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    Summary
    EudraCT Number:2006-006075-20
    Sponsor's Protocol Code Number:06-009
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-06-03
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-006075-20
    A.3Full title of the trial
    A Randomized, Double Blind, Placebo Controlled, Safety and Efficacy Study of Xyrem (sodium oxybate) in Subjects with Fibromyalgia
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code number06-009
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 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 nameXyrem
    D.3.4Pharmaceutical form Oral drops, 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.3.8INN - Proposed INNHydroxybutyric acid
    D.3.9.1CAS number 502852
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 typeNon Applicabile
    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 nameSodium Oxybate oral solution 375 mg/ml
    D.3.4Pharmaceutical form Oral drops, 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.3.8INN - Proposed INNHydroxybutyric acid
    D.3.9.1CAS number 502852
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    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 typeNon Applicabile
    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 drops, solution
    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 placeboOral drops, 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
    Fibromyalgia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10048439
    E.1.2Term Fibromyalgia
    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 safety and efficacy of Xyrem (sodium oxybate) oral solution at 4.5 g/night and 6 g/night compared to placebo for the treatment of fibromyalgia in a randomized, double-blind, placebo controlled, parallel-group trial.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for trial participation if he/she meets the following criteria (see protocol section 8.1.1 for details): 1. Subject is able to understand the written informed consent and has signed and dated the consent prior to beginning protocol required procedures. 2. Subject is willing and able to complete the entire trial as described in the protocol. 3. Subject is male or female 18 years of age or older. 4. Subject meets the ACR criteria for fibromyalgia at screening and at baseline. 5. Subject has at least 5 out of 7 days with 100% compliance on the VAS self-rated pain scale in the week prior to Visit 4 and has an average VAS pain score of greater than or equal to 50 mm/100 mm as recorded in the subject diary on the 100% compliant days, defined as days that the morning, afternoon, and evening diaries were all completed. 6. Subject is willing to discontinue opiates, benzodiazepines, muscle relaxants (cyclobenzaprine [Flexeril]), anticonvulsants, antidepressants, dopamine agonists and/or tramadol (Ultram), or any other medications, herbal remedies, and/or devices being used to treat their fibromyalgia symptoms until trial completion. 7. Subjects who are on a consistent nutritional and/or exercise regimens and/or behavioral, massage, physical, or cognitive therapies for the last 3 months prior to baseline are willing to agree to remain on an unchanged regimen throughout the duration of the trial. 8. Subject agrees to use only acetaminophen (paracetamol) as rescue pain medication and to limit the dose to a maximum of 4 g/day throughout the course of the trial. Subjects may, for cardiac protection, take a single daily dose of 325 mg or less of aspirin. Any other use of aspirin is prohibited during this trial. 9. Subject is willing to discontinue the ingestion of alcohol for the duration of the trial. 10. Female subjects may be included if they are surgically sterile or 2 years post menopausal, but they must also have a negative pregnancy test. Female subjects of child bearing potential and peri-menopausal subjects may be included but must have a negative pregnancy test and agree to use a medically accepted method of birth control (eg, barrier method with spermicide, oral contraceptive, or abstinence) and agree to continue use of this method for the duration of the trial. 11. Subject has been screened for sleep apnea using the Berlin Questionnaire, and a determination of the subject’s sleep apnea status has been made.
