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:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT02870634
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent prior to initiation of any study-specific procedures;
* Familial or sporadic ALS/MND defined as clinically possible, probable, or definite by Awaji-shima Consensus Recommendations;
* First ALS/MND symptoms occurred no more than 2 years prior to screening visit;
* Seated FVC ≥ 70% and SNP ≥ 50% of predicted value;
* Not taking riluzole or on a stable dose of riluzole for at least 4 weeks prior to screening visit (participants are not allowed to start taking riluzole during the study);
* Age between 18 and 75 years at time of informed consent;
* Patient has a competent caregiver who can and will be responsible for administration of study drug;
* Adequate bone marrow reserve, renal and liver function:
* absolute neutrophil count ≥ 1500/µL
* lymphocyte count \< 48%
* platelet count ≥ 150,000/µL
* hemoglobin ≥ 11 g/dL
* creatinine clearance ≥ 60 mL/min (Cockroft \& Gault formula)
* ALT and/or AST ≤ 2 x ULN
* total bilirubin ≤ 1.5 x ULN
* serum albumin ≥ 2.8 g/dL
* Women and men with partners of childbearing potential must take effective contraception while on study and women of childbearing potential must have a negative pregnancy test and be non-lactating at screening
Exclusion Criteria:
* Inability to swallow oral medications or presence of GI disorder deemed to jeopardize intestinal absorption of Cu(II)ATSM
* Dependence of mechanical ventilation (non-invasive or invasive) for any part of day or night
* Exposure to any other investigational agent within 3 months or two investigational agents within 6 months prior to screening visit
* Active GI disease (except gastrointestingal reflux disease) within 30 days of screening visit
* Known immune compromising illness or treatment
* Presence of any of the following clinical conditions
* drug abuse or alcoholism
* unstable cardiac, pulmonary, renal, hepatic, endocrine or hematologic disorder
* active infectious disease
* AIDS or AIDS-related complex
* current malignancy
* unstable psychiatric illness, defined as psychosis or untreated major depression within 90 days of screening visit
* neuromuscular disease other than ALS/MND
* Dementia that may affect either outcome measures or patient understanding and/or compliance with study requirements and procedures
* Use of anticoagulants at therapeutic doses within 7 days prior to screening visit
* Current use of strong inducers or inhibitors of CYPs 2C19 and 2D6
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02870634
Study Brief:
Protocol Section:
NCT02870634