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

> **NCT02473445** · PHASE2 · TERMINATED · sponsor: **Amgen** · enrollment: 22 (actual)

## Conditions studied

- Mitochondrial Diseases

## Interventions

- **DRUG:** Cysteamine Bitartrate

## Key facts

- **NCT ID:** NCT02473445
- **Lead sponsor:** Amgen
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2015-05-19
- **Primary completion:** 2017-03-06
- **Final completion:** 2017-03-06
- **Target enrollment:** 22 (ACTUAL)
- **Why stopped:** Sponsor decision to end development of RP103 for mitochondrial disease due to lack of efficacy demonstrated in base study RP103-MITO-001.
- **Last updated:** 2024-12-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02473445

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02473445, "A Long-term Extension of Study RP103-MITO-001 (NCT02023866) to Assess Cysteamine Bitartrate Delayed-release Capsules (RP103) in Children With Inherited Mitochondrial Disease". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT02473445. Licensed CC0.

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