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NCT01898884 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacology Study of VP 20629 in Adults With Friedreich's Ataxia
A Phase 1 study of Friedreich's Ataxia, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
- 5
- Study locations
NCT01898884: Completed Phase 1 study of Friedreich's Ataxia, sponsored by Shire.
NCT01898884 is a Phase 1 study of Friedreich's Ataxia that has completed, run by Shire. The registered enrollment target is 46 participants, below the 71-participant average among 5 other Friedreich's Ataxia trials with a reported enrollment target (35% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01898884, a Phase 1 study of Friedreich's Ataxia, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
- 5
- Study locations
Study Summary
The objectives of the study are: * To evaluate the safety and tolerability of single and multiple oral doses of VP 20629 in subjects with Friedreich's ataxia (FA). \[Primary\] * To characterize the pharmacokinetics of VP 20629 by investigation of the plasma concentration-time profile following single and multiple oral doses in subjects with FA. \[Secondary\] * To investigate the pharmacodynamic effects of VP 20629 on plasma 8-isoprostane and malondialdehyde and urinary 8-hydroxydeoxyguanosine concentrations following multiple oral doses in subjects with FA. \[Exploratory\]
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAEs), defined
Conditions Studied
Interventions
- DRUG Placebo
- DRUG VP 20629
Study Locations (5)
California
- UCLA Medical Center - Los Angeles
Florida
- University of South Florida - Tampa
Georgia
- Emory University - Atlanta
Iowa
- University of Iowa Children's Hospital - Iowa City
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2013-08-13 |
| Est. Completion | 2015-06-18 |
| Phase | Phase 1 |
What the finished NCT01898884 record still lists
NCT01898884 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 71-participant average among 5 other Friedreich's Ataxia trials with a reported enrollment target (35% lower).
The record links to 1 condition, with Friedreich's Ataxia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01898884 lists 5 locations in 5 states (California, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT01898884 about?
NCT01898884 is a clinical study titled "Safety and Pharmacology Study of VP 20629 in Adults With Friedreich's Ataxia". The objectives of the study are: * To evaluate the safety and tolerability of single and multiple oral doses of VP 20629 in subjects with Friedreich's ataxia (FA). \[Primary\] * To characterize the pharmacokinetics of VP 20629 by investigation of the plasma concentration-time profile following sing...
What is the current status of trial NCT01898884?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2013-08-13. Estimated completion is 2015-06-18.
What conditions does trial NCT01898884 study?
This clinical trial studies the following conditions: Friedreich's Ataxia.
What interventions are being tested in trial NCT01898884?
The interventions under investigation include: Placebo (DRUG), VP 20629 (DRUG).
Who is sponsoring clinical trial NCT01898884?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01898884 being conducted?
This trial has 5 study locations across California, Florida, Georgia, Iowa, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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