[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600113":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":29,"locations":39,"responsibleParty":75,"collaborators":20,"id":77,"slug":20,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":20,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":20,"enrollmentInfo":85,"targetDuration":20,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":99,"whyStopped":20,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Brain Trust Bio","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm","EXPERIMENTAL","Intrathecal riluzole continuous infusion up to 0.2 mg \u002F hr.",[13],"Drug: Intrathecal Riluzole",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Intrathecal Riluzole","Intrathecal infusion of riluzole for 6 weeks followed by 6 months treatment with safety committee approval.",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"David Schultz, Dr","Flinders Medical Centre","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":28,"role":25},"Antony Winkel, Dr","Sunshine Coast University Hospital",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":20,"email":34},"Chen Benkler, PhD","CONTACT","+1 857 285 8300","chen.benkler@gmail.com",{"name":36,"role":32,"phone":37,"phoneExt":20,"email":38},"Tina Soulis, PhD","+61 429 300 705","tina.soulis@alithialifesciences.com",[40,57],{"facility":28,"status":20,"city":41,"state":42,"zip":43,"country":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Birtinya","Queensland","4575","Australia",{"type":46,"coordinates":47},"Point",[48,49],153.11913,-26.74322,{"lat":49,"lon":48},[52,54],{"name":27,"role":32,"phone":20,"phoneExt":20,"email":53},"antony.winkel@health.qld.gov.au",{"name":55,"role":32,"phone":20,"phoneExt":20,"email":56},"Helen Rodgers","helen.rodgers2@health.qld.gov.au",{"facility":24,"status":20,"city":58,"state":59,"zip":60,"country":44,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Bedford Park","South Australia","5042",{"type":46,"coordinates":62},[63,64],138.56815,-35.02204,{"lat":64,"lon":63},[67,71],{"name":68,"role":32,"phone":69,"phoneExt":20,"email":70},"David Shcults, Dr","+618 8204 4187","david.schultz@sa.gov.au",{"name":72,"role":32,"phone":73,"phoneExt":20,"email":74},"Karalyn Ernst","+618 8204 5172","Karalyn.Ernst@sa.gov.au",{"type":76,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100600113",false,"NCT07093268","Safety of Intrathecal Riluzole in Patients With Amyotrophic Lateral Sclerosis","A Phase 1 Study to Determine the Safety and Tolerability of Continuous Intrathecal Riluzole in Patients With Progressive Ambulatory Amyotrophic Lateral Sclerosis","Inclusion Criteria:\n\n* Men and women aged 18 years or older.\n* Participants are ambulatory with or without an assistive device.\n* Sporadic or familial ALS diagnosis with possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria.\n* Slow vital capacity (SVC) measure ≥70% of predicted for gender, height, and age.\n* Medically able to undergo implantation of the SynchroMed II Infusion Pump according to the judgment of the investigator, or the presence of a previously implanted IT pump (not to be used for concurrent IT infusion of another IT agent).\n* Capable of reading and providing informed consent and following study procedures.\n* Geographic accessibility to the study center and the ability to travel to the clinic for study visits by ground transportation.\n* Women must not be able to become pregnant (eg, post menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study and 3 months after study completion. Adequate contraception includes: abstinence, hormonal contraception (oral contraception, implanted contraception, injected contraception or other hormonal (patch or contraceptive ring, for example) contraception), intrauterine device in place for ≥3 months, barrier method in conjunction with spermicide, or another adequate method.\n* Taking and tolerating oral riluzole 50 mg twice a day for at least 30 days prior screening and willingness to continue oral riluzole throughout duration of the study.\n* Patients may take other drugs approved for treatment of ALS at the dose prescribed by their neurologist.\n\nExclusion Criteria:\n\n* Participants with bulbar-onset ALS\n* Participants at risk of increased bleeding or uncontrolled bleeding during the SynchroMed II Infusion Pump implantation or following explant. This includes but is not limited to:\n\n  1. Anatomical factors at or near the site of implantation;\n  2. Underlying disorders of the coagulation cascade or platelet function (eg, hemophilia, Von Willebrand's disease, liver disease);\n  3. Administration of antiplatelet or anticoagulant medication within 7 days before or after pump implantation (eg, aspirin, clopidogrel bisulfate, rivaroxaban, nonsteroidal anti-inflammatory agents \\[NSAIDs\\]), or\n  4. Use of nutritional supplements (eg, St John's Wort) within 7 days before or after pump implantation.\n* Presence of infection including but not limited to: meningitis, ventriculitis, skin infection, bacteremia, or septicemia.\n* Testing positive for HIV (anti-HIV antibody), HBV (HBV surface antigen) or HCV (anti-HCV antibody; HCV RNA if anti-HCV antibody is positive) at screening.\n* Inability to have the infusion pump implanted ≤ 2.5 cm below the skin surface.\n* Body weight and size unable to accept the infusion pump bulk and weight.\n* Spinal anomalies which would complicate the implantation and fixation of the catheter for IP delivery.\n* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) value \\> 2.0 times the upper normal.\n* A life expectancy of less than 6 months, based on the judgment of the investigator.\n* Presence of tracheostomy.\n* The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair the ability of the participant to provide informed consent, per investigator judgment.\n* History of active substance abuse within the prior year.\n* At risk for committing suicide per investigator judgment.\n* Clinically significant history of unstable or severe cardiac, oncologic, hepatic, or renal disease, or other medically significant illness.\n* Pregnant women or women currently breastfeeding.\n* Exposure to any investigational drug, device, or biologic within 30 days of screening.","ALL","18 Years",{"count":86,"type":87},10,"ESTIMATED","INTERVENTIONAL",[90],"PHASE1","The purpose of this study is to investigate the safety and tolerability of intrathecal riluzole in adults with amyotrophic lateral sclerosis.",[93,94],"Amyotrophic Lateral Sclerosis","Motor Neuron Disease",[96,97,98],"Neurodegenerative Diseases","Nervous System Diseases","Neuromuscular Diseases","NOT_YET_RECRUITING","2025-07-22",{"date":102,"type":103},"2025-07-30","ACTUAL",{"date":105,"type":87},"2025-08-15",{"date":107,"type":87},"2027-01-15",{"name":5,"class":6},2]