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NCT03098797 · ClinicalTrials.gov registry record · Phase 2

A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome

A Phase 2 study of Barth Syndrome, sponsored by Stealth BioTherapeutics.

Completed
Registry status
Phase 2
Development phase
12
Enrollment target
1
Study location

NCT03098797 is a Phase 2 study of Barth Syndrome that has completed, run by Stealth BioTherapeutics. The registered enrollment target is 12 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT03098797, a Phase 2 study of Barth Syndrome, has completed, sponsored by Stealth BioTherapeutics.

COMPLETED
Registry status
Phase 2
Development phase
12 participants
Enrollment target
1
Study location

Study Summary

A randomized, double-blind cross over trial to evaluate the safety, efficacy, and tolerability of elamipretide in subjects with Barth syndrome.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Elamipretide

Study Locations (1)

Maryland

  • McKusick-Nathans Institute of Genetic Medicine, Johns Hopkins University School of Medicine - Baltimore

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2017-07-05
Est. Completion 2021-10-11
Phase Phase 2

Sponsor

Stealth BioTherapeutics

23 total trials

What the Registry Record Tells You About NCT03098797

The ClinicalTrials.gov registry entry for NCT03098797 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stealth BioTherapeutics, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Barth Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03098797 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT03098797 about?

NCT03098797 is a clinical study titled "A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome". A randomized, double-blind cross over trial to evaluate the safety, efficacy, and tolerability of elamipretide in subjects with Barth syndrome.

What is the current status of trial NCT03098797?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2017-07-05. Estimated completion is 2021-10-11.

What conditions does trial NCT03098797 study?

This clinical trial studies the following conditions: Barth Syndrome.

What interventions are being tested in trial NCT03098797?

The interventions under investigation include: Placebo (DRUG), Elamipretide (DRUG).

Who is sponsoring clinical trial NCT03098797?

This trial is sponsored by Stealth BioTherapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03098797 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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