NCT03449212Suspended
SOD1 Kinetics Measurements in ALS Patients
Source: ClinicalTrials.gov · Last updated 25 Jul 2024
Reason given: COVID-19 pandemic
Brief summary (registry, in English)
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.
- Status (registry)
- Suspended
- Study type
- Observational
- Enrollment
- 86 (estimated)
- First submitted
- 6 Feb 2018
- Start date
- Dec 2012
- Primary completion date
- Dec 2025
- Lead sponsor
- Washington University School of Medicine
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT03449212
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.
- Allergy to Lidocaine
Lab values
- Safety lab values greater than 2X the upper limit of normal
Other
- Invasive ventilator dependence, such as tracheostomy
- Any known or suspected abnormal CSF pressure or intracranial/intraspinal tumors.
- Clinical judgment of the Site Investigator that the subject would be unable to undergo multiple lumbar punctures.
- Pregnancy
- Any contraindication for lumbar puncture
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University in St. Louis | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.