Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36373   clinical trials with a EudraCT protocol, of which   5993   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2008-002164-34
    Sponsor's Protocol Code Number:12495A
    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:2008-10-30
    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 number2008-002164-34
    A.3Full title of the trial
    Randomised, double-blind, 3-way crossover, single dose, placebo-controlled study investigating the effect on postural instability of melatonin and zolpidem in healthy elderly subjects
    A.4.1Sponsor's protocol code number12495A
    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 SponsorH. Lundbeck A/S
    B.1.3.4CountryDenmark
    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 Yes
    D.2.1.1.1Trade name Circadin 2 mg prolonged-release tablets
    D.2.1.1.2Name of the Marketing Authorisation holderRAD Neurim Pharmaceuticals EEC Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Prolonged-release 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.3.8INN - Proposed INNMelatonin
    D.3.9.1CAS number 73-31-4
    D.3.9.2Current sponsor codeAE-67644
    D.3.9.3Other descriptive nameN-Acetyl-5-methoxytryptamine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Zolpidem STADA 5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderSTADApharma
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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.3.8INN - Proposed INNZolpidem Tartrate
    D.3.9.1CAS number 99294-93-6
    D.3.9.3Other descriptive nameN,N-Dimethyl-2-(6-methyl-2-p-tolyimidazo(1,2-a)pyridin-3-yl)acetamid hemitartrate
    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*
    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 placeboProlonged-release tablet
    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
    Effect on postural instability of Melatonine and Zolpidem in healthy elderly subjects
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to compare the effect of melatonin (Circadin® 2 mg, RAD Neurim Pharmaceuticals EEC Limited; Berkshire, UK) on postural instability with that of placebo when administered as single doses in the evening
    E.2.2Secondary objectives of the trial
    to compare the effect of zolpidem (Zolpidem STADA® 5 mg, STADApharma, Bad Vilbel, Germany) on postural instability with that of placebo when administered as single doses in the evening
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject is able to read and understand the Subject Information and Informed Consent Form.
    2. The subject and the clinical study physician have signed a study-specific Informed Consent Form. No study-related procedures, including any screening procedures, may be performed before the clinical study physician has obtained written informed consent from the subject.
    3. The subject is a healthy man or woman.
    If a man, the subject must:
     use two contraceptive methods together with his female partner, if she is of childbearing potential; this combination of contraceptive methods must be used from the start of the clinical study until at least 3 months after the last dose of IMPs. At least one of the contraceptive methods must be a barrier contraceptive method. Contraceptive methods allowed include the following: condoms; diaphragm in combination with a spermicide; intrauterine device (IUD, loop); contraception implants; ”mini pills” (with gestagens only); injectable gestagens; combination hormonal contraceptive methods (tablet, patch, or vaginal ring with both ethinylestradiol and gestagen), OR
     not be sexually active at enrolment in the clinical study and accept using two contraceptive methods should he become sexual active during or within 3 months after the last dose of IMP, OR
     have been surgically sterilised before inclusion, OR
     have a partner who is post-menopausal and has had her last natural menstruation at least 24 months before his inclusion, OR
     have a partner who has had a hysterectomy before his inclusion, OR
     have a female partner who has been surgically sterilised before his inclusion
     If a woman, the subject must:
     be post-menopausal and have had her last natural menstruation at least 24 months before her inclusion
    4. The subject is 65 years to 75years of age
    5. The subject has a BMI 19 kg/m2 and 30 kg/m2 at the Screening Visit
    6. The subject has normal vital signs after resting for 5 minutes in supine position
     pulse and heart rate as recorded on the ECG: 51 bpm and 100 bpm
     systolic blood pressure: 91 mmHg and 150 mmHg
     diastolic blood pressure: 51 mmHg and 90 mmHg
    7. The subject has normal 12-lead ECG after 10 minutes resting in supine position (in particular QTc < 450 ms)
    8. The subject has an orthostatic blood pressure <20 mmHg (based on the difference between supine and standing [1 minute] systolic blood pressure).
