Drug/indication: Pimavanserin in Parkinson's disease psychosis (phase III study)
Top-line results expected in the third quarter of 2012
The "020" trial compares pimavanserin against placebo in patients suffering from psychosis due to Parkinson's disease. The primary endpoint is the reduction in antipsychotic behavior measured using the Scale for the Assessment of Positive Symptoms (SAPS).
Two previous phase III studies of pimavanserin in patients with Parkinson's psychosis failed to demonstrate a statistically significant benefit. The ongoing "020" study was designed to diminish the effect of a placebo response and produce data that are less subject to variability.
Amicus Therapeutics ( FOLD)
Drug/indication: migalastat (Amigal) in Fabry disease
Top-line results expected in the third quarter 2012
"Study 011" compares migalastat to a placebo in patients with Fabry disease. A second phase III study "013" compares migalastat against current standard-of-care therapies for Fabry disease, Fabrazyme or Replagal.