NL-OMON54146已完成不适用
Prospective, Retrospective, Multicenter, Observational Study of Disease Progression in Adults with Inherited Forms of Spastic Paraplegia - Not applicable
SwanBio Therapeutics, Ltd0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Male adults aged >=18 years
- •2. Diagnosed with ALD based on elevated VLCFA assay and pedigree analysis
- •3. Clinical evidence of spinal cord involvement with EDSS score between 1 and
- •6.5. The number of patients with normal pyramidal function on the Functional
- •System Score (FSS) of the EDSS scale, or EDSS >=5.5 will be limited to 10 (ten)
- •for each criterion.
- •4. The participant provided written informed consent prior to any study
- •procedures being performed
排除标准
- •1. Diagnosed with cerebral inflammatory disease. Cerebral inflammatory disease
- •is diagnosed with the presence of inflammatory (Gadolinium-enhancing) lesion(s)
- •on a brain MRI.
- •Note: Absence of cerebral inflammatory disease will be confirmed at Visit 1
- •with review of a MRI scan or report performed within 12 months prior to the
- •Baseline Visit.
- •2. In AMN participants, pathological changes identified on a brain MRI except
- •for the abnormalities that can be observed in AMN participants.
- •3. Any conditions that make it impossible to perform MRI studies (including
- •allergy to Gadolinium or contrast agents).
- •4. Unstable, clinically significant neurologic (other than the disease being
- •studied), psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic,
- •renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or
- •endocrine disease (other than adrenal insufficiency) or other abnormality,
- •which may impact the ability to participate in the study or that may
- •potentially confound the study results. It is the responsibility of the
- •Investigator to assess the clinical significance; however, consultation with
- •the Medical Monitor may be warranted.
- •5. Participant who, in the opinion of the Investigator, has any other medical
- •or psychological condition or social circumstances which would impair their
- •ability to participate reliably in the assessments, or who may increase the
- •risk to themselves or others by participating.
- •6. The participant is employed by SwanBio Therapeutics, Contract Research
- •Organization (CRO), or trial site (permanent, temporary contract worker, or
- •designee responsible for the conduct of the study) or is an immediate family
- •(e.g. spouse, parent, child, sibling) member of a SwanBio Therapeutics, CRO, or
- •trial site employee.
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