A multicentre, multinational, double blind, randomised, parallel group, placebo-controlled study of ethyl-eicosapentaenoate (EPA) in patients with Huntington's disease (HD)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Harald Murck
Scientific

Laxdale Ltd
Kings Park House
Laurelhill Business Park
Polmaise Road
Stirling
FK7 9JQ
United Kingdom

Phone	+44 (0)1786 476001
Email	hmurck@laxdale.co.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Huntington's disease
Intervention	Two groups randomly allocated to placebo or 2 g/day ethyl EPA on a double blind basis. Patients who completed the 12 month randomisation phase of the trial were invited to take part in a further 12 month open label phase receiving 2 g/day Ethyl EPA.
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	1. Written informed consent 2. Availability of a responsible family member or carer to look after the patient during the trial and ensure complete compliance 3. Diagnosis of HD in stage I
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2003
Date of final enrolment	01/01/2004

Laxdale Ltd

Stirling
FK7 9JQ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	26/07/2005		Yes	No