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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
Scientific title
An Open Label Clinical Pilot Study of Resveratrol as Treatment for Friedreich Ataxia
Secondary ID [1] 0 0
10358B
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Friedreich Ataxia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Neurological 0 0 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Lymphocyte frataxin level
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Oxidative stress markers
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Clinical rating scales of ataxia
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Echocardiogram measures
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Pharmacokinetic studies of resveratrol
Timepoint [4] 0 0
First 2 hours post dose

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre, Southern Health - Clayton, Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Clayton, Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Friedreich's Ataxia Research Alliance
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Martin Delatycki, MBBS PhD
Address 0 0
Murdoch Childrens Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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