[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659201":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":11,"studyPopulation":11,"armGroups":46,"interventions":57,"overallOfficials":11,"centralContacts":69,"locations":11,"responsibleParty":75,"collaborators":11,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":11,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":100,"whyStopped":11,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":11},{"fullName":5,"class":6},"Pharmazz, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients achieving a favorable functional outcome (GOS-E score ≥7) at Day 90 post-randomization.",null,"90 days",[14,17,20,22,24,26,28,30,32],{"measure":15,"description":11,"timeFrame":16},"Proportion of patients achieving a favorable functional outcome (GOS-E score ≥7) at Day 180 post-randomization.","180 days",{"measure":18,"description":11,"timeFrame":19},"Proportion of patients achieving a favorable functional outcome (GOS-E score ≥7) at Days 30 post-randomization.","30 days",{"measure":21,"description":11,"timeFrame":16},"Proportion of patients with an improvement in Disability Rating Scale (DRS) to less than or equal to 3 at Days 30, 90, and 180 post randomization.",{"measure":23,"description":11,"timeFrame":16},"Change in the Montreal Cognitive Assessment (MoCA) at Days 30, 90, and 180 post-randomization.",{"measure":25,"description":11,"timeFrame":16},"Change in the quality-of-life outcomes using Short Form (36) Health Survey (SF-36) at Days 30, 60, 90, 135, and 180 post-randomization.",{"measure":27,"description":11,"timeFrame":12},"Hospital free days from randomization to Day 90.",{"measure":29,"description":11,"timeFrame":12},"ICU free days from randomization to Day 90.",{"measure":31,"description":11,"timeFrame":16},"Incidence of all-cause mortality from randomization to Day 180.",{"measure":33,"description":11,"timeFrame":16},"Proportion of patients with adverse events (AEs) and serious adverse events (SAEs).",{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":11,"timePerspective":11,"maskingInfo":39},"RANDOMIZED","PARALLEL","This is a prospective, multicenter, randomized, double-blind, placebo-controlled, Phase III clinical study to assess the efficacy and safety of sovateltide in patients with traumatic brain injury. A total of 214 patients (107 patients in each treatment arm) with traumatic brain injury will be enrolled in this study.","TREATMENT",{"masking":40,"maskingDescription":11,"whoMasked":41},"QUADRUPLE",[42,43,44,45],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[47,52],{"label":48,"type":49,"description":11,"interventionNames":50},"The reference product is a matching placebo for sovateltide","PLACEBO_COMPARATOR",[51],"Drug: Placebo",{"label":53,"type":54,"description":11,"interventionNames":55},"The test product is sovateltide","ACTIVE_COMPARATOR",[56],"Drug: Sovateltide",[58,63],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":11},"DRUG","Placebo","The reference product is a matching placebo for sovateltide. It is a sterile lyophilized injection consisting of excipients formulated without the active ingredient in a 5.0 mL vial, to be reconstituted in 5 mL of normal saline (0.9% Sodium Chloride Injection).",[48],{"type":59,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"Sovateltide","The test product is sovateltide. It is available as a lyophilized injection containing 30 μg of sovateltide in a 5.0 mL vial, to be reconstituted in 5 mL normal saline (0.9% Sodium Chloride Injection).",[53],[68],"IRL-1620",[70],{"name":71,"role":72,"phone":73,"phoneExt":11,"email":74},"Anil Gulati","CONTACT","6307806087","anil.gulati@pharmazz.com",{"type":76,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659201","phase-3-phase-3-evaluation-of-sovateltide-for-the-treatment-of-acute-traumatic-brain-injury-100659201",false,"NCT07861126","Phase 3 Evaluation of Sovateltide for the Treatment of Acute Traumatic Brain Injury","A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Assess the Efficacy and Safety of Sovateltide in Patients With Traumatic Brain Injury","RESTORE-TBI","Inclusion Criteria:\n\nA participant will be eligible for inclusion in the study if the participant fulfills the following criteria:\n\n1. Adult male or female aged 18-90 years\n2. Consent must be obtained prior to any study-specific procedure from the participant or, if the participant lacks capacity to provide informed consent, from the participant's Legally Authorized Representative (LAR), in accordance with applicable law and IRB requirements.\n3. Clinical diagnosis of closed traumatic brain injury (TBI), classified as moderate to severe, with a post-resuscitation Glasgow Coma Scale (GCS) score of 5 to 13, inclusive, at screening (moderate TBI: GCS 9-13; eligible severe TBI range: GCS 5-8).\n4. Radiological confirmation of TBI on neuroimaging (diffuse injury II-V, Marshall's CT Classification).\n5. At least one reactive pupil (pinpoint pupils due to opioid pain treatment are considered reactive).\n6. The participant is \\\u003C48 hours from the time of TBI onset when the first dose of sovateltide is administered. The time of TBI onset is when the injury occurred.\n7. Reasonable expectation of availability to receive the full sovateltide course of therapy and to be available for subsequent follow-up visits.\n\nExclusion Criteria:\n\nA participant will not be considered eligible for inclusion in this study if the participant meets any of the following exclusion criteria:\n\n1. TBI caused by penetrating injury (e.g., gunshot wound) rather than blunt trauma.\n2. Isolated epidural hematoma.\n3. Suspected or confirmed spinal cord injury.\n4. Severe cardiac or hemodynamic instability prior to randomization.\n5. Life expectancy of less than 72 hours as determined by the Investigator.\n6. Pregnant or lactating women.\n7. Known medical history of neurological (other than current TBI) or psychiatric condition that, in the investigator's opinion, would confound the neurological and functional evaluations, lead to further deterioration of neurological status, or interfere with participation in this study.\n8. Evidence of any other major life-threatening or serious medical condition, such as severe renal, hepatic, and cardiovascular disease, which would prevent completion of the study protocol, impair the assessment of outcome, or in which sovateltide therapy would be contraindicated or might cause harm to the participant.\n9. Concurrent participation in any other therapeutic clinical trial.","ALL","18 Years","90 Years",{"count":89,"type":90},214,"ESTIMATED","INTERVENTIONAL",[93],"PHASE3","The study has been designed to advance sovateltide (IRL-1620) into a pivotal Phase III clinical trial for acute traumatic brain injury (TBI). With millions affected annually and zero approved neuroprotective pharmacotherapies available, this milestone marks a critical step forward in addressing one of modern medicine's greatest unmet needs. By harnessing our proprietary neural repair discovery platform, sovateltide targets the cascade of secondary cell death while stimulating neurogenesis and angiogenesis. Building on the strong momentum of our ongoing global Phase III RESPECT-ETB study in acute ischemic stroke, this study will further validate the broad therapeutic potential of our endothelin-B receptor platform across severe acute neurovascular conditions.",[96],"Traumatic Brain Injury",[96,98,99],"TBI (Traumatic Brain Injury)","Brain Injuries, Traumatic","NOT_YET_RECRUITING","2026-09-30",{"date":103,"type":104},"2026-10-06","ACTUAL",{"date":106,"type":90},"2026-12",{"date":108,"type":90},"2028-03",{"name":5,"class":6}]