Clinical Trials Logo
  1. Home
  2. Friedreich's Ataxia
  3. NCT04102501

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

Friedreich's Ataxia Clinical Trial

Official title:
A Randomized, Double-Blind, Controlled, Phase 2/3 Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Friedreich's Ataxia

Clinical Trial Summary

The purpose of this study is to assess the Efficacy, Long Term Safety and Tolerability of RT001 in subjects with Friedreich's Ataxia

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, in subjects with FRDA following the oral administration of study drug (active or placebo capsules). Sixty eligible patients will undergo various assessments at different time points during the the study. The study duration is 13 months which includes screening, treatment and safety follow up phone call. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04102501
Study type Interventional
Source Retrotope, Inc.
Contact
Status Completed
Phase Phase 3
Start date October 30, 2019
Completion date August 23, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT02660112 - (+) Epicatechin to Treat Friedreich's Ataxia Phase 2
Recruiting NCT02497534 - Biomarkers in Friedreich's Ataxia
Completed NCT01962363 - EPI-743 in Friedreich's Ataxia Point Mutations Phase 2
Completed NCT02179333 - Preliminary Study of the Scale To Assess Ataxia and Neurologic Dysfunction (STAND)
Completed NCT01016366 - Safety Study of Carbamylated Erythropoietin to Treat Patients With the Neurodegenerative Disorder Friedreich's Ataxia Phase 2
Recruiting NCT02069509 - Patient Registry of the European Friedreich's Ataxia Consortium for Translational Studies (EFACTS)
Terminated NCT00803868 - Pilot Study of Varenicline (Chantix®) in the Treatment of Friedreich's Ataxia Phase 2/Phase 3
Completed NCT02797080 - Long-Term Safety Extension Study of ACTIMMUNE® (Interferon γ-1b) in Children and Young Adults With Friedreich's Ataxia Phase 3
Completed NCT02415127 - Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia Phase 3
Completed NCT00897221 - A Study Investigating the Long-term Safety and Efficacy of Deferiprone in Patients With Friedreich's Ataxia Phase 2
Completed NCT02840669 - A Study to Characterize the Cardiac Phenotype of Individuals With Friedreich's Ataxia (CARFA Study) N/A
Completed NCT00697073 - Study to Assess the Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients Phase 3
Recruiting NCT02316314 - Characterization of the Cardiac Phenotype of Friedreich's Ataxia (FRDA)
Completed NCT00631202 - Efficacy of Epoetin Alfa in Patients With Friedreich's Ataxia Phase 2
Completed NCT01728064 - Safety and Efficacy of EPI-743 in Patients With Friedreich's Ataxia Phase 2
Completed NCT02593773 - Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia Study Phase 3
Completed NCT01035671 - Safety and Efficacy Study of A0001 in Subjects With Friedreich's Ataxia Phase 2
Completed NCT00811681 - Effect of Pioglitazone Administered to Patients With Friedreich's Ataxia: Proof of Concept Phase 3
Completed NCT00537680 - Study to Assess the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Phase 3
Completed NCT02445794 - A First in Human Study of RT001 in Patients With Friedreich's Ataxia Phase 1/Phase 2