Trial Profile
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
Status:
Discontinued
Phase of Trial:
Phase II
Latest Information Update: 06 Nov 2021
Price :
$35
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At a glance
- Drugs Mercaptamine bitartrate (Primary)
- Indications Mitochondrial disorders
- Focus Therapeutic Use
- Sponsors Horizon Therapeutics plc; Raptor Pharmaceutical Inc
- 13 Apr 2018 Status has been changed to discontinued.
- 11 Apr 2017 Status changed from active, no longer recruiting to completed.
- 16 Feb 2017 Time frame of primary endpoint has been changed from Baseline vs. Month 24 to Baseline, Every 3 months and Study Exit (up to 24 Months). and Age group also changed from 2-17years to 6-17years.