EUCTR2013-005164-26-GB进行中（未招募）1 期
An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated with Fibromyalgia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,088
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
入选标准
- •Subjects who completed one of the preceding Phase 3 DS-5565 study (DS5565-A-E309, DS5565-A-E310, or DS5565-A-E311):
- •1. Able to give written informed consent
- •2. Completed participation (i.e. completed the End-of-Tapering visit) in a preceding study of DS-5565 in FM (DS5565-A-E309, DS5565-A-E310, or DS5565-A-E311)
- •3. Women of child-bearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy during the study and for 4 weeks after study completion
- •4. The subject must not have experienced any significant safety issues during the preceding study that, in the investigator’s judgment, would adversely impact the subject’s well-being in the long-term extension
- •De Novo Subjects:
- •5. Age = 18 years
- •6. Able to give written informed consent
- •7. Able to complete subject-reported questionnaires per the investigator’s judgment
- •8. At screening, subjects must meet the 1990 American College of Rheumatology (ACR) criteria for FM, i.e. widespread pain present for at least 3 months and pain in at least 11 of 18 specific tender point sites. In addition, the 2010 ACR criteria must be met:
- •Widespread pain index (WPI) = 7 and symptom severity (SS) scale score = 5, or WPI 3 to 6 and SS scale score = 9
- •Symptoms have been present at a similar level for at least 3 months
- •The subject does not have a disorder that would otherwise explain the pain
- •9. ADPS of = 4 on the 11-point numeric rating scale (NRS) over the past 7 days prior to first dose (based on completion of at least 4 daily pain diaries during the 7-day baseline period)
- •10. Subject must have documented evidence of a fundoscopic examination (with pupil dilation) or a scanning laser opthalmoscopy examination within 12 months prior to screening or at screening
- •11. Women of child-bearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy during the study and for 4 weeks after study completion
- •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 924
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 231
排除标准
- •All Subjects:
- •1. Clinically significant unstable neurologic, psychiatric, ophthalmologic, hepatobiliary, respiratory, or hematologic illness or unstable cardiovascular disease (e.g. severe hypotension, uncontrolled cardiac arrhythmia, or myocardial infarction) or any other concurrent disease during the preceding study (for rollover subjects) or within 12 months prior to screening (for de novo subjects) that in the opinion of the investigator would interfere with study participation or assessment of safety and tolerability
- •2. Subjects who are at risk of suicide as defined by their responses to the Columbia-Suicide Severity Rating Scale (C-SSRS) or in the opinion of the investigator. Note: Subjects answering yes” to any of the questions about active suicidal ideation/intent/behaviors occurring within the past 12 months must be excluded (C-SSRS Suicide Ideation section – Questions 3, 4, or 5; C-SSRS Suicidal Behavior section, any of the suicide behaviors questions). Such subjects should be referred immediately to a mental health professional for appropriate evaluation.
- •3. Subjects who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the investigator to be unlikely to complete the study
- •4. Subjects with severe or uncontrolled depression that, in the judgment of the investigator, makes the subject inappropriate for entry into the study
- •5. Subjects with pain due to other conditions (e.g. diabetic peripheral neuropathic pain or post-herpetic neuralgia) that, in the opinion of the investigator, would confound assessment or self-evaluation of the pain associated with FM
- •6. Subjects with pain due to any widespread inflammatory musculoskeletal disorder (e.g. rheumatoid arthritis, lupus) or widespread rheumatic disease other than FM.
- •7. Abuse or dependence of prescription medications, street drugs, or alcohol within the last 1 year
- •8. Any history of a malignancy other than basal cell carcinoma within the past 5 years
- •9. A diagnosis of untreated sleep apnea or initiation of treatment for sleep apnea within the past 3 months
- •10. Known hypersensitivity to a2d ligands or other components of the study medications
- •11. Pregnancy or breast-feeding, or intent to become pregnant during the study period
- •12. Abnormal investigative tests (i.e. ECGs) and laboratory values judged by the investigator to be clinically significant at the End-of-Treatment visit (Visit 11, Week 13) in the preceding study (for rollover subjects) or at screening (for de novo subjects), with particular focus on:
- •Abnormal renal function defined as calculated CrCl < 60 mL/min determined by the central laboratory using the Cockcroft-Gault equation(4); blood urea nitrogen> 1.5 × ULN; serum creatinine > 1.6 mg/dL (> 141.4 µmol/L); or
- •Abnormal liver function defined as AST (SGOT) > 2.0 × ULN, ALT (SGPT) > 2.0 × ULN; alkaline phosphatase > 1.5 × ULN; total bilirubin> 1.2 × ULN. If a subject has total bilirubin > 1.2 ULN, unconjugated and conjugated bilirubin fractions should be analyzed and only subjects documented to have Gilbert’s syndrome may be enrolled; or
- •Creatinine kinase> 3.0 x ULN;
- •For De Novo Subjects Only:
研究者
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