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    Summary
    EudraCT Number:2007-002222-30
    Sponsor's Protocol Code Number:06-015
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-07-24
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2007-002222-30
    A.3Full title of the trial
    Single- and Multiple-Dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Sodium Oxybate (Xyrem®) in Subjects with Moderate to Severe Essential Tremor
    A.4.1Sponsor's protocol code number06-015
    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 SponsorJazz Pharmaceuticals Inc.
    B.1.3.4CountryUnited States
    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 Xyrem 500 mg/ml oral solution
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation number23 February 2003
    D.3 Description of the IMP
    D.3.1Product nameXyrem 500 mg/mL oral solution
    D.3.4Pharmaceutical form Oral solution
    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.3.9.3Other descriptive nameSodium Oxybate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Yes
    D.3.11.13.1Other medicinal product typeChemical entity from synthetic route
    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 placeboOral solution
    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
    Patients undergoing moderate or severe classic essential tremor
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10032297
    E.1.2Term Other nervous system complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the relationship between drug plasma levels and safety, tolerability, and efficacy in subjects with moderate to severe essential tremor after single and multiple doses of sodium oxybate.
    E.2.2Secondary objectives of the trial
    - To determine the efficacy and PD of single, escalating doses of sodium oxybate in subjects with ET
    - To determine the PK and PD of multiple doses designed to simulate sustained delivery of sodium oxybate
    - To assess the safety and tolerability of sodium oxybate using single- and multiple-dose regimens
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of moderate or severe classic essential tremor (bilateral, largely symmetric postural or kinetic tremor involving hands and forearms that is visible and persistent). with a score of 2 to 4 on the Fahn-Tolosa-Marin Essential Tremor Rating Scale
    2. Male and female subjects age 50 to 75 years, inclusive.
    3. Inability to reproduce a nearly perfect spiral drawing using the hand that experiences the more severe tremor (tremor is not necessarily better or worse in the dominant hand).
    4. Willingness and ability to safely stop and remain off any medications used to treat ET for at least five half-lives prior to Day 1 and for the duration of the study.
    5. Willingness to abstain from ethanol and caffeine intake for at least 48 hours prior to Days 1 and 4 and on inpatient days.
    6. Good general health as determined by physical examination, medical history, clinical laboratory findings, and ECG at screening, as determined by the investigator.
    7. Consent to use a medically acceptable method of contraception throughout the entire study period and for 1 week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or the partner include abstinence, birth control pills or patches or vaginal ring, diaphragm and spermicide, intrauterine device (IUD), condom and vaginal spermicide, surgical sterilization, post-menopausal partner, vasectomy (>6 months prior to baseline), and progestin implant or injection.
    8. Negative screens for HIV Ab, HbsAg, and HCV-Ab and no history of a positive result.
    9. Negative urine drug and alcohol screens at screening and baseline (Day -1).
    10. Hemoglobin of 12.0 g/dL or greater.
    11. Ability to read, understand, and provide written informed consent before enrolling in the study, and willingness to comply with all study procedures.
    12. Agreement to remain in the study facility for approximately 6 study days.
    13. Negative pregnancy test for all females at screening and baseline (Day -1).
    E.4Principal exclusion criteria
    1. Subjects with a clinically significant unstable medical abnormality, chronic disease, or history or presence of significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, psychiatric, or metabolic disease or any other abnormality (other than essential tremor) that could interfere with the pharmacokinetic evaluation of the study drug.
    2. Subjects with succinic semialdehyde dehydrogenase deficiency (SSDD).
    3. Subjects currently taking primidone (Mysoline®).
    4. Subjects with any severe drug allergy or a history of allergic or severe adverse reactions or intolerance to sodium oxybate.
    5. Subjects who are on sodium-restricted diets.
    6. Subjects who are color blind.
    7. Subjects with deep brain stimulators (DBSs).
    8. Subjects with a known history of sleep apnea.
    9. Subjects who have previously used Xyrem® or GHB (gamma hydroxybutyrate).
    10. Subjects with clinically significant illness within 30 days of screening, as determined by the investigator.
    11. Subjects with a clinically significant abnormal finding (other than essential tremor) on physical examination, ECG, or clinical laboratory tests, as determined by the investigator.
    12. Females who are pregnant, breastfeeding, or lactating.
    13. Subjects who self-report ingestion of alcohol ingestion within 48 hours prior to dosing through completion of the study.
    14. Subjects who self-report significant abuse of tobacco (>10 cigarettes or equivalent per day), analgesics, tranquilizers, opioids, mood-altering drugs, or known drug dependence prior to Day -1, or have used tobacco products or products, including nicotine-containing products, for smoking cessation within 90 days before screening.
    15. Subjects who used any prescription medication within 14 days or over-the-counter (OTC) medication within 7 days of randomization or intends to use any prescription or OTC medication during the study that may interfere with the evaluation of the study drug. Exceptions, to be discussed with the medical monitor prior to admission to the study, can include stable doses of: cholesterol-reducing medications and hormonal replacement therapy.
    16. Subjects who used any other investigational drug within 30 days or five half-lives (whichever is longer) before dosing, or plans to use an investigational drug (other than the study drug) during the study.
    17. Subjects who self-report excessive consumption of xanthine-containing products (coffee, tea, cola) (i.e. > 500 mg per day of caffeine, or approximately 4 cups of coffee per day).
    18. Subjects who self-report consumption of xanthine-containing products (coffee, tea, cola) or grapefruit or quinine-containing products within 48 hours before dosing through to completion of the study (Day 6).
    19. Subjects who have made any blood donation within 56 days of randomization.
    20. Subjects who have made any plasma donation within 7 days of randomization.
    21. Subjects with a history, or suspicion, of inability to comply fully with all procedural aspects of this study.
    22. Subjects with cognitive impairment preventing informed consent or cooperation during the study.
    E.5 End points
    E.5.1Primary end point(s)
    1. Pharmacokinetics parameters for Xyrem
    2. safety parameters
    3. Pharmacodynamic parameters (Rating scales to evaluate Tremor, sedation, cognition and global impression of change; writing test on a Digital Writing Pad)
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    open in the first part, then double-blind in the second part; Cross-over in the second part only
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    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 No
    F.3.2Patients Yes
    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
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    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 Decision2007-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-31
    P. End of Trial
    P.End of Trial StatusOngoing
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