Clinical Trials Logo

Clinical Trial Summary

The aim of this study is to assess the efficacy of micronised resveratrol as a treatment for FRDA, in terms of reducing the severity of ataxia symptoms at 24 weeks, through a randomised blinded, placebo controlled crossover trial.


Clinical Trial Description

Friedreich ataxia (FRDA) is the most common hereditary ataxia, with an estimated prevalence in Caucasians of 1 in 30,000. Neurological features of FRDA are progressive gait and limb ataxia, absent lower limb reflexes, and loss of position and vibration sense. There are currently no treatments proven to alter the natural history of FRDA. Resveratrol is a naturally occurring compound found in red wine, berries, and nuts. It is postulated to have wide-ranging health benefits, including antioxidant, anticarcinogenic, antidiabetic and neuroprotective properties. The study will be a double-blinded, placebo-controlled randomised 2-period crossover trial of 2g/day of micronised resveratrol in FRDA over 24 weeks. The study will enrol 40 patients with FRDA from 3 sites. The primary outcome measure is the change in modified Friedreich Ataxia Rating Scale (mFARS) score from baseline to 24 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03933163
Study type Interventional
Source Murdoch Childrens Research Institute
Contact
Status Completed
Phase Phase 2
Start date May 23, 2019
Completion date March 28, 2024

See also
  Status Clinical Trial Phase
Completed NCT05573698 - Study to Evaluate Multiple Ascending Dose and Multi-Dose of DT-216 in Adult Patients With Friedreich Ataxia Phase 1
Completed NCT00229632 - Idebenone to Treat Friedreich's Ataxia Phase 2
Completed NCT05579691 - A Double-Blind, Placebo-Controlled, Dose Exploration Study of CTI-1601 in Adult Subjects With Friedreich's Ataxia Phase 2
Completed NCT04273165 - Safety and Efficacy of Etravirine in Friedreich Ataxia Patients Phase 2
Not yet recruiting NCT05874388 - Characterisation of the Cognitive Profile of Patients Suffering From Friedreich's Ataxia N/A
Completed NCT02594917 - Genetic and Environmental Determinants That Control Metabolism in Pulmonary Hypertension
Completed NCT01716221 - An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia Phase 4
Active, not recruiting NCT05485987 - A Study of Vatiquinone for the Treatment of Participants With Friedreich Ataxia Phase 2
Completed NCT03214588 - Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich Ataxia Phase 2
Completed NCT03418740 - Neurology Measures in FA Children
Not yet recruiting NCT06054893 - A Study of Omaveloxolone in Children With Friedreich's Ataxia Phase 1
Recruiting NCT04921930 - Evaluation of the Effect of Artesunate in Friedreich Ataxia (FA) Phase 1/Phase 2
Completed NCT02705547 - Rosuvastatin (Crestor) in Friedreich Ataxia Early Phase 1
Completed NCT02035020 - A Phase IIa Trial to Test Safety and Efficacy Interferon Gamma Treatment in Elevating Frataxin Levels in FRDA Patients Phase 2
Completed NCT00015808 - Safety Study of Idebenone to Treat Friedreich's Ataxia Phase 1
Completed NCT04817111 - NAD+ Precursor Supplementation in Friedreich's Ataxia Phase 2
Active, not recruiting NCT05168774 - FRDA Investigator Initiated Study (IIS) With Elamipretide Phase 1/Phase 2
Completed NCT03917225 - A Clinical Study to Evaluate the Effect of MIN-102 on the Progression of Friedreich's Ataxia in Male and Female Patients Phase 2
Completed NCT00224640 - Iron-Chelating Therapy and Friedreich Ataxia Phase 1/Phase 2
Completed NCT00056186 - Transitional Life Events in Patients With Friedreich's Ataxia: Implications for Genetic Counseling N/A