EUCTR2017-001294-16-PL进行中（未招募）1 期
A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 420
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. Capable of understanding and complying with the protocol
- •2. Male and female adults aged 18 to 65 years, inclusive
- •3. Has a confirmed diagnosis of RRMS
- •4. Neurologically stable with no evidence of relapse within 30 days prior to randomization (Visit 3)
- •5. Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration or is surgically sterile or post-menopausal
- •6. Additional criteria may apply
- •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 475
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Have any finding(s) that would compromise the safety of the subject, affect the subject’s ability to adhere to the protocol visit schedule or to fulfill visit requirements, or would make the subject unsuitable for participation in the study
- •2. Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
- •3. History of clinically significant cardiovascular, pulmonary, gastrointestinal, dermatologic, psychiatric, neurologic (other than MS), endocrine, renal and/or other major disease that would preclude participation in a clinical trial
- •4. History of GI surgery (except appendectomy that occurred more than 6 months prior to screening; other prior surgeries may be permitted based on Medical Monitor approval)
- •5. History of clinically significant recurring or active gastrointestinal symptoms within 3 months of screening
- •6. Chronic use (=7 days) of medical therapy to treat any GI symptoms within 1 month of screening
- •7. Has a clinically significant medical condition or observed abnormality at screening
- •8. History of a myocardial infarction, including a silent myocardial infarction identified on ECG, or unstable angina
- •9. History of clinically significant drug or alcohol abuse within the past year prior to screening
- •10. Any of the following abnormal blood tests at screening (Visit 1):
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =2 times the upper limit of normal (ULN)
- •Thyroid-stimulating hormone (TSH) level higher than the ULN by 10% or more at screening
- •Estimated glomerular filtration rate (eGFR) =60 mL/min/1.73m2 (using the CKD EPI equation; (Levey, Stevens et al. 2009)
- •Lymphocyte count <0.9 x 103/µL
- •11. Any of the following abnormal urine tests at screening (Visit 1):
- •Beta-2 microglobulin >0.3 µg/mL
- •Albumin to creatinine ratio >200 mg/g
- •12. Clinically significant history of suicidal ideation or suicidal behavior in the last 12 months
- •13. Subject is pregnant or breastfeeding or plans to become pregnant or begin breastfeeding at any point during the study and for 30 days after any study drug administration
- •14. Steroids, with the exception of topical or inhaled steroids, or IV
- •immunoglobulin within 30 days prior to randomization (Visit 3)
- •15. Prior treatment with Fumaderm or Tecfidera
- •16. Additional criteria may apply
研究者
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