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NCT03707795 · ClinicalTrials.gov registry record · Early Phase 1
Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study
A Early Phase 1 study, sponsored by Edward Kasaraskis.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
NCT03707795: Completed Early Phase 1 study, sponsored by Edward Kasaraskis.
NCT03707795 is a Early Phase 1 study that has completed, run by Edward Kasaraskis. The registered enrollment target is 6 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03707795, a Early Phase 1 study, has completed, sponsored by Edward Kasaraskis.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
By doing this study the investigator hopes to learn more about a potential cause of amyotrophic lateral sclerosis (ALS) called "oxidative stress". Oxidative stress is essentially an imbalance between the production of certain chemicals in the body called "free radicals" and the ability of the body to counteract or detoxify their harmful effects through neutralization by antioxidants. It is thought that factors such as environmental exposure (chemicals and lead), diet, smoking,alcohol consumption, physical activity and psychological stress cause oxidative stress to occur inside the body. By doing this study, the investigator hopes to learn whether the FDA-approved steroid medication called Betamethasone will restore overall antioxidant activity fALS patients with mutations in the Fused in Sarcoma gene (FUS gene). Participants who agree to take part in this research study, agree to the following responsibilities: * Attend all scheduled visits * Notify the study doctor of any illnesses, unexpected or troublesome side effects, or any other medical problems that occur during the study * Be completely honest with their answers to all questions * Check with the study doctor before taking any new medications, whether prescribed or "over the counter," even vitamins and herbal supplements.
Primary Outcome
Blood will be collected at multiple time points (baseline, 24 hours, 48 hours, 72 hours, day 7 and day 14) for analysis of Betamethasone levels. Data will be reported as the change in Betamethasone over time.
Interventions
- DRUG Betamethasone sodium phosphate/betamethasone acetate (Celestone® Soluspan®), 30 mg IM once a day for four days
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2017-08-21 |
| Est. Completion | 2019-01-10 |
| Phase | Early Phase 1 |
What the finished NCT03707795 record still lists
NCT03707795 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Betamethasone sodium phosphate/betamethasone acetate (Celestone® Soluspan®), 30 mg IM once a day for four days is the first listed.
NCT03707795 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03707795 about?
NCT03707795 is a clinical study titled "Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study". By doing this study the investigator hopes to learn more about a potential cause of amyotrophic lateral sclerosis (ALS) called "oxidative stress". Oxidative stress is essentially an imbalance between the production of certain chemicals in the body called "free radicals" and the ability of the body t...
What is the current status of trial NCT03707795?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2017-08-21. Estimated completion is 2019-01-10.
What interventions are being tested in trial NCT03707795?
The interventions under investigation include: Betamethasone sodium phosphate/betamethasone acetate (Celestone® Soluspan®), 30 mg IM once a day for four days (DRUG).
Who is sponsoring clinical trial NCT03707795?
This trial is sponsored by Edward Kasaraskis, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03707795's enrollment target sits among peer trials
6 1846th of 2000 higher than 114 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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