Able to Read/Understand/Provide Informed Consent and Protocol Compliance
Item
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 sleeplaboratory restrictions and procedures.
boolean
C0586740 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0162340 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3])
C0525058 (UMLS CUI [4])
Gender and Age
Item
Male and female subjects 18 through 64 years of age (inclusive).
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Primary Insomnia diagnosis by DSM-IV
Item
Diagnosis of Primary Insomnia, based on Diagnostic and Statistical Manual of Mental Disorders Text Revision (DSM-IV-TR) criteria 307.42
boolean
C0033139 (UMLS CUI [1])
C0220952 (UMLS CUI [2])
Self-reported history of sleep problems, by total sleep time, sleep onset latency, and wake after sleep onset
Item
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.
boolean
C2700446 (UMLS CUI [1,1])
C3539544 (UMLS CUI [1,2])
C4722414 (UMLS CUI [2])
C4505222 (UMLS CUI [3])
C4744894 (UMLS CUI [4])
Time spent in bed
Item
Time in bed between 6.5 and 8.5 hours for least 5 nights per week over the preceding 3 months.
boolean
C2135946 (UMLS CUI [1])
Constant Bedtime, confirmed by diary
Item
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).
boolean
C4053890 (UMLS CUI [1,1])
C1948059 (UMLS CUI [1,2])
C3890583 (UMLS CUI [2])
Polysomnography results: Total sleep time, sleep latency, wake after sleep onset
Item
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
boolean
C0162701 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C4722414 (UMLS CUI [2])
C0430629 (UMLS CUI [3])
C4744894 (UMLS CUI [4])
Child Bearing Potential and Contraception
Item
A female subject is eligible to participate if she is of: - Non-childbearing potential - Child-bearing potential and agrees to use one of the contraception methods listed in Section 4.5 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.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Health Status by medical and psychiatric history, physical examination, ECG, and serum chemistry, hematology, serology, and urinalysis
Item
The subject is in good health as determined by medical and psychiatric history, physical examination, ECG, and serum chemistry, hematology, serology, and urinalysis results.
boolean
C0018759 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0748059 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
C1623258 (UMLS CUI [5])
C1883010 (UMLS CUI [6])
C0474523 (UMLS CUI [7])
C0036743 (UMLS CUI [8])
C0042014 (UMLS CUI [9])
Symptoms of sleep disorder other than primary insomnia, e.g. sleep apnea, restless leg syndrome, circadian rhythm disorder
Item
Symptoms/signs that are consistent with any primary sleep disorder other than primary insomnia, e.g. sleep apnea, restless leg syndrome, circadian rhythm disorder.
boolean
C0037088 (UMLS CUI [1,1])
C0851578 (UMLS CUI [1,2])
C0033139 (UMLS CUI [1,3])
C0332300 (UMLS CUI [1,4])
C0037315 (UMLS CUI [2])
C0035258 (UMLS CUI [3])
C0813142 (UMLS CUI [4])
Significant Psychiatric Axis I except primary insomnia (by DSM-IV)
Item
Any clinically significant Axis I psychiatric disorder other than primary insomnia as defined by DSM-IV-TR.
boolean
C0270287 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0033139 (UMLS CUI [1,4])
C0332300 (UMLS CUI [1,5])
C0220952 (UMLS CUI [2])
Recent mood or mental disorder causing insomnia by investigator judgement
Item
Subject has a recent history (12 months) of mood or other mental disorders that the investigator regards as accounting for the insomnia.
boolean
C0525045 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0917801 (UMLS CUI [1,4])
C0022423 (UMLS CUI [1,5])
C0008961 (UMLS CUI [1,6])
C0205394 (UMLS CUI [2,1])
C0004936 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C0566251 (UMLS CUI [2,4])
C0917801 (UMLS CUI [2,5])
C0022423 (UMLS CUI [2,6])
C0008961 (UMLS CUI [2,7])
Beck Depression Inventory Score
Item
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).
boolean
C2960571 (UMLS CUI [1])
Recent Alcohol, Narcotic, Benzodiazepine or other Substance Abuse except tobacco use (by DSM-IV criteria)
Item
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.
boolean
C0332185 (UMLS CUI [1,1])
C0085762 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0524661 (UMLS CUI [2,2])
C0332185 (UMLS CUI [3,1])
C0338768 (UMLS CUI [3,2])
C0332185 (UMLS CUI [4,1])
C0205394 (UMLS CUI [4,2])
C0038580 (UMLS CUI [4,3])
C1705847 (UMLS CUI [4,4])
C0543414 (UMLS CUI [4,5])
C0220952 (UMLS CUI [5])
Positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates)
Item
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.
boolean
C0743300 (UMLS CUI [1])
C0002667 (UMLS CUI [2])
C0004745 (UMLS CUI [3])
C0005064 (UMLS CUI [4])
C0006864 (UMLS CUI [5])
C0009170 (UMLS CUI [6])
C0376196 (UMLS CUI [7])
Positive Alcohol Breath Test
Item
Positive alcohol breath test at Screening Visit (Visit l), 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 I). A repeat test will not be allowed if the result is positive.
boolean
C1112499 (UMLS CUI [1])
History of neurological disorder (incl. dementia, cognitive disorder, significant head injury) or seizures (except febrile seizures)
Item
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).
boolean
C0262926 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0497327 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0009241 (UMLS CUI [3,2])
C0262926 (UMLS CUI [4,1])
C0018674 (UMLS CUI [4,2])
C1546944 (UMLS CUI [4,3])
C0262926 (UMLS CUI [5,1])
C0036572 (UMLS CUI [5,2])
C1705847 (UMLS CUI [5,3])
C0009952 (UMLS CUI [5,4])
Unstable Medical Disorder or disorder interfering pharmacodynamics/pharmacokinetics of vestipitant, safety or evaluation
Item
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.
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2607417 (UMLS CUI [2,3])
C0243145 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2607417 (UMLS CUI [3,3])
C0031328 (UMLS CUI [3,4])
C0012634 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0036043 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0220825 (UMLS CUI [5,3])
ECG Abnormalities by Sponsor criteria
Item
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).
boolean
C0522055 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
ECG Abnormalities by Investigator Judgement
Item
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).
boolean
C0522055 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
HIV, Hepatitis B or Hepatitis C
Item
Known seropositivity for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Positive serum/urine pregnancy test, lactating or planning to become pregnant
Item
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).
boolean
C0430059 (UMLS CUI [1])
C0430063 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
Laboratory Tests Abnormal by Sponsor criteria
Item
Subjects have any screening laboratory value outside of the Sponsorspecified 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).
boolean
C0438215 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
Laboratory Results Abnormal by Investigator Judgement
Item
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-specified ranges in Appendix 3: Laboratory Parameters).
boolean
C0438215 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
Abnormal thyroid function
Item
Subjects who are not euthyroid based on laboratory tests at the screening visit. Subjects maintained on thyroid medication must be euthyroid for a period of at least 6 months prior to the Screening Visit (Visit 1), with no dose changes.
boolean
C0476414 (UMLS CUI [1])
BMI
Item
Body mass index of 34 or more at the Screening Visit (Visit 1).
boolean
C1305855 (UMLS CUI [1])
Apnea-hypopnea Index
Item
Apnea-hypopnea index of 10 or more on Night 1 screening PSG (Visit 2). Subjects failing Night I screening PSG should not be screened on Night 2 (Visit 3).
boolean
C2111846 (UMLS CUI [1])
Periodic Limb Movements with Arousal
Item
Periodic limb movements with arousal of 10 or more/hour of sleep on Night 1 screening PSG (Visit 2). Subjects failing Night 1 screening PSG should not be screened on Night 2 (Visit 3).
boolean
C1561887 (UMLS CUI [1,1])
C0003808 (UMLS CUI [1,2])
Recent or current nightshift or rotating shifts
Item
Nightshift or rotating shift-work within 1 month preceding the Screening Visit (Visit 1) or during the study period.
boolean
C0332185 (UMLS CUI [1,1])
C4505094 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C4505093 (UMLS CUI [2,2])
C0521116 (UMLS CUI [3,1])
C4505094 (UMLS CUI [3,2])
C0521116 (UMLS CUI [4,1])
C4505093 (UMLS CUI [4,2])
Recent or planned travel across time zones
Item
Planned travel across more than 3 time zones during the study or in the 2 weeks preceding the Screening Visit (Visit 1).
boolean
C1301732 (UMLS CUI [1,1])
C2825194 (UMLS CUI [1,2])
C0040802 (UMLS CUI [1,3])
C0040802 (UMLS CUI [2,1])
C2825194 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
Regular Napping
Item
Regular napping, i.e. more than 2 naps per week.
boolean
C0870935 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Caffeine or Xanthine Consumption
Item
Consumption of beverages or foods containing a total of 300 mg or more per day on average of caffeine or other xanthines ( e.g. coffee, cola, tea, chocolate) over the one month preceding the Screening Visit (Visit 1)
boolean
C0948365 (UMLS CUI [1])
C0043314 (UMLS CUI [2,1])
C1512806 (UMLS CUI [2,2])
Smoking Status or Nighttime smoking
Item
Smoking more than 1 pack of cigarettes (20) per day on average over the one month preceding the Screening Visit (Visit 1), or routinely a smoker during the night.
boolean
C1519386 (UMLS CUI [1])
C0037369 (UMLS CUI [2,1])
C0240526 (UMLS CUI [2,2])
Alcohol Consumption
Item
Typical consumption of more than 14 alcoholic units in any week, or more than 3 alcoholic units in any single day, over the one month preceding the Screening Visit (Visit 1)
boolean
C0001948 (UMLS CUI [1])
Use of Psychotropic Medications, e.g. benzodiazepines, anxiolytics, barbiturates, narcotics, or others incl. OTC drugs affecting sleep/wake function
Item
Use of any psychotropic medications, such as benzodiazepines and other anxiolytics, barbiturates, and narcotics, or other medications, including over-the-counter (OTC) products, that may affect sleep/wake function within 1 week or 5 half-lives (whichever is longer) prior to the Screening Visit (Visit 1) or need to use any of these medications at any time during the study.
boolean
C0033978 (UMLS CUI [1])
C0005064 (UMLS CUI [2])
C0040616 (UMLS CUI [3])
C0004745 (UMLS CUI [4])
C0027415 (UMLS CUI [5])
C0013227 (UMLS CUI [6,1])
C0205394 (UMLS CUI [6,2])
C0521102 (UMLS CUI [6,3])
C4062291 (UMLS CUI [6,4])
C2709201 (UMLS CUI [7,1])
C0013227 (UMLS CUI [7,2])
C0521102 (UMLS CUI [7,3])
C4062291 (UMLS CUI [7,4])
Recently started Cognitive Behavioral Therapy
Item
Cognitive Behavioral Therapy started within 1 month prior to the screening vis it ( i.e. within one month of Visit 1).
boolean
C0332185 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0009244 (UMLS CUI [1,3])
Chronic Systemic Corticosteroids, except inhaled corticosteroids in controlled asthma
Item
Has received chronic therapy with systemic corticosteroids within 12 months prior to the Screening Visit (Visit 1). Asthmatic subjects using an inhaled corticosteroid as part of their regular maintenance therapy are eligible provided their asthma is under control (especially as night).
boolean
C0205191 (UMLS CUI [1,1])
C4053960 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C2911690 (UMLS CUI [2,2])
C0004096 (UMLS CUI [2,3])
C2065041 (UMLS CUI [2,4])
Depot Neuroleptic Use
Item
Any history of depot neuroleptic use.
boolean
C2585377 (UMLS CUI [1])
Drugs (incl. OTC drugs and herbal products) metabolized by CYP3A4 or CYP3A4 inducers/inhibitors
Item
All other drugs metabolized via the P450 3A4 pathway and CYP3A4 inducers/inhibitors, including over-the-counter (OTC) and herbal products, must be discontinued from screening and are not allowed for the duration of the study (See Appendix 4).
boolean
C0013227 (UMLS CUI [1,1])
C1142644 (UMLS CUI [1,2])
C1524026 (UMLS CUI [1,3])
C1142644 (UMLS CUI [2,1])
C1524026 (UMLS CUI [2,2])
C0025125 (UMLS CUI [3,1])
C1142644 (UMLS CUI [3,2])
C1524026 (UMLS CUI [3,3])
C3830624 (UMLS CUI [4])
C3830625 (UMLS CUI [5])
Allergic Reaction or significant Adverse Effects to Vestipant or similar compounds
Item
Subjects who have a history of allergic reaction to, or significant adverse effects from vestipitant or closely related compounds.
boolean
C1527304 (UMLS CUI [1,1])
C2607417 (UMLS CUI [1,2])
C0750502 (UMLS CUI [2,1])
C0559546 (UMLS CUI [2,2])
C2607417 (UMLS CUI [2,3])
C1527304 (UMLS CUI [3,1])
C2607417 (UMLS CUI [3,2])
C2348205 (UMLS CUI [3,3])
C0750502 (UMLS CUI [4,1])
C0559546 (UMLS CUI [4,2])
C2607417 (UMLS CUI [4,3])
C2348205 (UMLS CUI [4,4])
Hypersensitivity to NK1 Antagonists
Item
Subjects who have had hypersensitivity or intolerance to NK1 antagonists.
boolean
C0020517 (UMLS CUI [1,1])
C3543440 (UMLS CUI [1,2])
Drug or Device Trial Participation Status
Item
Subjects who are currently participating in a clinical trial in which the subject is or will be exposed to an investigational or noninvestigational drug or device, or have done so within the preceding 3 months.
boolean
C2348568 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C0025080 (UMLS CUI [2,2])
Noncompliance expected in investigator's opinion
Item
Subjects who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures.
boolean
C0376405 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
C0008961 (UMLS CUI [1,4])