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Friedreich's Ataxia clinical trials

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NCT ID: NCT04102501 Completed - Friedreich's Ataxia Clinical Trials

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

Start date: October 30, 2019
Phase: Phase 3
Study type: Interventional

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

NCT ID: NCT02840669 Completed - Friedreich's Ataxia Clinical Trials

A Study to Characterize the Cardiac Phenotype of Individuals With Friedreich's Ataxia (CARFA Study)

Start date: July 2016
Phase: N/A
Study type: Interventional

Friedreich's ataxia (FA) is an autosomal recessive disease with an incidence of 1/50,000 in the Caucasian population. The main manifestations of FA are progressive sensory and cerebellar ataxia and cardiomyopathy (CM). It is the most common form of inherited ataxia. A severe CM affects ~60% of FA patients, mostly young adults, and leads to cardiac failure then death. Currently, no therapy can change the course of this severe cardiomyopathy. This study is designed to characterize the cardiac manifestations of FA using cardiac magnetic resonance (CMR), echocardiography, serum cardiac biomarkers and evaluation of fatigue severity, in the context of the neurological disease.

NCT ID: NCT02797080 Completed - Friedreich's Ataxia Clinical Trials

Long-Term Safety Extension Study of ACTIMMUNE® (Interferon γ-1b) in Children and Young Adults With Friedreich's Ataxia

STEADFAST
Start date: June 28, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this long term extension study is to evaluate the long-term safety of ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia (FA).

NCT ID: NCT02660112 Completed - Friedreich's Ataxia Clinical Trials

(+) Epicatechin to Treat Friedreich's Ataxia

Start date: September 2016
Phase: Phase 2
Study type: Interventional

This 24-week study will test the safety and effectiveness of synthetically produced (+) Epicatechin in treating patients who have Friedreich's Ataxia, a neurological disorder.

NCT ID: NCT02593773 Completed - Friedreich's Ataxia Clinical Trials

Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia Study

STEADFAST
Start date: December 25, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this phase 3 multi-center, open-label extension study is to evaluate the long-term safety of ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia.

NCT ID: NCT02445794 Completed - Friedreich's Ataxia Clinical Trials

A First in Human Study of RT001 in Patients With Friedreich's Ataxia

Start date: August 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of RT001 in patients with Friedreich's ataxia.

NCT ID: NCT02415127 Completed - Friedreich's Ataxia Clinical Trials

Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia

STEADFAST
Start date: June 2015
Phase: Phase 3
Study type: Interventional

The purpose of this phase 3 randomized, multi-center, double-blind, placebo-controlled study is to evaluate the efficacy and safety of ACTIMMUNE® (interferon-γ 1b) in the treatment of Friedreich's Ataxia (FA) and to evaluate the pharmacokinetic (PK) characteristics of ACTIMMUNE® in FA patients.

NCT ID: NCT02179333 Completed - Friedreich's Ataxia Clinical Trials

Preliminary Study of the Scale To Assess Ataxia and Neurologic Dysfunction (STAND)

STAND
Start date: October 2012
Phase:
Study type: Observational

The objectives of this study are: - To validate the inter-rater and intra-rater reliability of a new scale for the assessment of ataxia and neurologic dysfunction (STAND) - To assess common constructs and correlation between STAND subscale items.

NCT ID: NCT01962363 Completed - Friedreich's Ataxia Clinical Trials

EPI-743 in Friedreich's Ataxia Point Mutations

Start date: October 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effects of EPI-743 in patients with Friedreich's Ataxia point mutations

NCT ID: NCT01898884 Completed - Friedreich's Ataxia Clinical Trials

Safety and Pharmacology Study of VP 20629 in Adults With Friedreich's Ataxia

Start date: August 13, 2013
Phase: Phase 1
Study type: Interventional

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]