NeuroSearch-announcement-30.12.10 

Independent review of the statistical analyses performed on the primary endpoint of the MermaiHD trial by a panel of EHDN-associated researchers

To ensure full transparency about the reported analysis of the primary endpoint; the modified motor score (mMS) of the MermaiHD study, NeuroSearch made all statistical data and the analyses performed available to a panel of EHDN-associated researchers (including investigators who did not participate in the trial) for independent review. The review is based on a quality controlled draft (draft 4) of the statistical report, including tables, figures, listings and raw analysis output. A final statistical report will be issued upon completion of the data set by the addition of quality-controlled CAG-repeat size information (currently missing) on 44 participants.  Since the primary analysis model of the endpoints does not include CAG as covariate, the inclusion of the missing CAG data by itself does not affect this review.

Based on the quality controlled draft of the statistical report

1. The panel confirms that the data were comprehensively described in the listings, tables, and figures and were found to be internally consistent
2. The panel is of the opinion that the statistical methods used to describe and to interpret the trial data were overall adequate
3. The panel is of the opinion that the analysis of the primary endpoint in both the ‘full analysis set’ population as well as in the ‘per protocol’ population was correctly reported in the company announcement of NeuroSearch dated 28.04.2010.

A manuscript giving a full account of the findings and intended for a peer reviewed journal has been drafted; several members of the review panel have actively contributed to the manuscript. Once a final statistical report will be available, the manuscript will be reviewed, revised (as appropriate) and submitted.

NeuroSearch announces the issuance of an EHDN statement supporting the statistical conclusions on the primary endpoint of the MermaiHD study

neurosearch announcement 04.09.2010_2 

Revision of first release

To ensure full transparency around the results and the conclusions drawn on the MermaiHD study, NeuroSearch has agreed to make all data and the statistical analyses performed available to a panel of EHDN-associated researchers for independent review. After completion of the review, EHDN will issue a statement reflecting the panel's conclusions.
The EHDN will aim for a full account of the review and the conclusions thereof to be given at the Plenary Meeting of the EHDN in September 2010.

NeuroSearch-revised-announcement-04.2010  


Press release: February 3, 2010

NeuroSearch announces positive top-line results from Phase III Huntexil® study in Huntington's disease (the MermaiHD study)

NeuroSearch-announcement-03.02.10