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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03707795 |
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Date of registration:
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14/09/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study
TRANSLATE |
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Scientific title:
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Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study |
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Date of first enrolment:
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August 21, 2017 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03707795 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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Early Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Edward Kasarskis, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Kentucky |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of familial ALS (fALS)
- Relative of a fALS person and carry the FUS gene
Exclusion Criteria:
- Under 20 years or over 80 years of age
- Cannot tolerate steroids, including betamethasone
- Are unwilling or unable to attend all scheduled research visits
- Currently participating in another clinical drug trial
- Major neurological disease, other than ALS
- Pregnant
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Familial Amyotrophic Lateral Sclerosis
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Intervention(s)
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Drug: Betamethasone sodium phosphate/betamethasone acetate (Celestone® Soluspan®), 30 mg IM once a day for four days
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Primary Outcome(s)
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Betamethasone plasma levels
[Time Frame: 14 days]
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Secondary Outcome(s)
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Superoxide dismutase plasma levels
[Time Frame: 14 days]
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Glutathione plasma levels
[Time Frame: 14 days]
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Peroxide plasma levels
[Time Frame: 14 days]
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Protein carbonyl plasma levels
[Time Frame: 14 days]
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Glutathione disulfide plasma levels
[Time Frame: 14 days]
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Secondary ID(s)
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17-0159-F6A
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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