A randomized, double-blind, placebo-controlled, 4-way crossover study of ITI-007 in subjects with sleep maintenance insomnia

• Conditions: Sleep maintenance disorders; MedDRA version: 9.1Level: LLTClassification code 10040984Term: Sleep disorder

• Registration Number: EUCTR2007-004640-78-FR
• Lead Sponsor: Intra-Cellular Therapies, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

? Males aged 18 to 65 years, inclusive,
? Females aged 18 to 65 inclusive, must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year post-menopausal),
? based on subject information, the patient has spent at least 6.5 hours and not more than 9.0 hours in bed, each night, with no more than 2 hour variability in 5 out of 7 nights over the preceding 2 weeks,
? subjects must be experiencing at least one hour of wakefulness after sleep onset at least 3 nights per week over the preceding month with a subjective total sleep time of 6.5 hours or less,
? subjects must report an impact associated with sleep maintenance insomnia, as measured by a score of at least at 2 or higher on at least one of the Questions # 2, 3, 4, or 5 of the Insomnia Severity Index (with the whole scale being administered to define baseline insomnia),
? subjects must report a usual bedtime of between 9 pm and midnight,
? subjects must have a body-mass index (BMI) between >19 and <34 kg/m2,
? subjects must be able to give informed consent,
? screening polysomnography criteria: PSG WASO > 45 min, PSG TST between 4 and 7 hours, inclusive, based on screening/baseline PSG criteria,
? subjects must be affiliated with, or beneficiary of, a French social security system.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? likely allergy or sensitivity to ITI-007 based on known allergies to drugs of the same class, or which in the opinion of the Investigator, suggests an increased potential for an adverse hypersensitivity to ITI-007,
? females who are lactating/breast feeding or who are pregnant, or of child bearing potential,
? history of drug or alcohol dependence within 12 months of study start or a positive screening test for alcohol (breathalyzer) or positive urine drug screen,
? history or current diagnosis of primary hypersomnia, restless leg syndrome, periodic leg movements with arousals (PLMA), narcolepsy, rapid eye movement (REM) motor dysfunction disorder, circadian rhythm sleep disorder, breathing related sleep disorder, or parasomnias,
? history or current diagnosis of stroke, head trauma, seizure disorder, or other neurological disorder considered clinically relevant,
? subjects with current diagnosis and treatment of Axis I psychiatric disorder (for example, schizophrenia, mood disorders, anxiety disorders, eating disorders, etc) other than insomnia,
? subjects with acute or chronic pain resulting in insomnia,
? shift work and/or recent significant travel across three or more time zones within the prior 2 weeks,
? napping 3 or more times during the day or self reported napping of >45 min per day,
? evidence of any clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder, or any condition that may interfere with the absorption, metabolism, distribution or excretion of the study drug, or may affect patient safety,
? a positive test for hepatitis B (HBs antigens),C (HCV antibodies), or HIV,
? consumption of xanthine –containing beverages (e.g., tea, coffee, or caffeine containing soft drinks) comprising usually more than 5 cups/glasses or > 1 liter per day,
? clinically significant and abnormal ECG (including prolonged QTcB > 450 msec male and > 470 msec female),
? any clinically significant abnormality in laboratory examinations, or vital signs performed at screening,
? smoking more than 10 cigarettes (or equivalent) per day,
? use of any of the following medications within the prior two weeks of screening: benzodiazepines, zolpidem, (es)zopiclone, modafinil, gabapentin, gaboxadol, mianserin, mirtazepine, cyproheptadine, ramelteon, herbal preparations (e.g., St. John’s Wort, valerian root, and kava kava), over the counter sleep preparations (e.g., antihistamines, decongestants, and anticholinergics), or melatonin,
? use of any investigational drug within 90 days prior to study entry or participation in a previous study with ITI-007,
? history of blood donation (> = 500 ml) within 90 days prior to study entry,
? PSG TST < 4 hours or > 7 hours, PSG WASO < = 45 minutes each night, Apnea-hypopnea index (AHI) > 10 or periodic leg movements with arousals index (PLMAI) > 15, based on screening/baseline PSG criteria,
? any subject judged by the principal investigator (PI) to be inappropriate for the study,
? any subject being in the exclusion related to participation in investigational drug studies according to the French National File for Healthy Subjects (total annual amount higher than 4500 Euros).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified