You are here

Phase 3 Clinical Trial for Tramiprosate Undergoing Analysis

LAVAL, QC, April 19 /PRNewswire-FirstCall/ -- Neurochem Inc. (NASDAQ: NRMX; TSX: NRM) announces that the database for the North American Phase III clinical trial for tramiprosate (ALZHEMED(TM)) for the treatment of Alzheimer's disease has been locked. The analysis is ongoing and entails employing an accurate statistical model that appropriately describes the data and provides accurate results. Neurochem has been advised by its external team of statisticians that adjustment to the initial statistical model, as set out in the statistical plan, would be necessary to provide accurate results. The procedure to arrive at a reliable model involves a detailed analysis of potential confounding factors such as the effect of concomitant medications, baseline characteristics of the study population or differences in clinical sites. Neurochem points out that potential refinement of the statistical model was discussed with the U.S. Food and Drug Administration before filing with the Agency and was anticipated in the plan filed.

The Company notes that in a clinical trial of the size, duration and complexity of the tramiprosate (ALZHEMED(TM)) Phase III study, such a process is not uncommon. The Company has been informed that it could take several weeks, perhaps longer, before the results are known. Neurochem continues to expect to announce these results during the second quarter of this year.

Source: Neurochem Inc.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs