A 28-Day, Polysomnographic and Subjective Assessment of Vestipitant (15mg/day) for the Treatment of Primary Insomnia in Adult Outpatients.

• Conditions: Primary Insomnia in Adult Outpatients; MedDRA version: 9.1Level: LLTClassification code 10036701Term: Primary insomnia

• Registration Number: EUCTR2008-006345-72-DE
• Lead Sponsor: GlaxoSmithKline Research & Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-17
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

1. The subject must be able to read and understand the informed consent form and provide written informed consent, indicating the subject’s understanding of the purpose of the study and willingness to comply with all study procedures described in the protocol, including all sleep-laboratory restrictions and procedures.
2. Male and female subjects 18 through 64 years of age (inclusive).
3. Diagnosis of Primary Insomnia, based on Diagnostic and Statistical Manual of Mental Disorders –Text Revision (DSM-IV-TR) criteria 307.42.
• A complaint of difficulty initiating and maintaining sleep or of non-restorative sleep three or more times per week, for at least the 3 months preceding screening.
• The sleep disturbance causes clinically significant distress or impairment in social, occupational, or other important areas of functioning.
• The disturbance in sleep does not occur exclusively during the course of another sleep disorder or occur exclusively during the course of another mental disorder.
• Lastly, the disturbance is not due to the direct physiological effects of a substance or general medical condition, such as lung disease, cerebrovascular disease, systemic infectious disease, cancer, chronic pain conditions (e.g. arthritis), endocrine conditions, and degenerative neurological disorders.
4. The subject’s self-reported sleep history includes at least three months of a usual (i.e. > 3 nights per week) TST of less than 6.0 hours, a sleep onset latency (SOL) of at least 30 minutes and WASO => 60 minutes.
5. Time in bed between 6.5 and 8.5 hours for least 5 nights per week over the preceding 3 months.
6. Bed time between 21.00 and 24.00 hours that does not vary by more than +/- 2 hours over the preceding 3 months. Bedtime (lights out) will be confirmed by a one-week diary completed before the first PSG screening session (Visits 2/3).
7. The sleep variables obtained from the two screening PSG sessions (with single-blinded placebo administration at each night) must fall within the following ranges:
• TST between 240 and 420 minutes inclusive on both nights
• Mean LPS of 20 minutes or more, and LPS not < 15 minutes on either night
• Mean WASO of 60 minutes or more, and WASO not < 45 minutes on either night
8. A female subject is eligible to participate if she is of:
• Non-childbearing potential defined as pre-menopausal females with a
documented tubal ligation or hysterectomy; or postmenopausal defined as 12
months of spontaneous amenorrhea [in questionable cases a blood sample with
simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol <
40 pg/ml (<140 pmol/L) is confirmatory].
• Child-bearing potential and agrees to use one of the contraception methods
listed in Section 4.5 in the protocol for an appropriate period of time (as determined by the
product label or investigator) prior to the start of dosing to sufficiently minimize
the risk of pregnancy at that point. Female subjects must agree to use
contraception until 3 days post-last dose.
9. The subject is in good health as determined by medical and psychiatric history,
physical examination, ECG, and serum chemistry, hematology, serology, and
urinanalysis results.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects meeting any of the following criteria must not be enrolled in the study:
1. Symptoms/signs that are consistent with any primary sleep disorder other than primary insomnia, e.g. sleep apnea, restless leg syndrome, circadian rhythm disorder.
2. Any clinically significant Axis I psychiatric disorder other than primary insomnia as defined by DSM-IV-TR.
3. Subject has a recent history (12 months) of mood or other mental disorders that the investigator regards as accounting for the insomnia.
4. Subject has a Beck Depression Inventory (Version II) [Beck, 1996] total score of 29 or greater at the Screening Visit (Visit 1) or at Visit 4 (if 2 weeks have elapsed between screening visit and randomization). Patients scoring 17 to 28 must be confirmed to not have major depressive illness to be eligible.
5. History of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence (with the exception of tobacco use) within the past 12 months as defined by DSM-IV-TR.
6. Positive urine drug screen (i.e. amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates) at Screening Visit (Visit 1). A repeat test will not be allowed if the result is positive.
7. Positive alcohol breath test at Screening Visit (Visit 1), i.e. alcohol level greater than 0.015% after subject being told that they must not drink for 8 hours preceding the Screening Visit (Visit 1). A repeat test will not be allowed if the result is positive.
8. Any history of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (except febrile seizure).
9. Subjects with an unstable medical disorder or a disorder that would likely interfere with the action, absorption, distribution, metabolism or excretion of vestipitant, may pose a safety concern, or interfere with accurate assessment of efficacy or safety.
10. Subjects have any screening electrocardiography (ECG) parameter outside of the Sponsor-specified ranges as determined by a central ECG reader (See Appendix 2: ECG Parameters); the ECG may be repeated once to see if the parameter returns to within range but any such abnormality must be resolved by the first screening PSG session (Visit 2).
11. Subjects have any ECG finding that in the Investigator’s judgement is considered to be clinically significant and not resolved by the first day of screening PSG session (Visit 2) (even if not outside of Sponsor-specified ranges in Appendix 2: ECG Parameters).
12. Known seropositivity for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
13. Women having a positive serum HCG pregnancy test at the Screening Visit (Visit 1), a positive urine pregnancy dipstick during the screening PSG session (Visit 2) or at Visit 4 (Randomization), or who are lactating or planning to become pregnant within 14 weeks following the Screening Visit (Visit 1).
14. Subjects have any screening laboratory value outside of the Sponsor-specified ranges at the Screening Visit (Visit 1) (See Appendix 3: Laboratory Parameters). Testing may be repeated once to see if value returns to within range but any such laboratory abnormality must be resolved by the screening PSG session (Visit 2).
15. Subjects have any laboratory abnormality that in the Investigator’s judgement is considered to be clinically significant and not resolved by the first day of the screening PSG session (Visit 2) (even if not outside of Sponsor-spec

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified