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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 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.

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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

FieldValue
Enrollment Target 19 participants
Start Date 2015-08
Est. Completion 2016-07
Phase Phase 1

Sponsor

Biojiva

4 total trials

What the Registry Record Tells You About NCT02445794

The ClinicalTrials.gov registry entry for NCT02445794 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 77-participant average among 5 other Friedreich's Ataxia trials with a reported enrollment target (75% lower). The listed sponsor is Biojiva, which has 4 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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