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NCT02445794 · ClinicalTrials.gov registry record · Phase 1
A First in Human Study of RT001 in Patients With Friedreich's Ataxia
A Phase 1 study of Friedreich's Ataxia, sponsored by Biojiva.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 2
- Study locations
NCT02445794: Completed Phase 1 study of Friedreich's Ataxia, sponsored by Biojiva.
NCT02445794 is a Phase 1 study of Friedreich's Ataxia that has completed, run by Biojiva. The registered enrollment target is 19 participants, below the 77-participant average among 5 other Friedreich's Ataxia trials with a reported enrollment target (75% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02445794, a Phase 1 study of Friedreich's Ataxia, has completed, sponsored by Biojiva.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of RT001 in patients with Friedreich's ataxia.
Conditions Studied
Interventions
- DRUG Low dose cohort
- DRUG High dose cohort
Study Locations (2)
California
- Collaborative Neuroscience Network, LLC - Long Beach
Florida
- University of South Florida - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2015-08 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
What the finished NCT02445794 record still lists
NCT02445794 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 77-participant average among 5 other Friedreich's Ataxia trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Friedreich's Ataxia appearing as the primary indexed condition, and to 2 interventions - of which Low dose cohort is the first listed.
NCT02445794 reports a single indexed study location in California, Florida.
Frequently Asked Questions
What is clinical trial NCT02445794 about?
NCT02445794 is a clinical study titled "A First in Human Study of RT001 in Patients With Friedreich's Ataxia". The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of RT001 in patients with Friedreich's ataxia.
What is the current status of trial NCT02445794?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2015-08. Estimated completion is 2016-07.
What conditions does trial NCT02445794 study?
This clinical trial studies the following conditions: Friedreich's Ataxia.
What interventions are being tested in trial NCT02445794?
The interventions under investigation include: Low dose cohort (DRUG), High dose cohort (DRUG).
Who is sponsoring clinical trial NCT02445794?
This trial is sponsored by Biojiva, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02445794 being conducted?
This trial has 2 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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