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CaptainObvious

11/04/14 2:15 PM

#22424 RE: CaptainObvious #22423

Here is an example from earlier this year:
Janssen Investigational Treatment for Schizophrenia Shows Positive Efficacy, Delays Relapse
Independent Data Monitoring Committee Recommends Halting Trial and Unblinding Data Based on Treatment Efficacy

TITUSVILLE, N.J., March 20, 2014 /PRNewswire/ -- Janssen Research & Development, LLC announced today that following an Independent Data Monitoring Committee (IDMC) recommendation based on positive efficacy, it has halted early a Phase 3 clinical study of paliperidone palmitate 3-month formulation, an investigational treatment for symptoms of schizophrenia in adults.

"We are really excited about this news because a medication's ability to delay time to relapse in schizophrenia has significant clinical and societal implications," said Husseini K. Manji, MD, Global Head, Neuroscience, Janssen Research & Development. "Being able to delay relapse can prove to be beneficial clinically to patients, to their caregivers and to the community."

The international, randomized, multicenter, double-blind clinical trial evaluated the efficacy of paliperidone palmitate 3-month formulation compared with placebo in delaying time to first occurrence of relapse of symptoms of schizophrenia. Study patients who were randomized to treatment were first stabilized with INVEGA® SUSTENNA® (paliperidone palmitate one-month formulation), an approved treatment for schizophrenia, prior to receiving the investigational 3-month formulation................