ClinicalTrials.gov record
Terminated Phase 2 Interventional Results available

A Long-term Extension of Study RP103-MITO-001 (NCT02023866) to Assess Cysteamine Bitartrate Delayed-release Capsules (RP103) in Children With Inherited Mitochondrial Disease

ClinicalTrials.gov ID: NCT02473445

Public ClinicalTrials.gov record NCT02473445. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 5, 2026, 11:53 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Long-Term Open-Label Extension Study of RP103-MITO-001 to Assess the Safety, Tolerability and Efficacy of Cysteamine Bitartrate Delayed-release Capsules (RP103) for Treatment of Children With Inherited Mitochondrial Disease

Study identification

NCT ID
NCT02473445
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
Amgen
Industry
Enrollment
22 participants

Conditions and interventions

Interventions

  • Cysteamine Bitartrate Drug

Drug

Eligibility (public fields only)

Age range
6 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 18, 2015
Primary completion
Mar 5, 2017
Completion
Mar 5, 2017
Last update posted
Dec 26, 2024

2015 – 2017

United States locations

U.S. sites
5
U.S. states
4
U.S. cities
5
Facility City State ZIP Site status
University of California at San Diego (UCSD) San Diego California 92093-0935
Stanford University School of Medicine Stanford California 94305
Akron Children's Hospital Akron Ohio 44308
Baylor College of Medicine Houston Texas 77030
University of Utah Salt Lake City Utah 84132

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02473445, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 26, 2024 · Synced May 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02473445 live on ClinicalTrials.gov.

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