Status:
TERMINATED
Efficacy and Safety Study of Adipiplon, Placebo and an Active Control in Primary Insomniacs
Lead Sponsor:
Neurogen Corporation
Conditions:
Primary Insomnia
Eligibility:
All Genders
21-64 years
Phase:
PHASE2
Brief Summary
This will be a multi-center, randomized, blinded, comparative, placebo-controlled, 4 arm crossover study in patients with primary insomnia.
Detailed Description
Prospective patients will spend 2 nights in the sleep lab for baseline PSG assessments. Those who meet the protocol inclusion/exclusion criteria will return for four treatment periods with two consecu...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00683436
Start Date
May 1 2008
End Date
November 1 2008
Last Update
July 22 2008
Active Locations (9)
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1
Broward Research Group
Pembroke Pines, Florida, United States, 33026
2
Miami Research Associates
South Miami, Florida, United States, 33143
3
Neurotrials Research, Inc
Atlanta, Georgia, United States, 30342
4
Sleep and Behavior Medicine Institute
Vernon Hills, Illinois, United States, 60061