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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 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 36 participants.
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.
Interventions
- DRUG Cysteamine Bitartrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2014-05 |
| Est. Completion | 2016-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02023866
The ClinicalTrials.gov registry entry for NCT02023866 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cysteamine Bitartrate is the first listed.
NCT02023866 reports 0 study locations.
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.
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