NL-OMON54146
Completed
Not Applicable
Prospective, Retrospective, Multicenter, Observational Study of Disease Progression in Adults with Inherited Forms of Spastic Paraplegia - Not applicable
SwanBio Therapeutics, Ltd0 sites20 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spastic paraplegia / adrenomyeloneuropathy
- Sponsor
- SwanBio Therapeutics, Ltd
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Not specified
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