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    Summary
    EudraCT Number:2007-005194-56
    Sponsor's Protocol Code Number:AC-057A301
    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:2008-06-09
    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 number2007-005194-56
    A.3Full title of the trial
    Multi center, double blind, randomized, placebo controlled, active reference, parallel group polysomnography study to assess the efficacy and safety of a 16 day oral administration of ACT 078573 in adult subjects with chronic primary insomnia.
    A.4.1Sponsor's protocol code numberAC-057A301
    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 SponsorActelion Pharmaceuticals Ltd
    B.1.3.4CountrySwitzerland
    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 nameACT-078573
    D.3.2Product code ACT-078573
    D.3.4Pharmaceutical form Film-coated tablet
    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 codeACT-078573
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Stilnox®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis (Switzerland) AG
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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.3.4Pharmaceutical 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.3.8INN - Proposed INNZolpidem tartrate
    D.3.9.1CAS number 82626-48-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    Chronic 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 10022437
    E.1.2Term 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 demonstrate an effect of ACT 078573 at 200 mg at treatment start and at 16 days on a set of objective sleep-maintenance endpoints and over 2 weeks on subjective sleep-maintenance endpoint.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to demonstrate an effect of ACT 078573
    • at 200 and 100 mg at treatment start and at 16 days on a set of objective endpoints (Sleep-Initiation, Total Sleep Time, Sleep Quality and delayed Word Recall Test) and over 2 weeks on a set of subjective endpoints (Sleep Initiation, Total Sleep Time, Sleep Quality and delayed Word Recall Test).
    • at 100 mg at treatment start and at 16 days on a set of objective Sleep Maintenance endpoints and over 2 weeks on a subjective Sleep Maintenance endpoint.

    Also included in the secondary objectives is an evaluation of the safety and tolerability of a 16-day oral administration of AC 078573 at doses of 200 and 100 mg.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent prior to any study mandated procedure.
    2. Male or female aged 18–64 years (inclusive) at screening.
    • Women of childbearing potential must have negative pregnancy tests before randomization and consistently and correctly use (from screening, during the entire study, and for at least 1 month after study drug intake) a reliable method of contraception with a failure rate of < 1% per year (such as implants, injectables, combined oral hormonal contraceptives, some intrauterine devices), sexual abstinence, or vasectomised partner.
    • Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea at least 1 year), or surgically or naturally sterile.
    3. Body mass index ≥18.5 and < 32 kg/m2.
    4. Primary insomnia by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM IV TR®) criteria.
    5. Self reported history of the following for at least 3 months prior to the screening visit:
    - Usual time to fall asleep ≥ 30 min
    - Usual wake time during sleep ≥ 30 min
    - Usual total sleep time < 6.5 h.
    confirmed on at least 3 nights (out of 7 consecutive nights prior to Visit 2) on the screening Sleep Diary.
    6. Usual bedtime between 20:00 and 01:00
    confirmed on at least 5 nights (out of 7 consecutive nights prior to Visit 2) on the screening Sleep Diary.
    7. Mean LPS ≥ 20 min (with no night < 15 min), mean WASO ≥ 20 min (with no night < 15 min), and mean TST < 420 min on the 2 PSG screening nights.
    8. Ability to communicate well with the investigator, and to understand the study requirements.
    E.4Principal exclusion criteria
    a. History of any sleep disorder other than primary insomnia.
    b. Any axis I disorder other than primary insomnia according to the DSM IV TR® criteria within 6 months prior to the screening visit.
    c. Apnea / hypopnea index (AHI) ≥ 10/h on the first PSG screening night.
    d. Apnea or hypopnea event associated with oxygen saturation by pulse oximetry (SpO2) < 80%, on the first PSG screening night.
    e. Periodic limb movement arousal index (PLMAI) ≥ 10/h on the first PSG screening night.
    f. Usual daytime napping ≥ 1 hour per day, and ≥ 3 days per week.
    g. Important caffeine consumption (≥ 500 mg per day).
    h. Pregnancy or breast feeding.
    i. Shift work within 3 months prior to the screening visit, planned shift work during study, travel ≥ 3 time zones within 1 week prior to the screening visit, planned travel ≥ 3 time zones during study, or history of circadian rhythm disorders.
    j. Hematology or biochemistry test results deviating from the normal range to a clinically relevant extent.
    k. Alcohol or drug abuse within 1 year prior to the screening visit, or inability to refrain from drinking alcohol for at least 3 consecutive days.
    l. Positive drug test (for benzodiazepines, barbiturates, cannabinoids, opiates, amphetamines, or cocaine) or positive alcohol test on the evening of the PSG screening nights.
    m. Inability to refrain from smoking for at least 14 hours during the night.
    n. Unstable medical condition, significant medical disorder within 1 month prior to the screening visit or acute illness at the screening visit.
    o. Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements.
    p. Treatment with Cognitive Behavioral Therapy (CBT) within 1 week prior to the first day of completion of the screening Sleep Diary
    q. Unwillingness to refrain from prohibited CNS active drugs (see Appendix 2) for 5 half lives of the respective drug (but at least 1 week) prior to the first day of completion of the screening Sleep Diary, until 24 hours after the last administration of study treatment.
    r. Treatment with moderate or strong inhibitors of CYP3A4 (see Appendix 12) within 1 week prior to the first PSG screening night.
    s. Treatment containing simvastatin or lovastatin, at daily doses higher than 20mg, within 1 day prior to the first PSG screening night.
    t. Known hypersensitivity or contraindication to drugs of the same class as the study treatment, or any excipients of the drug formulations, or to zolpidem.
    u. Treatment with another investigational drug within 1 month prior to the screening visit.
    v. Treatment with drugs metabolized by CYP2D6 isoenzyme with a narrow therapeutic index (see Appendix 12), within 1 day prior to the first PSG screening night.
    W. Heart rate < 50 bpm on screening 12-lead ECG
    E.5 End points
    E.5.1Primary end point(s)
    The change in sleep-maintenance as compared to pre treatment is chosen as the primary endpoint; it includes the following components:
    • Change from Baseline* to Day 1&2* in WASO.
    • Change from Baseline* to Day 15&16*in WASO.
    • Change from Baseline# to Week 1&2# in sWASO.

    * ‘Baseline’ is the mean of the 2 PSG screening nights. ‘Day 1&2’, ‘Day 15&16’ are the mean of the corresponding 2 PSG treatment nights.

    # ‘Baseline’ is the mean value of the screening Sleep Dairy entries at home between Visit 2 and 3.
    ‘Week 1&2’ is the mean value based on the Sleep Diary entries at home under double-blind study treatment (between Visit 3 and 4).

    WASO is the time spent awake after onset of persistent sleep (time spent in epochs scored as wake after onset of persistent sleep – see the definition of LPS) until ‘lights on’ as determined by PSG.

    sWASO is the self-reported time spent awake after sleep onset as reported in the Sleep Diary.

    Assumptions for sample size estimation:
    • a WASO difference of 20 min compared to placebo is to be detected.
    • normal distribution of the change from Baseline* in WASO with a standard deviation of 40 min.
    • an sWASO difference of 20 min compared to placebo is to be detected.
    • normal distribution of the change from Baseline# in sWASO with a standard deviation of 50 min.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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 years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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 state370
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 490
    F.4.2.2In the whole clinical trial 668
    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)
    N/A- Expected normal treatment
    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 Decision2008-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-10-16
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