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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01339884
Registration number
NCT01339884
Ethics application status
Date submitted
14/04/2011
Date registered
21/04/2011
Date last updated
22/01/2014
Titles & IDs
Public title
A Study of Resveratrol as Treatment for Friedreich Ataxia
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Scientific title
An Open Label Clinical Pilot Study of Resveratrol as Treatment for Friedreich Ataxia
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Secondary ID [1]
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10358B
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Friedreich Ataxia
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Condition category
Condition code
Neurological
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Other neurological disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Neurological
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Neurodegenerative diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Resveratrol
Active comparator: Resveratrol, 1g daily - 15 participants will receive resveratrol 1g daily
Active comparator: Resveratrol, 5g daily - 15 participants will receive resveratrol, 5g daily
Treatment: Drugs: Resveratrol
Resveratrol 1g daily (500mg twice daily) for 12 weeks Resveratrol 5 daily (2.5g twice daily) for 12 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Lymphocyte frataxin level
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Assessment method [1]
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Change in lymphocyte frataxin levels at 12 weeks compared to baseline
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Timepoint [1]
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12 weeks
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Secondary outcome [1]
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Oxidative stress markers
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Assessment method [1]
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Oxidative stress, as measured by a) plasma F2-isoprostanes and b) urinary 8-hydroxyl-2-deoxyguanosine levels at 12 weeks compared to baseline
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Timepoint [1]
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12 weeks
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Secondary outcome [2]
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Clinical rating scales of ataxia
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Assessment method [2]
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Clinical rating scales of ataxia at 12 weeks will be compared to baseline. This will include: a) Friedreich Ataxia Rating Scale (FARS) b) International Cooperative Ataxia Rating Scale (ICARS) c) Scale for the Assessment and Rating of Ataxia (SARA) d) Friedreich Ataxia Functional Composite
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Timepoint [2]
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12 weeks
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Secondary outcome [3]
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Echocardiogram measures
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Assessment method [3]
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Changes in structural and functional 3D echocardiogram measures from baseline to 12 weeks will be reported
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Timepoint [3]
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12 weeks
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Secondary outcome [4]
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Pharmacokinetic studies of resveratrol
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Assessment method [4]
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Pharmacokinetic data will be collected 45, 90 and 120 minutes after the first dose of resveratrol. Plasma concentration of resveratrol and its sulfate and glucuronide metabolites will be measured in ng/mL.
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Timepoint [4]
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First 2 hours post dose
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2012
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Sample size
Target
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Accrual to date
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Final
27
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Medical Centre, Southern Health - Clayton, Melbourne
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Recruitment postcode(s) [1]
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3168 - Clayton, Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Friedreich's Ataxia Research Alliance
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01339884
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Martin Delatycki, MBBS PhD
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Address
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Murdoch Childrens Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01339884
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