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

NCT00683436 | Terminated Phase 2

• 1 other identifier: NG2-73-205
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Primary Insomnia

Keywords

insomnia

Outcome Measures

Primary Outcomes (1)

• The study will involve PSG measurement of sleep onset and maintenance.

  two consecutive nights on each treatment

Secondary Outcomes (1)

• The study will involve subjective measures of sleep and next day function.

  two consecutive nights on each treatment

Study Arms (4)

1

EXPERIMENTAL

adipiplon 6 mg

Drug: Adipiplon

2

EXPERIMENTAL

adipiplon 9 mg

Drug: Adipiplon

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

4

EXPERIMENTAL

Ambien CR 12.5 mg

Drug: Ambien CR

Interventions

Adipiplon DRUG

bilayer tablets 6 mg

1

Placebo DRUG

Placebo

3

Ambien CR DRUG

Ambien CR 12.5 mg

4

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Neurogen Corporation: lead

Study Sites (9)

Broward Research Group

Pembroke Pines, Florida, 33026, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Neurotrials Research, Inc

Atlanta, Georgia, 30342, United States

Location

Sleep and Behavior Medicine Institute

Vernon Hills, Illinois, 60061, United States

Location

Vince & Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

St. Luke's Hospital Sleep Medicine and Research Center

Chesterfield, Missouri, 63017, United States

Location

Clinilabs, Inc.

New York, New York, 10019, United States

Location

Tri-State Sleep Disorders Center

Cincinnati, Ohio, 45246, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

adipiplon; Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: November 1, 2008
• Last Updated: July 22, 2008

Record last verified: 2008-07

Locations

US (9)