI)Phase 1/2eSpineNCT06677229
Phase 1b/2a Clinical Trial to Determine the Safety, Tolerability and Efficacy of TZ-161 in Spinal Cord Injury
A Phase 1/2 study testing Eletriptan HBr 40 mg in people with Acute Spinal Cord Injury (SCI), run by Technophage, SA at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Spinal Cord Injury (SCI)
- What is being tested?
- Eletriptan HBr 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Aug 2025to Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Uncontrolled hypertension.
- Recent use (i.e., within 24 hours) of serotonin receptor agonists
- Coadministration with SSRIs, SNRIs, TCAs, and MAO due to risk of serotonin syndrome.
- Recent use (i.e., within 24 hours) of drugs containing ergotamine or ergot-like substances (such as dihydroergotamine or methysergide)
- Hypersensitivity to IMP and its excipients (angioedema and anaphylaxis seen).
- The following medications and/or substances are not allowed due to potential interaction with Eletriptan HBr or inhibition of the CYP3A4 system (recent use, i.e., within at least 72 hours):
- Cimetidine; ketoconazole; itraconazole; fluconazole, erythromycin; clarithromycin, troleandomycin, verapamil, and MAO inhibitors [such as isocarboxazid (Marplan), phenelzine sulfate (Nardil), tranylcypromine (Parmate), selegiline (Emsam)], pioglitazone, and valerian.
- Antiretrovirals - such as ritonavir, indinavir, nelfinavir, efavirenz and nevirapine.
- Other prohibited concomitant medications include haloperidol, trazodone, triazolam, nefazodone, diltiazem, carbamazepine, phenytoin, oxcarbazepine, and phenobarbital.
- St. John's Wort (Hypericum perforatum).
- Subjects with known liver disease (except for Child Pugh A) or severe hepatic impairment.
- Subjects with known renal disease or severe renal impairment - exclude if eGFR below 50 ml/min.
- Subjects that have participated in any other study in the last 3 months or plan to participate in another study at any time during this clinical trial.
- Subjects that have foreign magnetic metal bodies or other conditions that render them unable to perform MRI.
- Any other issue that, in the opinion of the investigator, makes the subject unsuitable for study participation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Reina Sofia
Córdoba
Simon Fuentes, MD, +34 957 010 000, juc.hrs.sspa@juntadeandalucia.es
- Recruiting
Hospital Universitario La Paz
Madrid
Marisa Gandia, MD, +34917277000, fundacion.hulp@salud.madrid.org
About this study
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
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.
Read the 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)
- Being tested
- Eletriptan HBr 40 mg
- Keywords
- acute spinal cord injury, TZ-161, Eletriptan Hydrobromide, Eletriptan HBr, serotonin receptor, 5-HT receptor, Relert, Relpax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eletriptan HBr 40 mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm Randomized to IMP (Eletriptan HBr) + SOC | Experimental | Not described Receives: Drug: Eletriptan HBr 40 mg |
| Control Arm after SCI Randomized to SOC | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effects
Incidence of treatment-emergent AEs and treatment-emergent SAEs
Measured: Between Day 1 and Month 6 in IMP plus SOC compared to SOC alone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Spinal Cord Injury (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technophage, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VectorB2B
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677229
- Sponsor's protocol ID
- TZ-161-101
- Other IDs
- 2023-509207-33-01, 2023
- Acronym
- eSpine
- Status last verified
- Sep 2025
- First submitted
- 4 Nov 2024
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06677229
- Acronym / sponsor ID
- eSpine / TZ-161-101
- Conditions
- Acute Spinal Cord Injury (SCI)
- Keywords
- acute spinal cord injury, TZ-161, Eletriptan Hydrobromide, Eletriptan HBr, serotonin receptor, 5-HT receptor, Relert, Relpax
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Technophage, SAIndustry (pharma, biotech, devices)
- Collaborators
- VectorB2B
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm Randomized to IMP (Eletriptan HBr) + SOC | Experimental | Drug: Eletriptan HBr 40 mg |
| Control Arm after SCI Randomized to SOC | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects aged 18-65 years old.
- Subjects with clinical diagnosis of acute SCI that comply with the following:
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eletriptan HBr 40 mgOral 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. | Drug | Experimental Arm Randomized to IMP (Eletriptan HBr) + SOC |
Primary outcome
Adverse effects
Time frame: Between Day 1 and Month 6 in IMP plus SOC compared to SOC alone
Incidence of treatment-emergent AEs and treatment-emergent SAEs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Eletriptan HBr 40 mg in people with Acute Spinal Cord Injury (SCI), run by Technophage, SA at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofia Corte-Real (+351 215943993, scortereal@technophage.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse effects (time frame: Between Day 1 and Month 6 in IMP plus SOC compared to SOC alone). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.