Efficacy and Safety Study of Adipiplon, Placebo and an Active Control in Primary Insomniacs

This study has been terminated.
Sponsor:
Information provided by:
Neurogen Corporation
ClinicalTrials.gov Identifier:
NCT00683436
First received: May 21, 2008
Last updated: July 21, 2008
Last verified: July 2008
  Purpose

This will be a multi-center, randomized, blinded, comparative, placebo-controlled, 4 arm crossover study in patients with primary insomnia.


Condition Intervention Phase
Primary Insomnia
Drug: Adipiplon
Drug: Placebo
Drug: Ambien CR
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Blinded, Active and Placebo-Controlled, Crossover Study of the Efficacy and Safety of Two Doses of Adipiplon Bilayer Tablets in Primary Insomniacs

Resource links provided by NLM:


Further study details as provided by Neurogen Corporation:

Primary Outcome Measures:
  • The study will involve PSG measurement of sleep onset and maintenance. [ Time Frame: two consecutive nights on each treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The study will involve subjective measures of sleep and next day function. [ Time Frame: two consecutive nights on each treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: May 2008
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
adipiplon 6 mg
Drug: Adipiplon
bilayer tablets 6 mg
Experimental: 2
adipiplon 9 mg
Drug: Adipiplon
bilayer tablets 9 mg
Placebo Comparator: 3
Placebo
Drug: Placebo
Placebo
Experimental: 4
Ambien CR 12.5 mg
Drug: Ambien CR
Ambien CR 12.5 mg

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 consecutive nights in each. Study medication will be administered in the sleep laboratory 30 minutes before the patient's usual bedtime.

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683436

Locations
United States, Florida
Broward Research Group
Pembroke Pines, Florida, United States, 33026
Miami Research Associates
South Miami, Florida, United States, 33143
United States, Georgia
Neurotrials Research, Inc
Atlanta, Georgia, United States, 30342
United States, Illinois
Sleep and Behavior Medicine Institute
Vernon Hills, Illinois, United States, 60061
United States, Kansas
Vince & Associates Clinical Research
Overland Park, Kansas, United States, 66212
United States, Missouri
St. Luke's Hospital Sleep Medicine and Research Center
Chesterfield, Missouri, United States, 63017
United States, New York
Clinilabs, Inc.
New York, New York, United States, 10019
United States, Ohio
Tri-State Sleep Disorders Center
Cincinnati, Ohio, United States, 45246
United States, Oklahoma
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
Sponsors and Collaborators
Neurogen Corporation
  More Information

No publications provided

Responsible Party: Study Manager, Neurogen Corporation
ClinicalTrials.gov Identifier: NCT00683436     History of Changes
Other Study ID Numbers: NG2-73-205
Study First Received: May 21, 2008
Last Updated: July 21, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Neurogen Corporation:
insomnia

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014