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Tests treatment safety and results for Acute Spinal Cord Injury (SCI)
Official title Phase 1b/2a Clinical Trial to Determine the Safety, Tolerability and Efficacy of TZ-161 in Spinal Cord Injury
ClinicalTrials.gov ID: NCT06677229
What this study is testing
What is Eletriptan HBr 40 mg?
Eletriptan HBr 40 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for acute spinal cord injury (sci).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- people aged 18-65 years old.
- people 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.
You likely can't join if
- Clinical or imaging suspicion of multi-lesion or extra-thoracic contusions on diagnostic CT scan and on MRI at 48H\ .
- people in coma or with significant cognitive impairment in the opinion of the investigator.
- people presenting mechanical ventilation dependence.
- people with past medical history of any - structural - neurological disorder of the central or peripheral nervous system, including past spinal cord...
- people 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.
See the full eligibility criteria
- people aged 18-65 years old.
- people 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.
- people willing and able to provide an informed consent.
- people 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 how well it works of Eletriptan HBr in patients over...
- Clinical or imaging suspicion of multi-lesion or extra-thoracic contusions on diagnostic CT scan and on MRI at 48H\ .
- people in coma or with significant cognitive impairment in the opinion of the investigator.
- people presenting mechanical ventilation dependence.
- people with past medical history of any - structural - neurological disorder of the central or peripheral nervous system, including past spinal cord injury. Furthermore, people with spine/bone-related medical history...
- people 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.
- people with active malignancy, or malignancy in the last 5 years if subject is currently undergoing treatment with prohibited medication.
- people that have recently used Eletriptan HBr (within the last 24h).
- people presenting clinically significant ECG abnormalities (Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders) at screening.
- people 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)...
- 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).
- people with known liver disease (except for Child Pugh A) or severe hepatic impairment.
- people with known renal disease or severe renal impairment - exclude if eGFR below 50 ml/min.
- people 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.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Córdoba, Spain
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Córdoba, Spain; Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.