High dose Coenzyme Q10 and vitamin E therapy in Friedreich's ataxia

ISRCTN ISRCTN87024790
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

Department of Clinical Neurosciences
Royal Free & University College Medical School
Rowland Hill Street
London
NW3 2PF
United Kingdom

Study information

Study designRandomised double blind controlled trial, involving 2 arms; high doses of coenzyme Q10 / vitamin E; low doses of coenzyme Q10 / vitamin E
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymQES4
Study objectivesHigh 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) studiedFriedreich's ataxia
InterventionHigh doses of coenzyme Q10 / vitamin E vs Low doses of coenzyme Q10 / vitamin E
Intervention typeSupplement
Primary outcome measureSignificant 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 measures1. 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 date01/09/2001
Completion date01/05/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants50
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2001
Date of final enrolment01/05/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Clinical Neurosciences
London
NW3 2PF
United Kingdom

Sponsor information

Royal Free Hospital Trust (UK)
Hospital/treatment centre

Royal Free Hospital Trust
Pond Street
London
NW3 2PF
England
United Kingdom

ROR logo "ROR" https://ror.org/04rtdp853

Funders

Funder type

Charity

Ataxia UK (UK)
Private sector organisation / Other non-profit organizations
Alternative name(s)
Ataxia
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2008 Yes No