This will be a multi-center, randomized, blinded, comparative, placebo-controlled, 4 arm
crossover study in patients with primary insomnia.
Inclusion Criteria:
- Be between the ages of 21 and 64 years, inclusive;
- Have a body mass index (BMI) between 21 and 34 kg/m2, inclusive;
- Be a primary insomniac as defined by DSM-IV criteria; in particular difficulty
with both sleep initiation and sleep maintenance;
- Have subjective Latency to Sleep Onset > 45 minutes;
- Have a mean habitual subjective TST of <6. 5 hours;
- Have a TST of 240 - 420 minutes at each of two baseline PSGs;
- Have a mean LPS > 20min, with neither value <15 minutes and mean WASO > 40 minutes on
baseline PSGs;
- Be in good general health as determined by a thorough medical history and physical
examination (including vital signs), 12-lead ECG and clinical laboratory tests;
- Have clinical laboratory values within normal reference range or not clinically
significantly abnormal as judged by the Principal Investigator;
- Be off any investigational drug for at least 30 days prior to screening;
- If the patient is a female of childbearing potential, she must be using an acceptable
method of contraception, must have a negative serum pregnancy test at screening, and
must have a negative urine pregnancy test before randomization.
- Female patients who have been surgically sterilized or have had a hysterectomy are
eligible if they have a negative pregnancy test at screening;
- Be able to read, understand, and provide written/dated informed consent before
enrolling in the study, and must be willing to comply with all study procedures.
Exclusion Criteria:
- Clinically significant unstable medical illness;
- Evidence or history of clinically significant allergic (except for untreated,
asymptomatic, seasonal allergies at time of dosing), hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological
disease;
- History of cancer other than basal cell carcinoma, squamous cell carcinoma of the skin
or cancer in situ within 5 years of screening;
- Supine or sitting blood pressure > 140/90 mmHg at the screening or baseline visits;
- Heart rate >100 bpm at the screening or baseline visits;
- Within the past three years, clinically significant psychiatric illness, including
chronic psychiatric illness or any Axis I condition;
- History or presence of chronic pain;
- History of epilepsy or serious head injury;
- Other than primary insomnia, a history of clinically significant sleep disorder
including narcolepsy, parasomnia as an adult, circadian rhythm disorder, restless leg
syndrome, or on the initial baseline PSG, sleep apnea [Apnea Hypopnea Index (AHI) >10]
or Periodic Limb Movement Disorder [Periodic Limb Movement Arousal Index (PLMAI) >
10];
- Any condition that may affect drug absorption;
- Smokers who habitually smoke more than 10 cigarettes per day or smoke during the
overnight hours;
- Travel across more than three time zones, an expected change in sleep schedules of 3
hours or more, or involvement in rotating shift work within 14 days prior to screening
or during the study period;
- Self-report of napping ≥30 minutes more than 2 times per week within the last month;
- Any clinically significant abnormal finding on physical examination, vital signs, ECG,
or clinical laboratory tests, as determined by the investigator. (The QTc interval
must be ≤430 msec. for males and ≤450 msec for females);
- Known or suspected diagnosis of Acquired Immune Deficiency Syndrome, or previous or
current positive result on human immunodeficiency virus antibody or antigen testing;
- History or laboratory finding of positive hepatitis B surface antigen or hepatitis C
core antibody;
- History of allergies, or known sensitivity, hypersensitivity, or adverse reaction to
any drug similar to adipiplon, including benzodiazepines, or zolpidem, zaleplon,
zopiclone, or eszopiclone;
- Use of any psychotropic medications, including over-the-counter (OTC) and herbal
products, that may affect sleep/wake function within one week or five half-lives
(whichever is longer) prior to screening or need to use any of these medications at
any time during the study;
- Pregnant or lactating females;
- Positive serum pregnancy test at screening or urine pregnancy test at baseline;
- Recent history (≤ one year) of alcohol or drug abuse, or current evidence of substance
dependence or abuse as defined by DSM-IV criteria;
- Regular consumption of large amounts of xanthine-containing substances (i. e. more than
5 cups of coffee or equivalent amounts of xanthine-containing substances per day);
- Have eaten grapefruit or had grapefruit juice from baseline through the completion of
study dosing;
- Self report of a usual consumption of more than 14 units of alcohol per week;
- Requiring the concomitant usage of any 3A4 inhibitors;
- Any prior exposure to adipiplon (formerly known as NG2-73).
Miami Research Associates, South Miami, Florida 33143, United States; Recruiting
Broward Research Group, Pembroke Pines, Florida 33026, United States; Not yet recruiting
Neurotrials Research, Inc, Atlanta, Georgia 30342, United States; Recruiting
Sleep and Behavior Medicine Institute, Vernon Hills, Illinois 60061, United States; Recruiting
Vince & Associates Clinical Research, Overland Park, Kansas 66212, United States; Recruiting
St. Luke's Hospital Sleep Medicine and Research Center, Chesterfield, Missouri 63017, United States; Not yet recruiting
Clinilabs, Inc., New York, New York 10019, United States; Recruiting
Tri-State Sleep Disorders Center, Cincinnati, Ohio 45246, United States; Recruiting
Lynn Health Science Institute, Oklahoma City, Oklahoma 73112, United States; Recruiting
