High dose Coenzyme Q10 and vitamin E therapy in Friedreich's ataxia
ISRCTN | ISRCTN87024790 |
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DOI | https://doi.org/10.1186/ISRCTN87024790 |
Secondary identifying numbers | FAQES4 |
- Submission date
- 10/01/2007
- Registration date
- 01/02/2007
- Last edited
- 27/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Anthony Schapira
Scientific
Scientific
Department of Clinical Neurosciences
Royal Free & University College Medical School
Rowland Hill Street
London
NW3 2PF
United Kingdom
Study information
Study design | Randomised double blind controlled trial, involving 2 arms; high doses of coenzyme Q10 / vitamin E; low doses of coenzyme Q10 / vitamin E |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study acronym | QES4 |
Study objectives | High doses of coenzyme Q10 and vitamin E given daily over two years will modifiy disease progression in patients with genetically proven Friedreich's ataxia. |
Ethics approval(s) | The Royal Free Local Research Ethics Committee (UK), Ref 5405, approved 16/05/2001. |
Health condition(s) or problem(s) studied | Friedreich's ataxia |
Intervention | High doses of coenzyme Q10 / vitamin E vs Low doses of coenzyme Q10 / vitamin E |
Intervention type | Supplement |
Primary outcome measure | Significant improvement in the rate of change in the International Cooperative Ataxia Ratings Scale (ICARS) scores over two years of the trial in the high dose versus the low dose treatment groups |
Secondary outcome measures | 1. Rate of change in the kinetic, posture and gait, speech, ocular subscores of the ICARS 2. Rate of change in the following: a. speech tests (PaTa repetition, speed of reading) b. upper limb coordination tests (hand clicker, modified peg board, hand target, BRAIN kinesia) c. lower limb coordination tests (foot target, box) d. cardiac tests (IVS, PWd and fraction shortening) e. activities of daily living scale |
Overall study start date | 01/09/2001 |
Completion date | 01/05/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 50 |
Key inclusion criteria | 1. Homozygous for the GAA expansion in the FRDA gene characteristic of the disease 2. Able and willing to attend the assessments over the trial period 3. Over 10 years of age at the start of the trial |
Key exclusion criteria | 1. Planned surgery during the trial period 2. An ICARS score greater than 80% of the maximum 3. Taking coenzyme Q10, vitamin E or other antioxidants 4. Planned pregnancy |
Date of first enrolment | 01/09/2001 |
Date of final enrolment | 01/05/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Clinical Neurosciences
London
NW3 2PF
United Kingdom
NW3 2PF
United Kingdom
Sponsor information
Royal Free Hospital Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Royal Free Hospital Trust
Pond Street
London
NW3 2PF
England
United Kingdom
https://ror.org/04rtdp853 |
Funders
Funder type
Charity
Ataxia UK (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Ataxia
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/12/2008 | Yes | No |