Primary Insomnia in Adult Outpatients MedDRA version: 9.1 Level: LLT Classification code 10036701 Term: Primary insomnia
Conditions
Interventions
Product Name: Vestipitant
Pharmaceutical Form: Tablet
Current Sponsor code: GW597599
Other descriptive name: Vestipitant
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration num
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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 40 MlU/ml and estradiol =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To compare the efficacy of oral vestipitant (15mg/day) with placebo after 4 weeks of nightly treatment in adult outpatients diagnosed with primary insomnia, as determined objectively by polysomnography (PSG). ;Secondary Objective: • To compare the efficacy of vestipitant with placebo over the first 2 days of treatment using PSG. • To evaluate maintenance of the hypnotic effect of vestipitant compared with placebo using a subject-completed Post-Sleep Questionnaire (PSQ) administered by an Interactive Voice Response System (IVRS). • To compare the efficacy of vestipitant with placebo after 4 weeks using the subject-completed Insomnia Severity Index (ISI). • To compare the effects of vestipitant with placebo over the first 2 days of treatment and after 4 weeks of treatment on sleep stage distribution, using PSG. • To compare the safety and tolerability of vestipitant with placebo. • To compare the effects of vestipitant with placebo over 4 weeks on motor and cognitive functioning in the morning. • To evaluate discontinuation symptoms and rebound insomnia using the Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ), and PSQ, respectively, following 4 weeks of treatment.;Primary end point(s): Wake after sleep onset (WASO) as the mean of PSG recordings obtained on two consecutive nights on Days 27/28. | — |
Countries
Germany
Outcome results
None listed