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Primary InsomniaPhase 2NCT00683436

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

A Phase 2 study testing Adipiplon and Ambien CR in people with Primary Insomnia, run by Neurogen Corporation at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 21 to 64 years
Conditions the study is for
Primary Insomnia
What is being tested?
Adipiplon and Ambien CR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
9 sitesUnited States
Study dates
May 2008to Nov 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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).

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Neurotrials Research, Inc

    Atlanta, Georgia, 30342

  • St. Luke's Hospital Sleep Medicine and Research Center

    Chesterfield, Missouri, 63017

  • Tri-State Sleep Disorders Center

    Cincinnati, Ohio, 45246

  • Clinilabs, Inc.

    New York, New York, 10019

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Vince & Associates Clinical Research

    Overland Park, Kansas, 66212

  • Broward Research Group

    Pembroke Pines, Florida, 33026

  • Miami Research Associates

    South Miami, Florida, 33143

  • Sleep and Behavior Medicine Institute

    Vernon Hills, Illinois, 60061

Other trials in United States

About this study

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

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

Read the 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.

Being tested
Adipiplon, Placebo, Ambien CR
Keywords
insomnia
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdipiplonDrug

    bilayer tablets 6 mg

  • PlaceboDrug

    Placebo

  • Ambien CRDrug

    Ambien CR 12.5 mg

  • AdipiplonDrug

    bilayer tablets 9 mg

Study groups in NCT00683436
Study groupRoleWhat they receive
1Experimentaladipiplon 6 mg
Receives: Drug: Adipiplon
2Experimentaladipiplon 9 mg
Receives: Drug: Adipiplon
3Placebo comparatorPlacebo
Receives: Drug: Placebo
4ExperimentalAmbien CR 12.5 mg
Receives: Drug: Ambien CR

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: two consecutive nights on each treatment

Secondary outcomes (1)

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

    Measured: two consecutive nights on each treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionOct 2008 (estimated)
  4. Study completionNov 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00683436
Sponsor's protocol ID
NG2-73-205
Status last verified
Jul 2008
First submitted
21 May 2008
Last updated
22 Jul 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adipiplon and Ambien CR in people with Primary Insomnia, run by Neurogen Corporation at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The study will involve PSG measurement of sleep onset and maintenance. (time frame: two consecutive nights on each treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00683436.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2008.

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