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Sleep Laboratory Study to Investigate the Safety and Efficacy of Neu-P11 in Primary Insomnia Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neurim Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT01489969
First received: December 6, 2011
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

This is a phase II study. It is conducted using a randomized, double-blind, 3-arm placebo controlled, parallel group design. Eligible patients will be randomized in a 1:1:1 ratio to receive Neu-P11 20 mg, Neu-P11 50 mg or placebo for 4 weeks The objective of this study is to assess the efficacy of Neu-P11 (20 and 50mg) on sleep continuity parameters in insomnia patients aged 18-80 years, following the first two nights (immediate effect) and at the end of 4 weeks of double-blind treatment. The primary efficacy endpoint in this study is Latency to Persistent Sleep (LPS) measured by polysomnogram (PSG) at the first two nights of treatment (nights 15-16 of the study; mean of two consecutive nights recordings). The secondary endpoints are number of awakenings after sleep onset and the duration of wake after sleep onset measured by PSG at the first two nights of treatment (nights 15-16 of the study; mean of two consecutive nights recordings).


Condition Intervention Phase
Primary Insomnia
Drug: Neu-P11
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Parallel Group, Randomized, Placebo Controlled Sleep Laboratory Study of Efficacy and Safety of Neu-P11 in Insomnia Patients Aged 18-80

Further study details as provided by Neurim Pharmaceuticals Ltd.:

Primary Outcome Measures:
  • Latency to persistent sleep [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    The primary efficacy parameter is LPS measured by the PSG at the first two nights (immediate effect) of the double blind treatment period.


Secondary Outcome Measures:
  • duration of wake after sleep onset (WASO) [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    The secondary efficacy parameter is the duration of wake after sleep onset (WASO) measured by the PSG at the first two nights (immediate effect) of the double blind treatment period

  • Number of awakenings (NOA) [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    The secondary efficacy parameter is number of awakenings (NOA) measured by the PSG at the first two nights (immediate effect) of the double blind treatment period


Enrollment: 137
Study Start Date: December 2011
Study Completion Date: January 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 20 mg
Neu-P11 dose of 20 mg
Drug: Neu-P11
1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Other Name: Melatonin agonist
Active Comparator: 50 mg
Neu-P11 dose of 50 mg
Drug: Neu-P11
1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Other Name: Melatonin agonist
Placebo Comparator: placebo
matching placebo
Drug: Neu-P11
1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Other Name: Melatonin agonist

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female and aged 18-80 years (both ages included).
  2. Suffering from primary insomnia according to DSM-IV criteria (307.42 primary insomnia, Appendix 25.1) (based on a Sleep History Questionnaire (SHQ) that is given to the patient at Visit Day 0, Appendix 25.1).
  3. Reported subjective sleep latency of at least 30 minutes on at least three nights per week for at least one month and subjective WASO of at least 45 minutes per night on at least 3 nights per week for at least one month (based on the SHQ).
  4. Subjects with habitual bed time within the range of 21:00-01:00 (inclusive), as reported by the subject during screening on Day 0.
  5. If female of childbearing potential, using a reliable method of contraception during the entire study duration and for at least 3 months after study drug intake.
  6. Have not been using benzodiazepine (BZD) and non-BZD hypnotics or melatoninergic drugs for the past 2 weeks or more prior to Screening.
  7. Have not been using psychotropic treatments for the past 3 months or more prior to Screening.
  8. Are stabilized on non-psychotropic treatments for more than 3 months prior to Screening.
  9. Are willing to sign a written informed consent to participate in the study.

    • After initial screening, recruited patients will enter a 2 week placebo baseline/eligibility period.

    Patients will be admitted into a sleep lab and will continue to the double blind treatment phase if polysomnography (PSG) results meet the following criteria:

  10. Mean LPS ≥30 minutes on both PSG screening nights, with neither night <15 minutes.
  11. Mean total sleep time (TST) ≤390 minutes, or mean WASO ≥30 minutes on both of the 2 PSG screening nights, with neither night <15 minutes.

Exclusion Criteria:

  1. According to DSM IV, subjects belonging to the following groups are excluded: 780.59 (breathing related sleep disorder); 307.45 (circadian rhythm sleep disorder); 307.47 (dyssomnia not otherwise specified); 780.xx (sleep disorder due to general medical condition)
  2. Subjects suffering from insomnia secondary to other causes according to the sleep history questionnaire.
  3. Subjects with sleep disorders detected during PSG inclusion/habituation night, such as sleep apnea/hypopnea and periodic leg movement syndrome (with arousal) (PLMAI>10 and/or AHI > 10 per hour).
  4. Use of psychotropic treatments for the past 3 months and during the study.
  5. Use of strong CYP inhibitors in the preceding 3 months and during the study
  6. Use of benzodiazepines or other hypnotics during preceding two weeks (including all benzodiazepines; zopiclone, zolpidem, zaleplon, barbiturates, buspirone and hydroxyzine).
  7. Alcohol intake - no more than 2 alcoholic drinks per day and any consumption less than 2 hours before study drug intake.
  8. Immunosuppressive medication in the preceding 3 months and during the study
  9. Severe neurological, psychiatric disorders especially psychosis, anxiety and depression
  10. Intercurrent acute or chronic somatic diseases likely to interact with sleep (for example: chronic pain from any etiology, benign prostatic hypertrophy likely to require surgery in the coming six months)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489969

Locations
United States, California
Pacific Research Network
San Diego, California, United States, 92103
United States, Florida
MD Clinical
Hallandale Beach, Florida, United States, 33009
Miami research Associates
South Miami, Florida, United States, 33143
United States, Georgia
Sleep Disorders Centers of Georgia
Atlanta, Georgia, United States, 30342
United States, Illinois
Chicago Research Center
Chicago, Illinois, United States, 60634
United States, Kansas
Vince & Associates Clinical Research
Overland Park, Kansas, United States, 66212
United States, Kentucky
Community Research and Sleep Management
Crestview Hills, Kentucky, United States, 41017
United States, Maryland
Center for Sleep and Wake Disorders
Chevy Chase, Maryland, United States, 20815
United States, New York
Clinilabs, Inc.
New York, New York, United States, 10119
Sponsors and Collaborators
Neurim Pharmaceuticals Ltd.
  More Information

No publications provided

Responsible Party: Neurim Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01489969     History of Changes
Other Study ID Numbers: Neu-P11-03-PSG
Study First Received: December 6, 2011
Last Updated: July 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Neurim Pharmaceuticals Ltd.:
sleep latency
Sleep maintenance
Sleep fragmentation
Polysomnography

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Dyssomnias
Mental Disorders
Nervous System Diseases
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 20, 2014