EUCTR2006-006075-20-FR进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (sodium oxybate) in Subjects with Fibromyalgia
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 525
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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), anticonvulsants, antidepressants, dopamine agonists and/or tramadol, 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 behavioural, 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 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 apnoea using the Berlin Questionnaire, and a determination of the subject’s sleep apnoea status has been made.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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
- •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.
- •4. Subject has Generalized Anxiety Disorder
- •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
- •8. Subject has a clinically significant history of seizure disorder either past or present, a history of clinically significant head trauma, 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.
- •12. Subject has taken gamma-hydroxybutyrate or sodium oxybate or Xyrem at any time.
- •13. Subject has taken any investigational therapy within 2 months prior to signing informed consent.
- •14. Subject is unable to discontinue certain prohibited medications during the washout period and throughout the duration of the trial., e.g. antidepressants, mood-stabilizers, antipsychotics, NSAIDs, opiods, muscle relaxants
- •15. Subject is experiencing clinically significant medication withdrawal symptoms after the withdrawal/washout period.
- •16. Subject is experiencing fatigue and/or drowsiness/sedation in association with intake of allowed medications.
- •17. Subject has an allergic reaction to GHB or sodium oxybate or any of its constituents (malic acid).
- •18. Subject has any protocol defined exclusionary clinical laboratory tests
- •19. Subject is diagnosed with sleep apnea and not currently on stable continuous positive airway pressure (CPAP) therapy for the last 30 days prior to baseline.
- •20. Subject has a body mass index (BMI) of greater than or equal to 35.
- •21. Subject is on a sodium-restricted diet.
- •22. Subject has a visual impairment or motor disturbance which precludes capacity to make accurate notation on the electro
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