NCT04102501View on ClinicalTrials.gov

A Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Friedreich's Ataxia

PHASE3CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

October 30, 2019

Primary Completion Date

August 23, 2021

Study Completion Date

August 23, 2021

Conditions
Friedreich's Ataxia
Interventions
DRUG

RT001

RT001 is encapsulated 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester, which is a site specific (C11) di-deutero synthetic homologue of LA ethyl ester. Each capsule contains 960 mg of RT001.

DRUG

Placebo

The placebo product is composed of encapsulated USP safflower oil. The placebo capsules are identical in appearance and size to RT001.

Trial Locations (6)

19104

Children's Hospital of Philadelphia, Philadelphia

32608

University of Florida, Gainesville

33612

USF Ataxia Research Center, Tampa

52242

University of Iowa Stead Family Children's Hospital, Iowa City

90095

UCLA, Los Angeles

90806

Collaborative Neuroscience Network, LLC, Long Beach

All Listed Sponsors
lead

Biojiva LLC

INDUSTRY

NCT04102501 - A Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Friedreich's Ataxia | Biotech Hunter | Biotech Hunter