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Friedreich Ataxia clinical trials

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NCT ID: NCT00993967 Completed - Freidreich's Ataxia Clinical Trials

Long-Term Safety and Tolerability of Idebenone in Friedreich's Ataxia Patients (MICONOS Extension)

Start date: June 2007
Phase: Phase 3
Study type: Interventional

This is an Extension study of the MICONOS main randomised placebo-controlled trial (NCT00905268), and open to those patients completing the main study. The scientific aim of this extension study is to monitor safety and tolerability of idebenone over two years in patients with Friedreich's Ataxia.

NCT ID: NCT00905268 Completed - Friedreich's Ataxia Clinical Trials

A Study of Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia (FRDA) Patients

MICONOS
Start date: April 2006
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to study the efficacy, safety and tolerability of idebenone in 12 months of treatment in children and adults with Friedreich's Ataxia. This is a randomised placebo-controlled double-blind trial conducted in Europe. Efficacy outcomes include measures of neurological impairment and function, and measures of the heart.

NCT ID: NCT00897221 Completed - Friedreich's Ataxia Clinical Trials

A Study Investigating the Long-term Safety and Efficacy of Deferiprone in Patients With Friedreich's Ataxia

Start date: June 2009
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of deferiprone in subjects with Friedreich's ataxia (FRDA). The secondary objective is to evaluate the long-term efficacy of deferiprone for the treatment of FRDA. The tertiary objectives are to evaluate the effect of deferiprone on: 1. cardiac function, 2. quality of life, and 3. functional status.

NCT ID: NCT00824512 Completed - Friedreich Ataxia Clinical Trials

Efficacy of EGb761 in Patients Suffering From Friedreich Ataxia

Start date: June 2008
Phase: Phase 2
Study type: Interventional

The purpose of this protocol is to determine the efficacy of EGb 761 120 mg bid versus placebo in patients suffering from Friedreich Ataxia

NCT ID: NCT00811681 Completed - Friedreich's Ataxia Clinical Trials

Effect of Pioglitazone Administered to Patients With Friedreich's Ataxia: Proof of Concept

ACTFRIE
Start date: December 2008
Phase: Phase 3
Study type: Interventional

Friedreich's ataxia (FA) is a rare progressive neurological disorder affecting approximately 1/30, 000 individuals. No treatment is presently available to counteract the neurodegeneration of this extremely severe disease. Pioglitazone, a well known PPAR gamma (peroxysome proliferators-activated receptor gamma) ligand induces the expression of many enzymes involved in the mitochondrial metabolism, including the superoxide dismutases. This agent may be therapeutic by counteracting the disabled recruitment of antioxidant enzymes in FA patients. This potential neuroprotective agent crosses the brain blood barrier in human. Primary objective: To explore the effects of Pioglitazone on neurological function in FA patients. We expect neurological benefits taking into account the natural course of the disease. Population: Subjects for this study will be limited to patients not older than 25 years Methodology: Prospective, randomized double-blind trial of Pioglitazone versus placebo in FA patients. Patients will be treated two years and will undergo clinical exams and testing during three days each six months at the clinical investigation centre.

NCT ID: NCT00803868 Terminated - Friedreich's Ataxia Clinical Trials

Pilot Study of Varenicline (Chantix®) in the Treatment of Friedreich's Ataxia

Start date: May 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine if varenicline is effective in treating symptoms of Friedreich's ataxia.

NCT ID: NCT00697073 Completed - Friedreich's Ataxia Clinical Trials

Study to Assess the Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients

IONIA-E
Start date: July 2008
Phase: Phase 3
Study type: Interventional

This study is meant to assess the safety and tolerability of idebenone in patients with Friedreich's Ataxia over a 12 months period.

NCT ID: NCT00631202 Completed - Friedreich's Ataxia Clinical Trials

Efficacy of Epoetin Alfa in Patients With Friedreich's Ataxia

Start date: February 2008
Phase: Phase 2
Study type: Interventional

Friedreich's ataxia is a rare genetic disorder characterized by severe neurological disability and cardiomyopathy. Friedreich's ataxia is the consequence of frataxin deficiency. Although several drugs have been proposed, there is no available treatment. It was recently demonstrated that erythropoietin can increase the intracellular levels of frataxin in an in-vitro model. The present project is aimed at testing the possible therapeutic approach of erythropoietin, which is an already available and commercialized drug. The investigators will perform both in-vitro and in-vivo tests, in order to asses its efficacy and safety in patients. The results will be useful to plan further clinical trials.

NCT ID: NCT00537680 Completed - Friedreich's Ataxia Clinical Trials

Study to Assess the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia

IONIA
Start date: December 2007
Phase: Phase 3
Study type: Interventional

This study is meant to assess the effectiveness of idebenone on neurological outcome measures in patients with Friedreich's Ataxia over a 6 months period.

NCT ID: NCT00530127 Completed - Friedreich's Ataxia Clinical Trials

A Study Investigating the Safety and Tolerability of Deferiprone in Patients With Friedreich's Ataxia

Start date: April 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of this study is to demonstrate the safety and tolerability of deferiprone in subjects with Friedreich's ataxia (FRDA). The secondary objective is to evaluate the efficacy of deferiprone for the treatment of FRDA, as assessed by a 9-Hole Peg Test (9HPT), Timed 25-Foot Walk (T25FW), Low-Contrast Letter Acuity test (LCLA), International Cooperative Ataxia Rating Scale (ICARS), and Friedreich's Ataxia Rating Scale (FARS). The tertiary objectives are to evaluate the effect of deferiprone on: 1. cardiac function as measured by changes in Left Ventricular Shortening Fraction (LVSF), Left Ventricular Ejection Fraction (LVEF) and Left Ventricular (LV) mass using echocardiogram (ECHO), 2. quality of life using quality-of-life surveys, and 3. functional status using Activities of Daily Living (ADL).