A multicentre, multinational, double blind, randomised, parallel group, placebo-controlled study of ethyl-eicosapentaenoate (EPA) in patients with Huntington's disease (HD)
ISRCTN | ISRCTN79170611 |
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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
Scientific
Laxdale Ltd
Kings Park House
Laurelhill Business Park
Polmaise Road
Stirling
FK7 9JQ
United Kingdom
Phone | +44 (0)1786 476001 |
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hmurck@laxdale.co.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
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 | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/2003 |
Completion date | 01/01/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | Not provided at time of registration |
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 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Laxdale Ltd
Stirling
FK7 9JQ
United Kingdom
FK7 9JQ
United Kingdom
Sponsor information
Laxdale Ltd (UK)
Industry
Industry
Kings Park House
Laurelhill Business Park
Polmaise Road
Stirling
FK7 9JQ
United Kingdom
Phone | +44 (0)1786 476001 |
---|---|
admin@Laxdale.co.uk | |
Website | http://www.laxdale.co.uk |
https://ror.org/03gc62f43 |
Funders
Funder type
Industry
Laxdale Ltd (UK)
No information available
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? |
---|---|---|---|---|---|
Results article | results | 26/07/2005 | Yes | No |