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Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis

NCT03267277 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-11-26

Study results available
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Summary

Background:

Dermatomyositis (DM) and juvenile dermatomyositis (JDM) cause inflammation in the muscles. People with DM and JDM can develop calcium deposits in places they should not, known as calcinosis. Calcinosis can be painful and cause disabilities and other problems. Researchers want to learn more about calcinosis to find treatments for it.

Objective:

To test if sodium thiosulfate (STS) can treat people with DM with calcinosis.

Eligibility:

People ages 7 and older who have moderate or severe calcinosis. They must have stable DM and calcium deposits in the torso or at least 2 limbs.

Design:

Participants will be screened with:

* Medical history
* Physical exam
* Muscle strength and function tests
* Blood and urine tests

Participants will have several visits:

* 7-day pre-treatment visit about 10 weeks before starting STS
* Treatment visits over 10 weeks. They will get STS 3 times a week through IV infusion. They may be hospitalized the whole time. If they tolerate the drug, they may be discharged at certain times. During these times, they will return for the infusions.
* 3- to 5-day post-treatment visits 24 weeks and 62 weeks after starting STS.

Visits may include repeats of screening tests and:

* Questionnaires
* Scans: They lie in a machine that takes pictures of the body. They may be injected with a radioactive agent.
* Durometry: A small instrument applies pressure on the skin or exposed calcinosis.
* Measurements of blood flow in the arms and fingernail blood vessels
* Photographs of the skin
* Kidney ultrasound
* Tests of kidney function
* Calcinosis aspiration: A needle placed into areas of calcinosis removes liquid.

Conditions

  • Dermatomyositis
  • Idiopathic Inflammatory Myopathies

Interventions

DRUG

Sodium Thiosulfate

Sodium thiosulfate is a calcium chelator

Sponsors & Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

    lead NIH

Principal Investigators

  • Adam I Schiffenbauer, M.D. · National Institute of Environmental Health Sciences (NIEHS)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-05
Primary Completion
2022-11-04
Completion
2023-11-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03267277 on ClinicalTrials.gov