[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Brain Trust Bio\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100600113","phase-1-safety-of-intrathecal-riluzole-in-patients-with-amyotrophic-lateral-sclerosis-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":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this study is to investigate the safety and tolerability of intrathecal riluzole in adults with amyotrophic lateral sclerosis.",[26,27],"Amyotrophic Lateral Sclerosis","Motor Neuron Disease",[29,30,31],"Neurodegenerative Diseases","Nervous System Diseases","Neuromuscular Diseases","NOT_YET_RECRUITING","2025-07-22",{"date":35,"type":36},"2025-07-30","ACTUAL",{"date":38,"type":20},"2025-08-15",{"date":40,"type":20},"2027-01-15",{"name":42,"class":43},"Brain Trust Bio","INDUSTRY",2,""]