    9. The subject has clinical laboratory test values within the reference ranges. Borderline values may be accepted if they are, in the opinion of the investigator, not clinically relevant
    10. The subject has a normal circadian rhythm, defined as a person who usually wakes between 06:00 and 09:00 and goes to sleep between 21:00 and 24:00
    11. The subject is, in the opinion of the investigator, generally healthy based on assessment of medical history, physical examination, vital signs, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests
    12. The subject is covered by a Health Insurance System where applicable, and in compliance with the recommendations of national laws in force relating to biomedical research
    13. The subject is not under any administrative or legal supervision.
    E.4Principal exclusion criteria
    1. The subject has taken disallowed medication within 1 week prior to the first dose of IMP (or within 5 half-lives prior to baseline for any medication ingested, whichever is longer). Disallowed medication is any prescribed medication or over-the-counter (OTC) medication as well as any herbal medicine known to interfere with the metabolic CYP pathways, such as St. John’s Wort (except for hormonal contraceptives or hormonal substitution therapy). Subjects who have taken any non-prescribed systemic or topical medication may still be entered into the study if, in the opinion of the investigator, the medication will not interfere with the study procedures, study results, or compromise safety.
    2. The subject weight >136 kg.
    3. The subject cannot stand erect and unsupported for more than 2 to 3 minutes or loses balance when standing on a fixed surface with eyes open.
    4. The subject has an excessive consumption of beverages on xanthine bases (more than 4 cups or glasses daily).
    5. The subject has a presence or history of alcohol abuse defined as alcohol consumption greater than 21 units per week for men and greater than 14 units per week for women (a unit of alcohol is defined as 250 mL of lager/beer, 100 mL of wine, or 25 mL of spirits); or a presence or history of drug abuse within the last 6 months, or a history of substance abuse deemed relevant by the investigator.
    6. The subject has taken any investigational products within 3 months prior to baseline.
    7. The subject has taken the IMPs earlier in this clinical study.
    8. The subject has participated in a previous clinical study with any of the IMPs
    9. The subject has known hypersensitivity to the IMP, zolpidem or their excipients.
    10. The subject has a history of severe drug allergy or hypersensitivity.
    11. The subject has a presence or history of sleep disorder, fainting, cardiovascular diseases, carotid sinus syndrome, relevant dizziness or arrhythmia.
    12. The subject is a regular user (used more than once in a week) of hypnotics, tranquiliers or other drugs to induce sleep.
    13. The subject has a history of or presence of any clinically relevant immunological, cardiovascular, pulmonary, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, systemic, ocular or psychiatric or infectious disease or other major disorder, or sign of acute illness.
    16. The subject has any concurrent illness that may affect the particular target or the metabolism of the IMPs.
    17. The subject has had a clinically relevant illness within 4 weeks before the first dose of IMP.
    18. The subject has had surgery or trauma with notable blood loss within the last 3 months before the first dose of IMP.
    19. The subject has donated blood within 1 month before the first dose of IMP.
    20. The subject has tested positive for anti-human immunodeficiency virus (HIV) 1 and 2 antibodies; hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV-Ab).
    21. The subject’s QTc (Bazett’s or Fridericia’s correction) is >450 ms (at the Screening Visit or at the Safety Baseline Visit) as read on the printout of the ECG produced by the ECG equipment and evaluated by the investigator.
    22. The subject smokes more than 10 cigarettes daily or uses equivalent of other nicotine-containing products (such as snuff, nicotine patch, nicotine chewing gum, mock cigarette, inhaler, pipe).
    23. The subject has tested positive at the Screening Visit or at the day of admission in each Dosing Period (Day 1, 8 and 15) for drugs of abuse (opiates, methadone, cocaine, amphetamines/methamphetamines (including ecstasy), barbiturates, benzodiazepines and cannabinoids).
    24. The subject has tested positive at the Screening Visit or at the day of admission in each Dosing Period (Day 1, 8 and 15) for alcohol.
    25. The subject has worked on shifts including night duty within 3 weeks before first the first dose of IMP.
    26. The subject exercises extensively in his/her normal life, such as marathon running, triathlon, physical sports at a competitive level.
    27. The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
    28. The subject cannot be contacted in case of emergency
    29. The subject has failed to give written informed consent prior to any procedure related to the clinical study
    30. Any subject who is the investigator or any sub-investigator, research assistant, pharmacist, clinical study coordinator, or other staff thereof, directly involved in the conduct of the clinical study
    31. Vulnerable subjects (for example subjects kept in detention).

    E.5 End points
    E.5.1Primary end point(s)
    Postural instability of Melatonine and Zolpidem after a single oral dose of 2 mg Melatonine and 5 mg Zolpidem respectively.
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Compare effect of Melatonine and Zolpidem on postural instability with Placebo
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    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
    LVLS is defined as the End of Trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state24
    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 Decision2009-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-11
    P. End of Trial
    P.End of Trial StatusCompleted
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA