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:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT03449212
Eligibility Criteria:
Inclusion Criteria (with exceptions for each group):
* Males or females of any race aged 18 or older
* Positive for SOD1 mutation (SOD1 ALS only)
* Diagnosed with Definite, Probable or Possible ALS in accordance with El Escorial criteria (ALS and SOD1 Positive ALS only)
* Able to hold position and breathe comfortably for the duration of the LP procedure as determined by the LP physician or Nurse Practitioner
* Subjects must be able to provide informed consent
Exclusion Criteria for all groups:
* Invasive ventilator dependence, such as tracheostomy
* Medically unable to undergo lumbar puncture (LP) as determined by the investigator (i.e.,bleeding disorder, allergy to local anesthetics, a skin infection at or near the LP site, or evidence of high intracranial pressure).
* Any active dermatologic disease.
* Any connective tissue disease including systemic lupus erythematous, Sjögren's syndrome, scleroderma or mixed connective tissue disease.
* Any known or suspected abnormal CSF pressure or intracranial/intraspinal tumors.
* Use of anticoagulant medication (eg. warfarin, dalteparin, enoxaparin, rivaroxaban, fondaparinux, dabigatran) that cannot be safely withheld until coagulation parameters have normalized prior to lumbar puncture and for up to a week following the lumbar puncture.
* Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.
* Clinical judgment of the Site Investigator that the subject would be unable to undergo multiple lumbar punctures.
* Safety lab values greater than 2X the upper limit of normal
* Allergy to Lidocaine
* Pregnancy
* Any contraindication for lumbar puncture
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03449212
Study Brief:
Protocol Section:
NCT03449212