A Study of Resveratrol as Treatment for Friedreich Ataxia

NCT ID: NCT01339884

Last Updated: 2014-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to determine the effect of two doses of resveratrol taken for a 12 week period, on frataxin levels in individuals with Friedreich ataxia. This study will also measure the effect of resveratrol on markers of oxidative stress, clinical measures of ataxia, and cardiac parameters.

Detailed Description

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Resveratrol shows promise as an agent for the treatment of Friedreich ataxia due to its antioxidant properties, neuroprotective effects, and ability to increase frataxin levels in vitro and in vivo. This clinical pilot study aims to determine the effect of two doses of resveratrol (1g/day and 5g/day) taken for 12 weeks, on frataxin levels in individuals with Friedreich ataxia. Additional outcome measures include the effect of resveratrol on markers of oxidative stress, clinical measures of ataxia , and cardiac parameters (including relative wall thickness and left ventricular mass index).

Conditions

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Friedreich Ataxia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Resveratrol, 1g daily

15 participants will receive resveratrol 1g daily

Group Type ACTIVE_COMPARATOR

Resveratrol

Intervention Type DRUG

Resveratrol 1g daily (500mg twice daily) for 12 weeks Resveratrol 5 daily (2.5g twice daily) for 12 weeks

Resveratrol, 5g daily

15 participants will receive resveratrol, 5g daily

Group Type ACTIVE_COMPARATOR

Resveratrol

Intervention Type DRUG

Resveratrol 1g daily (500mg twice daily) for 12 weeks Resveratrol 5 daily (2.5g twice daily) for 12 weeks

Interventions

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Resveratrol

Resveratrol 1g daily (500mg twice daily) for 12 weeks Resveratrol 5 daily (2.5g twice daily) for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults with Friedreich ataxia due to homozygosity for the GAA repeat expansion in intron 1 of the FXN gene
* Functional stage on the Ataxia subscale of the FARS of 1 or higher

Exclusion Criteria

* Women who are pregnant or lactating
* Active arrythmias or significant cardiac insufficiency
* Use of idebenone, Coenzyme Q or vitamin E within 30 days prior to enrolment
* Use of amiodarone or other medications which may have clinically significant drug interactions that cannot be safely monitored
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Friedreich's Ataxia Research Alliance

OTHER

Sponsor Role collaborator

Murdoch Childrens Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Martin Delatycki

Prof Martin Delatycki

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Delatycki, MBBS PhD

Role: PRINCIPAL_INVESTIGATOR

Murdoch Childrens Research Institute

Locations

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Monash Medical Centre, Southern Health

Clayton, Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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10358B

Identifier Type: -

Identifier Source: org_study_id

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