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A Study With GW597599 And GR205171: Potential New Drugs For The Treatment Of Primary Insomnia | Clinical Trials | Clareo Health

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

Vestipitant and Vofopitant 2 Day PSG Study for Insomnia

NCT00606697•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+8 more criteria

Exclusion Criteria

•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.
+25 more criteria

Locations (10)

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, Germany

GSK Investigational Site

Dortmund, North Rhine-Westphalia, Germany

GSK Investigational Site

Münster, North Rhine-Westphalia, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Hamburg, Germany

GSK Investigational Site

Hamburg, Germany

GSK Investigational Site

Hamburg, Germany

Key Dates

Start Date

December 19, 2007

Primary Completion Date

May 7, 2008

Completion Date

May 7, 2008

Last Updated

July 11, 2017

Enrollment

ACTUAL participants

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

GR205171

DRUG

GW597599

DRUG

Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress

NCT03642028

Sleep Initiation and Maintenance DisordersStress Disorders, Posttraumatic

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RECRUITINGNA

Optimizing Sleep Health in Nurses

NCT05965609

Circadian Rhythm Sleep-Wake Disorders, Shift Work TypeSleep Initiation and Maintenance Disorders

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress

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