TerminatedNot Applicable

Study of Disease Progression in Adults With Inherited Forms of Spastic Paraplegia

Stopped: The AMN program requires significantly more time, patients, and resources, including the manufacture of additional investigational product, than what is currently available to Spur.

United States, Germany65 participantsStarted 2021-06-21

Plain-language summary

The course of AMN-related disabilities over time is poorly or incompletely understood due to a limited number of patients and lack of treatments. This study will help obtain a better understanding of the progression of disease with AMN and facilitate efficient clinical development of future interventional medications.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. Male adults aged ≥18 years
✓. Diagnosed with ALD based on elevated VLCFA assay and pedigree analysis
✓. Clinical evidence of spinal cord involvement with EDSS score between 1 and 6.5

Exclusion criteria

✕. Diagnosed with cerebral inflammatory disease or has a history of diagnosis with cerebral inflammatory disease
✕. 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
✕. 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

What they're measuring

Disease progression

Timeframe: 5 years

Trial details

NCT IDNCT05008874

SponsorSwanBio Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-05-16

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