SOD1 Kinetics Measurements in ALS Patients (NCT03449212) | Clinical Trial Compass
SuspendedNot Applicable
SOD1 Kinetics Measurements in ALS Patients
Stopped: COVID-19 pandemic
United States86 participantsStarted 2012-12
Plain-language summary
Washington University in St. Louis is seeking participants with ALS for a study to determine the half-life of the protein SOD1 in the cerebral spinal fluid. Mutations in the SOD1 gene are known to cause some forms of familial ALS. Researchers are developing a treatment to reduce the level of SOD1 in familial ALS, but need to know more about how long SOD1 stays in the body ("half-life") to help determine if the new treatment is effective.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 p…
What they're measuring
1
The primary outcome measurement will be the determination of the SOD1 half-life in the CSF of each subject.