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Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study

NCT03707795 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-02-11

No results posted yet for this 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.

Conditions

  • Familial Amyotrophic Lateral Sclerosis

Interventions

DRUG

Betamethasone sodium phosphate/betamethasone acetate (Celestone® Soluspan®), 30 mg IM once a day for four days

Participants will be given four IM injections throughout the study

Sponsors & Collaborators

  • Edward Kasaraskis

    lead OTHER

Principal Investigators

  • Edward Kasarskis, MD · University of Kentucky

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2019-01-10
Completion
2019-01-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03707795 on ClinicalTrials.gov