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

ISRCTN ISRCTN79170611
DOI https://doi.org/10.1186/ISRCTN79170611
Secondary identifying numbers LA01.01.0005
Submission date
03/02/2003
Registration date
03/02/2003
Last edited
09/02/2011
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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHuntington's disease
InterventionTwo 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2003
Completion date01/01/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/01/2003
Date of final enrolment01/01/2004

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Laxdale Ltd
Stirling
FK7 9JQ
United Kingdom

Sponsor information

Laxdale Ltd (UK)
Industry

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

Phone +44 (0)1786 476001
Email admin@Laxdale.co.uk
Website http://www.laxdale.co.uk
ROR logo "ROR" https://ror.org/03gc62f43

Funders

Funder type

Industry

Laxdale Ltd (UK)

No information available

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 26/07/2005 Yes No