    E.4Principal exclusion criteria
    A subject will be excluded from the trial if he/she meets any of the following criteria (see Protocol section 8.1.2 for details): 1. Subject has any of the following medical conditions: Rheumatic disease in addition to fibromyalgia, such as rheumatoid arthritis, inflammatory arthritis, or systemic lupus erythematosus Painful osteoarthritis and symptomatic osteoarthritis that may interfere with the subject’s or investigator’s ability to measure change on any outcome measures and/or compromise the objectives outlined in the protocol e.g. osteoarthritis associated with stiffness and muscle weakness Pain from traumatic injury Uncontrolled hypo- or hyperthyroidism of any type Autoimmune disease Multiple sclerosis Unstable cardiovascular, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological, pulmonary, and/or renal disease Neoplastic (excluding localized basal cell carcinoma) disease Systemic infection Any disease, disorder or condition that would place the subject at risk during the trial, interfere with the subject’s or investigator’s ability to measure change on any outcome measures and/or compromise the objectives outlined in the protocol 2. Subject has a history of myocardial infarction, transient ischemic attack (TIA) or cerebrovascular accident (CVA). 3. Subject has a Major Depressive Disorder or is currently being treated for a Major Depressive Disorder or has a history of psychotic disorder and/or bipolar disorder. Subjects being considered for discontinuation of antidepressant medication require careful evaluation as to any risks from cessation of antidepressant therapy. If, in the opinion of the investigator, a reasonable risk of resultant subject harm exists, the subject will be excluded from study participation. 4. Subject has Generalized Anxiety Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders IV, Text Revision (DSM IV-TR). 5. Subject has any other problems that, in the investigator's opinion, would preclude the subject's participation and completion of this trial or compromise reliable representation of subjective symptoms. 6. Subject has a MINI suicidality module score > 0 and/or subject who answers “yes” to the suicide question (A3-g) on the Major Depressive Episode module of the MINI and/or greater than or equal to 1 on Question 9 of the BDI-II. 7. Subject has a current or past history of a substance use disorder including alcohol abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders IV, Text Revision (DSM IV-TR). 8. Subject has a clinically significant history of seizure disorder either past or present, a history of clinically significant head trauma (i.e. concussion resulting in clinically significant loss of consciousness), chronic persistent migraine headaches, or past invasive intracranial surgery. 9. Subject has known succinic semialdehyde dehydrogenase deficiency. 10. Subject has participated in a previous Xyrem (sodium oxybate) clinical trial. 11. Subject has received acupuncture therapy intended for the treatment of fibromyalgia within 30 days prior to baseline.
    E.5 End points
    E.5.1Primary end point(s)
    Two primary efficacy parameters (1 and 2) will be evaluated. Primary efficacy parameter 1 is a composite parameter for the treatment of pain associated with fibromyalgia. The proportion of subjects in each treatment group that meet both of the following response criteria will be compared to assess the efficacy of Xyrem (sodium oxybate) in response to pain associated with fibromyalgia. Pain Severity: Overall pain severity will be assessed by pain VAS data recorded 3 times a day by the subject in an electronic diary. For pain VAS, a response is defined as a reduction in average pain of more than or equal to 20% from baseline to endpoint. Patient Global Impression of Change: The subject’s perception of the overall improvement in their fibromyalgia symptoms will be assessed by means of the PGIc questionnaire completed at endpoint. A response to treatment is defined as a response of “Very much better” or “Much better” on the PGIc. Primary efficacy parameter 2 is a composite parameter for the treatment of fibromyalgia syndrome. The proportion of subjects in each treatment group that meet all 3 of the following response criteria will be compared to assess the efficacy of Xyrem (sodium oxybate) in response to fibromyalgia syndrome. Pain Severity: Overall pain severity will be assessed by pain VAS data recorded 3 times a day by the subject in an electronic diary. For pain VAS, a response will be defined as a reduction in average pain of more than or equal to 20% from baseline to endpoint. Functionality (Fibromyalgia Impact Questionnaire): Change from baseline to endpoint will be assessed. A response will be defined as a reduction of more than or equal to 20% in FIQ total score from baseline to endpoint. For example, if a subject has a baseline FIQ score of 40, they will need to have an FIQ score of 32 or less at endpoint, to be considered a responder. Patient Global Impression of Change: The subject’s perception of the overall improvement in their fibromyalgia symptoms will be assessed by means of the PGIc questionnaire completed at endpoint. A response will be defined as a response of “Very much better” or “Much better” on the PGIc. Primary efficacy parameter 2 will not be tested unless primary efficacy parameter 1 demonstrates a significant treatment difference in favor of Xyrem (sodium oxybate).
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) 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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-06-03. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 210
    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)
    After visit 11 (at week 14), subjects will be asked to participate in a long-term, open-label study under a separate protocol and ICF. Patients not participating in the long-term study will have a follow-up safety check two weeks post-dose. They will have a review of concomitant medication use and a vital sign measurements (heart rate, sitting blood pressure, temperature and respiratory rate); AEs will be recorded. For full information refer to Protocol, section 9.1.1.
    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 Decision2008-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-08
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