EUCTR2011-006291-39-BE进行中（未招募）1 期
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With First Episode of Acute Optic Neuritis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- •2. Males and females with a confirmed diagnosis (by a physician with expertise in diagnosis and treatment of diseases of the optic nerve) of a first episode of unilateral AON with an onset within 28 days prior to study dosing at Day 1/Baseline. The diagnostic criteria of AON should include at least 2 of the following: reduced visual acuity, afferent pupillary defect, color vision loss, visual field abnormality, and/or pain on eye movement. Onset of ocular pain alone cannot be used to determine the onset of AON. Subjects are allowed to enroll regardless of if there are demyelinating lesions on brain MRI.
- •3. Aged 18 to 55 years old, inclusive, at the time of informed consent.
- •4. Must have received treatment of AON with 1 gram IV methylprednisolone for a minimum of 3 days and a maximum of 5 days prior to randomization.
- •5. All male or female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment.
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior episode(s) of optic neuritis or any other previous clinical CNS demyelinating events characteristic of MS as determined by a physician with expertise in the diagnosis and treatment of MS.
- •2. Subjects with an established diagnosis of MS are excluded except if newly diagnosed based on the current episode of AON and positive brain MRI results consistent with the 2010 revisions to the McDonald’s criteria. [Polman 2011].
- •3. Severe refractive errors defined as myopia or hypermetropia of ±6 diopters sphere or worse in either eye.
- •4. Loss of vision not due to AON.
- •5. Previous history of, or current severe disc edema or hemorrhage.
- •6. Abnormal FF-VEP in the fellow eye at Screening as determined by the central reader.
- •7. Concomitant ophthalmologic disorders (e.g., diabetic retinopathy, macular degeneration, macular exudate, macular edema, glaucoma, severe astigmatism, ocular trauma, neuromyelitis optica, ischemic optic neuropathy, congenital nystagmus) or other ophthalmologic conditions that could interfere with the proposed protocol as determined by a physician with expertise in the diagnosis and treatment of ophthalmologic disorders.
- •8. History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, oncologic, renal, severe allergic or anaphylactic reactions, or other major disease, as determined by the Investigator.
- •9. Females who have a positive pregnancy test result, or who are pregnant, breastfeeding, or planning to conceive during the study.
- •10. History of positive test result for human immunodeficiency virus (HIV).
- •11. History of hepatitis C virus antibody (HCV Ab) or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).
- •12. History or evidence of drug or alcohol abuse (as defined by the Investigator) within 2 years prior to Screening.
- •13. Current enrollment in any other study treatment or disease study within 3 months prior to Day 1/Baseline.
- •14. Participation in previous studies with BIIB033.
- •15. Inability to comply with study requirements.
- •16. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
研究者
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