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Clinical trial

An Open-Label, Dose-Escalating Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of Cysteamine Bitartrate Delayed-release Capsules (RP103) for Treatment of Children With Inherited Mitochondrial Disease

NCT02023866 is registered in ClinicalTrials.gov with Amgen as lead sponsor.

NCT NCT02023866
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Registry record

As filed in ClinicalTrials.gov.

Title
An Open-Label, Dose-Escalating Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of Cysteamine Bitartrate Delayed-release Capsules (RP103) for Treatment of Children With Inherited Mitochondrial Disease
Lead sponsor
Amgen
Phase
Phase 2
Overall status
Completed
Start date
May 31, 2014
Completion date
October 31, 2016
Enrollment
36 (actual)
Sites
5

Conditions

As the registry lists them; a condition with its own page is linked.

inherited mitochondrial disease, including leigh syndrome