The EHDN endorsed European ACR-16 trial ('MermaiHD') is on the final leg of enrolling participants in the study: the last of the planned 420 participants was hoped to be screened no later than March 31, 2009. Therefore EHDN would like to alert members in countries participating in the MermaiHD trial to inform interested HD patients about the study and the contact details of the study sites contributing to MermaiHD.

Below please find flyers in English, French, German, Italian, Portugues and Spanish that are intended to assist you in informing potential participants about the study.

Flyer ACR-16 Trial
Downloadable Flyer for the ACR-16 trial
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The European Huntington’s Disease Network Endorses a Phase III Clinical Trial of ACR-16 for the Symptomatic Treatment of Huntington’s Disease (October 1, 2007, Ulm)

October 1, 2007, Ulm, Germany – The European Huntington’s Disease Network (EHDN) announced today the official endorsement of a Phase III clinical trial of ACR-16 for the symptomatic treatment of Huntington’s Disease. Neurosearch, a company based in Denmark, is conducting the trial.

Before reviewing the proposal, the Scientific and Bioethics Advisory Committee (SBAC) of the EHDN developed criteria for evaluating clinical trials. These criteria may be viewed on the web site of the EHDN Scientific and Bioethics Advisory Committee. Endorsement by the EHDN involves a review by the SBAC of whether a proposed clinical trial meets these criteria. After reviewing the Neurosearch proposal, the SBAC offered suggestions for improving the proposed trial. Based on these comments, the Executive Committee (EC) of the EHDN issued a conditional endorsement. NeuroSearch responded positively to the SRC’s suggestions and proposed a revised clinical trial plan. This revised clinical trial plan is endorsed by the EHDN.

ACR-16 belongs to a novel class of drugs, characterised as dopaminergic stabilisers, CNS active compounds that can both enhance and counteract dopaminergic effects in the brain depending on the initial level of dopaminergic activity. Thus, they have the ability to stabilize behavioural and motor disturbances caused by neurological and psychiatric disorders. They do this in pathological states without compromising normal thought processes or motor functions. ACR-16 has been successfully investigated in a Phase II multi-centre, randomised and placebo-controlled trial in patients with Huntington’s disease as well as in three Phase Ib studies within Huntington’s disease, Parkinson’s disease and schizophrenia respectively.

The sponsoring company, NeuroSearch, has filed a Clinical Trial Application (CTA) in Europe for the initiation of Phase III clinical studies. The European Phase III programme will involve multiple centres in several countries, including the United Kingdom, Germany, Austria, France, Belgium, Portugal and Spain.
The European Phase III programme is planned as a randomised, double-blind, placebo-controlled study of ACR-16 (45 mg or 90 mg daily dosing) for the symptomatic treatment of Huntington’s disease. Approximately 420 patients are planned to be enrolled in the study, and dosing will continue for six months. The selected primary endpoint in the Phase III programme is the change from baseline in the modified Motor Score (mMS) subscale of the Unified Huntington’s Disease Rating Scale (UHDRS). Secondary objectives are to assess effects on the patients’ overall improvement, behaviour, symptoms of depression and anxiety, and cognitive functions as well as to assess the safety and tolerability of ACR-16.

NeuroSearch is also preparing an Investigational New Drug (IND) application to the FDA for a three-month clinical study in the US. The US and European studies are planned to provide the basis for international market authorisations (MA) on ACR-16 for the symptomatic treatment of Huntington’s disease.

The EHDN is an independent and not-for-profit network that serves as a platform for clinicians, scientists and organizations for families affected by HD to collaborate in support of preclinical and clinical research on HD.