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NCT02023866 · ClinicalTrials.gov registry record · Phase 2
Open-Label, Dose-Escalating Study Assessing Safety, Tolerability, Efficacy, of RP103 in Mitochondrial Disease
A Phase 2 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT02023866: Completed Phase 2 study, sponsored by Amgen.
NCT02023866 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02023866, a Phase 2 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
To evaluate safety, tolerability and efficacy of cysteamine bitartrate delayed-release capsules (RP103) administered at a target maintenance dose of 1.3 g/m²/day in two divided doses, every 12 hours, for up to 6 months in patients with inherited mitochondrial disease.
Primary Outcome
The NPMDS evaluates the progression of mitochondrial disease in pediatric patients in 4 domains: I - Current Function (vision, hearing, communication, feeding, and mobility) with scores ranging from 0 to 21; II -System Specific Involvement (seizures, encephalopathy, bleeding diathesis or coagulation defects, gastrointestinal, endocrine, respiratory, cardiovascular, renal, liver, and blood) with scores ranging from 0 to 30. III - Current Clinical Assessment (growth and development over past 6 m
Interventions
- DRUG Cysteamine Bitartrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2014-05 |
| Est. Completion | 2016-10 |
| Phase | Phase 2 |
What the finished NCT02023866 record still lists
NCT02023866 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Cysteamine Bitartrate is the first listed.
NCT02023866 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02023866 about?
NCT02023866 is a clinical study titled "Open-Label, Dose-Escalating Study Assessing Safety, Tolerability, Efficacy, of RP103 in Mitochondrial Disease". To evaluate safety, tolerability and efficacy of cysteamine bitartrate delayed-release capsules (RP103) administered at a target maintenance dose of 1.3 g/m²/day in two divided doses, every 12 hours, for up to 6 months in patients with inherited mitochondrial disease.
What is the current status of trial NCT02023866?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2014-05. Estimated completion is 2016-10.
What interventions are being tested in trial NCT02023866?
The interventions under investigation include: Cysteamine Bitartrate (DRUG).
Who is sponsoring clinical trial NCT02023866?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02023866's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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