Full title of the trial : A multicentre, multi-national, double-blind, randomised, parallel group placebo-controlled trial of ethyl-EPA (ethyl-icosapent) in patients with Huntington’s Disease

• Register: EUCTR
• Last refreshed on: 1 May 2012
• Main ID: EUCTR2005-002088-98-PT
• Date of registration: 16/03/2006
• Prospective Registration: Yes
• Primary sponsor: Amarin Neuroscience Ltd
• Public title: Full title of the trial : A multicentre, multi-national, double-blind, randomised, parallel group placebo-controlled trial of ethyl-EPA (ethyl-icosapent) in patients with Huntington’s Disease
• Scientific title: Full title of the trial : A multicentre, multi-national, double-blind, randomised, parallel group placebo-controlled trial of ethyl-EPA (ethyl-icosapent) in patients with Huntington’s Disease
• Date of first enrolment: 07/06/2006
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002088-98
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany, Italy, Portugal, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Written informed consent.
Aged 35 or older of either genderHas clinical features of Huntington’s Disease (HD) and a confirmatory family history of HD, and/or a CAG repeat expansion greater than or equal to 36.
Maximal dystonia score of 2 or less in both trunk and extremities items.Chorea score of at least 2 in at least one extremity item.
Maximal bradykinesia score of 2 or less in each of the items: body, pronation/supination and finger tapping
Able to travel to the assessment centre and judged by the Investigator as likely to be able to continue to travel for the duration of the trial.
Not considered to have major depression as defined in the DSM-IV-TRNot considered at risk of suicide (must not score positive for item A9 on the DSM-IV-TR).
Treatment with neuroleptics (including atypical neuroleptics) is excluded, except when taken at a stable dose for 4 weeks or more prior to visit 1.
Not taking tetrabenazine, omega–3 supplements, anticoagulant medication, steroids (other than topical preparations), selenium supplements >55mcg/day, magnesium supplements >150mg/day (including NMDA antagonists), lithium, antiepileptic medication and benzodiazepines. However, benzodiazepines are allowed if taken on a regular basis at a low dose for insomnia e.g. valium 5mg, temazepam 10mg, diazepam and lorazepam 1mg taken at night.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Unable to give written informed consent.
Requires 24 hour care and usually bedridden
Unlikely to comply with trial visit schedule or with trial medication due to irritability, symptoms of depression or other reason(s)
Diagnosis of major depressive disorder as defined in the DSM-IV-TRScore positive for item A9 on the DSM-IV-TR
Severe intercurrent illness which, in the opinion of the Investigator, may put the patient at risk when participating in the trial or may influence the results of the trial or affect the patients’ ability to take part in the trial.
Clinically significant, abnormal, baseline laboratory result(s), which in the opinion of the Investigator affect(s) the patients suitability for the trial e.g. abnormal TSH.
Females who, in the opinion of the Investigator, have the potential of childbearing but are not taking adequate contraceptive precautions; or who are pregnant or lactating.
Alcohol and / or drug abuse as defined in theDSM IV criteria for substance abuse - applies to alcohol and / or any illicit drug, including cannabis within the last 12 months.
Omega 3 supplementation within 4 weeks of visit 1 and throughout the trial period.
Treatment with tetrabenazine – current or within 4 weeks of visit 1.Treatment with neuroleptics (including atypical neuroleptics) except when taken at a stable dose for 4 weeks or more prior to visit 1Treatment with benzodiazepines on a regular basis within 8 weeks of visit 1, except when used at a low doses for insomnia e.g. valium 5mg, temazepam 10mg, diazepam and lorazepam 1mg at night.
Treatment with steroids (other than topical preparations) – current or within 4 weeks of visit 1.
Selenium supplementation > 55mcg/day within 4 weeks of visit 1.
Magnesium supplementation >150mg/day, riluzole or NMDA antagonists (memantine and amantadine) within 4 weeks of visit 1.
Treatment with lithium medication – current or within 6 months of visit 0.
Treatment with antiepileptic medication – current or within 6 months of visit 0.
Have participated in another interventional clinical trial or taken Investigational Medication in the last 3 months.
Have participated in any clinical trial with ethyl-EPA.Known allergy to any ingredients of the trial medication or placebo.
Currently taking anticoagulants.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

HUNTINGTON’S DISEASE
MedDRA version: 8.0 Level: LLT Classification code 10010331

Intervention(s)

Product Name: Ethyl-EPA
Product Code: LAX-101
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Ethyl Icosapent
Other descriptive name: Ethyl-EPA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 485-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Change from baseline in TMS-4 over 6 months

Main Objective: To examine the effect of ethyl-EPA versus placebo on the motor phenotype of HD patients as measured by the TMS-4 derived from the UHDRS-Total-Motor-Score (TMS) over a period of 6 months.

Secondary Objective: To examine the effect of ethyl-EPA versus placebo on Chorea (as measured by the UHDRS-TMS Subscale)over a period of 6 monthsTo examine the effect of ethyl-EPA versus placebo on the Total Motor Score component (TMS) of the Unified Huntington’s Disease Rating Scale (UHDRS) over a period of 6 monthsTo examine the effect of ethyl-EPA versus placebo on the Clinical Global Impressions (CGI) score over a period of 6 months.

Secondary ID(s)

AN01.01.0012

2005-002088-98-GB