This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

ACADIA Announces Presentation Of Data From Its Pivotal Phase III Parkinson’s Disease Psychosis Study With Pimavanserin At The American Academy Of Neurology Annual Meeting

Safety and Tolerability Profile

Consistent with previous studies, pimavanserin was safe and well tolerated in the -020 Study. The most common adverse events were urinary tract infection (11.7% PBO vs. 13.5% PIM) and falls (8.5% PBO vs. 10.6% PIM). Adverse events were generally characterized as mild to moderate in nature. The only serious adverse events that occurred in more than one patient were urinary tract infection (1-PBO vs. 3-PIM) and psychotic disorder (0-PBO vs. 2-PIM). Over ninety percent of the patients who completed the clinical phase of this trial elected to roll over into the ongoing open-label safety extension study. Patients were only eligible to participate in the extension study if the treating investigator also deemed them to be likely to benefit from continued treatment with pimavanserin.

About the Trial Design

The pivotal Phase III trial, referred to as the -020 Study, was a multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy, tolerability and safety of pimavanserin as a treatment for patients with Parkinson’s disease psychosis. A total of 199 patients were enrolled in the study and randomized on a one-to-one basis to receive either 40 mg of pimavanserin or placebo once-daily for six weeks, following a two-week screening period including brief psycho-social therapy. Patients also received stable doses of their existing anti-Parkinson’s therapy throughout the study. The primary endpoint of the -020 Study was antipsychotic efficacy as measured using the “SAPS–PD” scale, which consists of nine items from the hallucinations and delusions domains of the Scale for the Assessment of Positive Symptoms, or SAPS. These nine items have been shown to be particularly relevant to the expression of psychotic symptoms in patients with Parkinson’s disease and to have high inter-rater reliability for assessment of severity. Motoric tolerability was a key secondary endpoint in the study and was measured using Parts II and III of the Unified Parkinson’s Disease Rating Scale, or UPDRS.

2 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG

Markets

Chart of I:DJI
DOW 16,521.25 -121.76 -0.73%
S&P 500 1,973.89 -14.98 -0.75%
NASDAQ 4,784.9430 -43.3820 -0.90%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs