A Study With GW597599 And GR205171: Potential New Drugs For The Treatment Of Primary Insomnia

NCT00606697 | Completed Phase 2

• 1 other identifier: NKI110334
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 10

Brief Summary

Patients with Primary Insomnia will be treated with GW597599 and GR205171 to evaluate the efficacy in the sleep difficulties associated with insomnia

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Primary Insomnia Adults

Outcome Measures

Primary Outcomes (3)

• Total Sleep Time (TST) from PSG recording

  TST was defined as the total amount of time (measured in minutes) that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. The score was derived by a central polysomnography (PSG) reader and was analyzed as the mean of the PSG TST recordings obtained on two consecutive nights. If only one assessment was present for a particular PSG session, the score from that one assessment was used.

  Night 1 and Night 2 of every treatment period (Up to Day 63)

• Latency to Persistent Sleep (LPS) from PSG recording

  LPS was defined as the amount of time measured in minutes it takes to fall asleep as the point at which 10 minutes of uninterrupted sleep has begun as determined based on PSG objective assessments of sleep disturbance. PSG recording was performed. The score was derived by a central polysomnography reader and was analyzed as the mean of the PSG TST recordings obtained on two consecutive nights. If only one assessment was present for a particular PSG session, the score from that one assessment was used.

  Night 1 and Night 2 of every treatment period (Up to Day 63)

• Wake time after sleep onset (WASO1) from PSG recording

  WASO was the time in minutes scored as wake between the onset of persistent sleep and lights on, where the onset of persistent sleep was the beginning of the first continuous 20 epochs (10 minute) scored as non-wake. Mean values were calculated based on 2 treatment PSG nights. The score was derived by a central polysomnography reader and was analyzed as the mean of the PSG TST recordings obtained on two consecutive nights. If only one assessment was present for a particular PSG session, the score from that one assessment was used.

  Night 1 and Night 2 of every treatment period (Up to Day 63)

Secondary Outcomes (20)

• PSG measures of sleep continuity: wake during sleep (WDS)

  Night 1 and Night 2 of every treatment period (Up to Day 63)

• PSG measures of sleep continuity: wake after sleep (WAS)

  Night 1 and Night 2 of every treatment period (Up to Day 63)

• PSG measures of sleep continuity: number of awakenings after sleep onset 1

  Night 1 and Night 2 of every treatment period (Up to Day 63)

• PSG measures of sleep structure: Non-rapid eye movement (NREM) sleep time

  Night 1 and Night 2 of every treatment period (Up to Day 63)

• PSG measures of sleep structure: Slow-Wave Sleep (SWS) time (stage 3 and 4)

  Night 1 and Night 2 of every treatment period (Up to Day 63)

Study Arms (1)

Overall study

ACTIVE COMPARATOR

Male and female subjects, 18-64 years of age (inclusive), with a primary diagnosis of primary insomnia

Drug: GR205171; Drug: GW597599

Interventions

GR205171 DRUG

10 milligrams (mg)

Overall study

GW597599 DRUG

15 mg

Overall study

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The subject must be able to read and understand the informed consent form and provide written informed consent, indicating the subjects 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.
• Subject is a male or female outpatient, at least 18 years of age and \<65 years.
• Diagnosis of primary insomnia, as defined by Diagnostic and Statistical Manual of Mental Disorders-Text Revision (DSM-IV-TR) criteria 307.42. A complaint of difficulty initiating or maintaining sleep or of non-restorative sleep, which lasts for at least 3 months preceding screening along with 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 a general medical condition.
• The subjects self-reported sleep history includes at least three months of a usual TST of less than 6 hours, SOL of at least 30 minutes and at least 3 awakening per night in at least 3 nights per week.
• On two screening PSGs (on single-blinded placebo administration at each night):
• TST between 240 and 390 minutes inclusive on both nights.
• Mean LPS of 30 minutes or more, but not \< 20 minutes on either night.
• Mean WASO of 60 minutes or more, with neither night \< 45 minutes.
• Time in bed between 6.5 and 8.5 hours for at least 5 nights per week over the preceding 3 months
• Bed time between 21.00 and 24.00 hours that does not vary by more than ±2 hour preceding 3 months
• Women of childbearing potential must commit to consistent and correct use of an acceptable method of birth control; GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of a physician, are as follows:
• Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal. For purposes of this study, postmenopausal is defined as one year without menses)
• Child-bearing potential, has a negative serum pregnancy test result at screen and a negative urine dipstick pregnancy test at baseline (prior to study drug administration), and agrees to one of the following:
• Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject
• Oral contraceptives (either combined or progestogen only)

You may not qualify if:

• Any clinically significant psychiatric disorder other than primary insomnia as defined by DSM-IV-TR.
• \- Subject must not have a Beck Depression Inventory (version II) \[Beck, 1996\] total score of 29 or greater at the Screening Visit. Patients scoring 17 to 28 must be confirmed by a qualified clinician to not have major depressive illness to be eligible.
• Symptoms/signs that are consistent with any primary sleep disorder other than primary insomnia, e.g., sleep apnea, restless leg syndrome, circadian rhythm sleep disorder.
• 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.
• Positive urine drug screen (i.e., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates) or alcohol breath test at screening. No repeat test allowed.
• Any clinically significant unstable medical or surgical condition (treated or untreated).
• Any history of a clinically significant abnormality of the neurological system (including cognitive disorders or significant head injury) or any history of seizure (excluding febrile seizure).
• Subject has an unstable medical disorder; or a disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of GW597599 or GR205171; or interfere with the accurate assessment of safety or efficacy.
• Subjects having clinically significant abnormalities in haematology, blood chemistry, ECG, urinalysis, physical exam, vital signs, or other protocol-specified screening test which are not resolved by the baseline visit.
• Subjects with a history of clinically significant hepatic, cardiac (e.g. including myocardial infarction), renal, neurologic (e.g. including seizures), cerebrovascular, metabolic or pulmonary disease.
• Any serious medical disorder or condition that would in the Investigator's opinion, preclude the administration of study medication.
• Subjects who have any laboratory value outside the sponsor-specified ranges at the Screening Visit (See Appendix 9: Laboratory Parameters). Testing may be repeated once to see if value returns to within range, but such laboratory value must be resolved by the Screening PSG session (PSG 1/2).
• Subjects who are not euthyroid as evidenced by normal TSH. Subjects maintained on thyroid medication must be euthyroid for a period of at least six months prior to the Screening Visit, with no dose changes.
• Known seropositivity for human immunodeficiency virus (HIV).
• Chronic hepatitis B and C, as evidenced by positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (10)

GSK Investigational Site

Mannheim, Baden-Wurttemberg, 68159, Germany

Location

GSK Investigational Site

Munich, Bavaria, 80331, Germany

Location

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

GSK Investigational Site

Dortmund, North Rhine-Westphalia, 44263, Germany

Location

GSK Investigational Site

Münster, North Rhine-Westphalia, 48149, Germany

Location

GSK Investigational Site

Berlin, 10787, Germany

Location

GSK Investigational Site

Berlin, 13125, Germany

Location

GSK Investigational Site

Hamburg, 20246, Germany

Location

GSK Investigational Site

Hamburg, 20253, Germany

Location

GSK Investigational Site

Hamburg, 22769, Germany

Location

Related Publications (1)

• This study has not been published in the scientific literature.

  BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

vofopitant; vestipitant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 4, 2008
• Study Start: December 19, 2007
• Primary Completion: May 7, 2008
• Study Completion: May 7, 2008
• Last Updated: July 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

DE (10)