Eletriptan HBr for Acute spinal cord injury | Spinal cord injury

Inclusion criteria

• {"criterion_text":"- Subjects aged 18-65 years old.\n- Subjects with clinical diagnosis of acute SCI that comply with the following: a. Injury located on the thoracic region (T1 to T12). b. With clinical suspicion of a single traumatic (contusion) lesion. c. 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. d. Ability to perform injury-to-drug administration ≤ 48 hours after SCI.\n- Subjects willing and able to provide an informed consent.\n- Subjects willing and able to complete the study and comply with instructions."}

Exclusion criteria

• {"criterion_text":"- Clinical or imaging suspicion of multi-lesion or extra-thoracic contusions on diagnostic CT scan and on MRI at 72H.\n- Subjects presenting any contraindications, special warnings, and precautions regarding IMP administration, as per described in the SmPC of Eletriptan HBr: a. Ischemic CAD, such as angina pectoris, history of myocardial infarction, and documented silent ischemia, or coronary artery vasospasm, including Prinzmetal’s angina. b. Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders. c. History of stroke, TIA, or history or current evidence of hemiplegic or basilar migraine because these patients are at a higher risk of stroke. d. Peripheral vascular disease. e. Ischemic bowel disease. f. Uncontrolled hypertension. g. Recent use (i.e. 48 hours) of serotonin receptor agonists h. Coadministration with SSRIs, SNRIs, TCAs, and MAO due to risk of serotonin syndrome. i. Recent use (i.e., within 48 hours) of drugs containing ergotamine or ergot-like substances (such as dihydroergotamine or methysergide) j. Hypersensitivity to IMP and its excipients (angioedema and anaphylaxis seen).\n- 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): a. 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. b. Antiretrovirals - such as ritonavir, indinavir, nelfinavir, efavirenz and nevirapine. c. Other prohibited concomitant medications include haloperidol, trazodone, triazolam, nefazodone, diltiazem, carbamazepine, phenytoin, oxcarbazepine, and phenobarbital. d. St. John's Wort (Hypericum perforatum).\n- Subjects with known liver disease (except for Child Pugh A) or severe hepatic impairment.\n- Subjects with known renal disease or severe renal impairment – exclude if eGFR below 50 ml/min.\n- 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.\n- Subjects that have foreign magnetic metal bodies or other conditions that render them unable to perform MRI.\n- Any other issue that, in the opinion of the investigator, makes the subject unsuitable for study participation.\n- Subjects in coma or with significant cognitive impairment in the opinion of the investigator.\n- Subjects presenting mechanical ventilation dependence.\n- 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.\n- Subjects with dysphagia or inability to swallow tablets.\n- Women who are breastfeeding or who are pregnant. Pregnancy to be excluded during screening by presence of a negative blood pregnancy test.\n- Subjects with active malignancy, or malignancy in the last 5 years taking prohibited medication.\n- Subjects that have recently used Eletriptan HBr (within the last 48h).\n- Subjects presenting clinically significant ECG abnormalities (Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders) at screening."}

Primary endpoints

• {"endpoint_text":"- Incidence of treatment-emergent AEs and treatment-emergent SAEs between D1 and M6 in IMP plus SOC compared to SOC alone.","definition_or_measurement_approach":"Measured as the incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) occurring between Day 1 and Month 6, comparing IMP+SOC versus SOC alone."}

Secondary endpoints

• {"endpoint_text":"- Absolute change in MAS and BPI from baseline to follow-up visits (M1, M3 and M6) in IMP plus SOC compared to SOC alone.","definition_or_measurement_approach":"Absolute change from baseline to Months 1, 3 and 6 in MAS (Modified Ashworth Scale) and BPI (Brief Pain Inventory) scores, comparing IMP+SOC versus SOC alone."}
• {"endpoint_text":"- Difference in length of stay observed in IMP plus SOC compared to SOC alone regarding: a. Time spent in the ICU [defined as time from ICU admission to discharge from ICU]. b. Time spent in the hospital [defined as time from hospital admission to discharge from hospital].","definition_or_measurement_approach":"Difference in time spent in ICU (time from ICU admission to ICU discharge) and time spent in hospital (time from hospital admission to hospital discharge) between IMP+SOC and SOC alone."}
• {"endpoint_text":"- Absolute change in ASIA Impairment Scale (AIS) – ISNCSCI standards – motor and sensory scores from baseline to follow-up visits (M1, M3 and M6) in IMP plus SOC compared to SOC alone.","definition_or_measurement_approach":"Absolute change from baseline to Months 1, 3 and 6 in ASIA Impairment Scale (AIS) motor and sensory scores using ISNCSCI standards, comparing IMP+SOC versus SOC alone."}

Portugal

Earliest CTIS Part Ii Submission Date

13-05-2024

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

721

Number Of Sites

1

Number Of Participants

28

Spain

Earliest CTIS Part Ii Submission Date

28-01-2025

Latest Decision Or Authorization Date

16-03-2026

Processing Time Days

412

Number Of Sites

2

Number Of Participants

14

Primary sponsor

Full Name

Technophage Investigacao E Desenvolvimento Em Biotecnologia S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Portugal

Contract research organisations

Name

Vector B2B Drug Developing Associacao Para Investigacao Em Biotecnologia

Responsibilities

CRO contact provided (email cro@vectorb2b.com, phone 00351210976863); sponsor duties codes: 1,10,11,12,13,5,6,8,9

Third parties

• {"country":"Portugal","full_name":"Vector B2B Drug Developing Associacao Para Investigacao Em Biotecnologia","duties_or_roles":"codes: 1,10,11,12,13,5,6,8,9","organisation_type":"Pharmaceutical company"}