E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010331 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
To examine the effect of ethyl-EPA versus placebo on Chorea (as measured by the UHDRS-TMS Subscale)over a period of 6 months To 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 months To examine the effect of ethyl-EPA versus placebo on the Clinical Global Impressions (CGI) score over a period of 6 months. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Written informed consent. - Aged 35 or older of either gender - Has 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.
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E.4 | Principal 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-TR - Score 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 1 - Treatment 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in TMS-4 over 6 months |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Amendment 1: Open-label extension |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |