Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT07093268
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 18 years or older.
* Participants are ambulatory with or without an assistive device.
* Sporadic or familial ALS diagnosis with possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria.
* Slow vital capacity (SVC) measure ≥70% of predicted for gender, height, and age.
* 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).
* Capable of reading and providing informed consent and following study procedures.
* Geographic accessibility to the study center and the ability to travel to the clinic for study visits by ground transportation.
* 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.
* 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.
* Patients may take other drugs approved for treatment of ALS at the dose prescribed by their neurologist.
Exclusion Criteria:
* Participants with bulbar-onset ALS
* 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:
1. Anatomical factors at or near the site of implantation;
2. Underlying disorders of the coagulation cascade or platelet function (eg, hemophilia, Von Willebrand's disease, liver disease);
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
4. Use of nutritional supplements (eg, St John's Wort) within 7 days before or after pump implantation.
* Presence of infection including but not limited to: meningitis, ventriculitis, skin infection, bacteremia, or septicemia.
* 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.
* Inability to have the infusion pump implanted ≤ 2.5 cm below the skin surface.
* Body weight and size unable to accept the infusion pump bulk and weight.
* Spinal anomalies which would complicate the implantation and fixation of the catheter for IP delivery.
* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) value \> 2.0 times the upper normal.
* A life expectancy of less than 6 months, based on the judgment of the investigator.
* Presence of tracheostomy.
* 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.
* History of active substance abuse within the prior year.
* At risk for committing suicide per investigator judgment.
* Clinically significant history of unstable or severe cardiac, oncologic, hepatic, or renal disease, or other medically significant illness.
* Pregnant women or women currently breastfeeding.
* Exposure to any investigational drug, device, or biologic within 30 days of screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07093268
Study Brief:
Protocol Section:
NCT07093268