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Intra-Cellular Therapies Reports Positive Final Results of a Phase II Clinical Trial with ITI-007 in Patients with Sleep Maintenance Insomnia
Date:3/10/2009

p in a wide variety of diseases where sleep improvement may be beneficial."

"A majority of insomnia patients, especially the elderly and those with comorbid conditions, have difficulty staying asleep throughout the night," said Thomas Roth, Ph.D., Director of Research, Chief of Sleep Medicine for the Henry Ford Hospital Sleep Disorders and Research Center. "These data show that ITI-007 can maintain sleep without impairing next day functioning."

SUMMARY OF PHASE II SMI RESULTS

ITI-007 is an orally available investigational new drug being developed at low doses for the treatment of insomnia characterized by difficulty staying asleep, also referred to as sleep maintenance insomnia, and for insomnia associated with psychiatric disorders such as depression and post-traumatic stress disorder, and insomnia associated with neurologic disorders such as traumatic brain injury, Parkinson's disease, Alzheimer's disease and mild cognitive impairment. Previously announced interim results showed that patients with SMI treated with ITI-007 experienced dose-dependent increases in slow wave sleep (SWS) and dramatic decreases in wake after sleep onset (WASO) as determined by PSG. The final analysis (N=19) confirmed these results, meeting the primary and key secondary endpoints of the trial, and extended the findings to demonstrate remarkable efficacy in this patient population.

This Phase II trial was a double-blind, placebo controlled, 4-way crossover design comparing placebo to 3 doses of ITI-007 (1 mg, 5 mg and 10 mg) in patients with SMI. Analysis of key objectives in this study indicated that ITI-007 dose-dependently and significantly increased SWS (p=0.002) and decreased WASO (p=0.001). Consistent with the significant decrease in WASO, ITI-007 showed a statistical trend to decrease the number of awakenings (p=0.071). These large decreases in WASO also were reflected in the PSG recordings by increased tot
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SOURCE Intra-Cellular Therapies, Inc.
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