|
NeuroSearch presents additional data from the MermaiHD study with Huntexil® at the 5th Annual CHDI Conference on Huntington's disease
11 February 2010 - Press release
PDF version
Copenhagen, 11 February 2010 – Today, at the 5th Annual CHDI Conference on Huntington's disease, held 8 to 11 February in Palm Springs, California, NeuroSearch (NEUR.CO) presented the results from the MermaiHD study, a Phase III study with Huntexil® (pridopidine) for the treatment of Huntington's disease. Top-line results from the study were announced on 3 February 2010 (Announcement no. 01-10),
Presenting as the featured speaker at the conference, Dr. Joakim Tedroff, Head of Clinical Science at NeuroSearch on Wednesday 10 February, 4pm to 5pm PDT (Thursday, 1am to 2am CET) presented the study results, including the following:
· Efficacy - Results from the MermaiHD study demonstrate that six months' (26 weeks) treatment with Huntexil® (45 mg BID), in Huntington's patients significantly improves both voluntary movement control, as measured on the primary endpoint, the mMS, and also a broader range of voluntary and involuntary motor symptoms, including dystonia and eye movements. Measured in both the ITT (Intention to treat) and the PP (per protocol, 82% of patients)) populations, the improvements seen were highly statistically significant, and thereby the results in the PP population fully confirm the ITT analysis :
|
Motor scale
|
Significance level for the PP population
|
Significance level for the ITT population
|
|
Modified Motor Score, mMS
|
p <0.005
|
p <0.02
|
|
Total Motor Score, TMS
|
p <0.005
|
p <0.001
|
|
Eye Movements
|
p <0.02
|
p <0.002
|
|
Dystonia
|
p <0.01
|
p <0.001
|
· Cognitive testing – On one of the cognitive measures, the Trail Making test, included in the MermaiHD study as a secondary endpoint, six months treatment with Huntexil® 45mg BID showed a significant improvement (ITT; p <0.05).
· Safety and compliance – Over the six months of treatment in the study, less than two thirds of all patients reported adverse events. The most frequently observed adverse events were falls, dizziness, Huntington's chorea, diarrhoea, nausea, nasopharyngitis, depression, fatigue and insomnia, occurring at a frequency between 3% and 9% and equally distributed between the active treatment groups and placebo. In total, the study had a high completion rate, and with less than 4% of patients withdrawing from the study due to adverse events:
|
|
Placebo
|
Huntexil®
45 mg QD
|
Huntexil®
45 mg BID
|
|
Randomised pts (ITT)
|
144
|
148
|
145
|
|
Completers
|
129 (90%)
|
143 (97%)
|
131 (90%)
|
|
Withdrawals due to AE
|
8 (6%)
|
2 (1%)
|
7 (5%)
|
|
Any adverse event
|
64%
|
|
