Status:
SUSPENDED
SOD1 Kinetics Measurements in ALS Patients
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Amyotrophic Lateral Sclerosis, Familial
Amyotrophic Lateral Sclerosis, Sporadic
Eligibility:
All Genders
18+ years
Brief 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 cau...
Detailed Description
Background: Novel targeted therapeutic strategies are being developed for genetic subsets of ALS, such as those caused by dominantly inherited mutations in the superoxide dismutase 1 gene (SOD1). Inve...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT03449212
Start Date
December 1 2012
End Date
December 1 2026
Last Update
July 25 2024
Active Locations (1)
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1
Washington University in St. Louis
St Louis, Missouri, United States, 63110