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    The EU Clinical Trials Register currently displays   44157   clinical trials with a EudraCT protocol, of which   7327   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-004035-35
    Sponsor's Protocol Code Number:NKI1103334
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-09-19
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2007-004035-35
    A.3Full title of the trial
    A multi-centre, randomized, double-blind, placebo-controlled, cross-over study to evaluate the effects of GW597599 and GR205171 on sleep continuity, PSG sleep recordings, subjective sleep assessment and daytime cognitive function in subjects with primary insomnia
    A.4.1Sponsor's protocol code numberNKI1103334
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research & Devleopment Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGW597599
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeGW597599
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGR205171
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeGR205171
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary insomnia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10036701
    E.1.2Term Primary insomnia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the acute effects of GW597599 15 mg on sleep in adults with Primary Insomnia as determined objectively by polysomnography (PSG).
    • To evaluate the acute effects of GR205171 10 mg on sleep in adults with Primary Insomnia as determined objectively by PSG.
    E.2.2Secondary objectives of the trial
    • To investigate the effects of GW597599 and GR205171 on subjective sleep parameters and sleep quality using the self reported Post-Sleep Questionnaire.
    • To evaluate the difference between GW597599 and GR205171 in the acute effects on sleep in adults with Primary Insomnia as determined objectively by PSG.
    • To investigate the effects of GW597599 and GR205171 on daytime cognitive functioning on the morning following dosing, including tests of alertness, memory, attention and fine motor control.
    • To investigate the safety and the pharmacokinetic (PK) profile of GW597599 and GR205171 in subjects with primary insomnia after 2 consecutive days of oral administration.
    • To investigate the relationship between plasma concentrations of GW597599 and GR205171 and sleep or cognitive parameters, and to develop a PK/PD model.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in this study only if all of the following criteria apply:
    1. 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.
    2. Subject is a male or female outpatient, at least 18 years of age and <65 years.
    3. 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.
    4. 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.
    5. 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.
    6. Time in bed between 6.5 and 8.5 hours for at least 5 nights per week over the preceding 3 months
    7. Bed time between 21.00 and 24.00 hours that does not vary by more than ±2 hour preceding 3 months
    8. 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)
    • Double-barrier method of contraception consisting of spermicide with either condom or diaphragm
    • IUD with a documented failure rate of less than 1% per year
    • Complete abstinence from intercourse for two weeks before exposure to the investigational product, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of three days, equivalent to five half lives)
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria apply:
    1. Any clinically significant psychiatric disorder other than primary insomnia as defined by DSM-IV-TR.
    • Subject must not have a Beck Depression Inventory total score of 29 or greater at the Screening Visit, view protocol.
    2. Symptoms/signs that are consistent with any primary sleep disorder other than primary insomnia, view protocol.
    3. History of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence within the past 12 months as defined by DSM-IV-TR (view protocol).
    4. Positive urine drug screen or alcohol breath test at screening. No repeat test allowed, (view protocol).
    5. Any clinically significant unstable medical or surgical condition (treated or untreated).
    6. Any history of a clinically significant abnormality of the neurological system or any history of seizure (view protocol).
    7. 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.
    8. 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.
    9. Subjects with a history of clinically significant hepatic, cardiac, renal, neurologic cerebrovascular, metabolic or pulmonary disease, view protocol.
    10. Any serious medical disorder or condition that would in the Investigator's opinion, preclude the administration of study medication.
    11. Subjects who have any laboratory value outside the sponsor-specified ranges at the Screening Visit, view protocol.
    12. Subjects who are not euthyroid as evidenced by normal TSH, view protocol.
    13. Known seropositivity for human immunodeficiency virus (HIV).
    14. Chronic hepatitis B and C, as evidenced by positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody.
    15. Subjects who have any electrocardiogram (ECG) parameter outside of the Sponsor-specified range. The ECG maybe repeated once to see if the parameter returns to within range, but any such abnormality must be resolved by the screening PSG session (Visits 2/3, view protocol).
    16. Apnea-hypopnea index of 10 or more/hour of sleep on screening PSG Night 1. Subjects failing this criterion on Night 1 Screening PSG should not be screened on Night 2.
    17. Movement arousal index of 10 or more/hour of sleep on screening PSG Night 1. Subjects failing this criterion on Night 1 Screening PSG should not be screened on Night 2.
    18. Body mass index of 34 or more at Screening Visit.
    19. Nightshift or rotating-shift work within the last 2 work weeks or during the study period.
    20. Planned travel across more than 2 time zones during the study or in the 2 weeks prior to screening.
    21. Consumption of 300 mg or more per day on average of xanthine-containing beverages over the preceding 1 month [view protocol].
    22. Smoking more than 1 pack of cigarettes per day (20 cigarettes) on average over the preceding 1 month, or inability to stop smoking during the study.
    23. Typical consumption of more than 7 (women) or 14 (men) alcoholic units in any week, or more than 2 (women) or 3 (men) alcoholic units in any single day, over the preceding 1 month [view protocol].
    24. Regular intentional napping, i.e., more than 2 naps per week
    25. Use of any psychotropic medications or other medications prior to screening or need to use any of these medications at any time during the study, view protocol.
    26. Any history of depot neuroleptic use
    27. All other (non-psychotropic) drugs metabolised via the P450 3A4 pathway and CYP3A4 inducers/inhibitors must be discontinued, view protocol.
    28. Subjects (i.e. asthmatics) who have used systemic corticosteroids within 1 week or 5 half-lives (whichever is longer) prior to the screening visit.
    29. Participation in investigational trial involving NK1 antagonist (including GW679769) in the past or use of any investigational drug, view protocol.
    30. Subjects who have had hypersensitivity or intolerance to NK1 antagonists including GW597599 and GR205171.
    31. Subjects who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures.
    32. Women having a positive serum HCG pregnancy test at Screening Visit, view protocol.
    33. An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women from the time of the first dose of study medication until 90 days following administration of the last dose of study medication.
    34. An unwillingness of the male subject to use a condom/spermicide in addition to having their female partner use another form of contraception, view protocol.
    E.5 End points
    E.5.1Primary end point(s)
    • Total Sleep Time (TST), Latency to Persistent Sleep (LPS) and Wake time after sleep onset (WASO) derived from PSG recording.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 48
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    As both GW597599 & GR205171 are not licensed compounds no after care treatment will be provided after the trial ends. However, standard medical care will be provided thoughout the trial
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-05-07
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