Status:
WITHDRAWN
Study of CAD-1883 for Spinocerebellar Ataxia
Lead Sponsor:
Cadent Therapeutics
Conditions:
Spinocerebellar Ataxias
Spinocerebellar Ataxia Type 1
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a randomized, double-blind, placebo-controlled Phase 2 study evaluating oral administration of CAD-1883 in the treatment of adults with a genotypic diagnosis of Spinocerebellar Ataxia (SCA). T...
Detailed Description
This is a randomized, double-blind, placebo-controlled Phase 2 study evaluating oral administration of CAD-1883 in the treatment of adults with a genotypic diagnosis of SCA using multiple dose levels....
Eligibility Criteria
Inclusion
- Key
- Prior Spinocerebellar Ataxia (SCA) diagnosis of the following SCA genotypes: SCA1, 2, 3, 6, 7, 8, 10, 17, or Autosomal Recessive Cerebellar Ataxia Type 1 (ARCA1).
- Scale for the Assessment and Rating of Ataxia (SARA) Total score ≥8 and \<30 at Screening
- SARA item #1 (gait) score of ≥2 at Screening
- Ability to ambulate 8 meters at Screening without assistance from another person
- Key
Exclusion
- Neurological condition other than SCA that could predominantly explain or contribute significantly to the subjects' symptoms of ataxia or that could confound the assessment of ataxia symptoms (e.g., chronic alcoholism, vitamin deficiencies, multiple sclerosis, Parkinson's disease, Friedreich's ataxia, vascular disease, tumors, paraneoplastic disease, head injury, idiopathic late onset ataxia, multisystem atrophy, stroke, arthritis, cerebral palsy, spasticity of unknown origin).
- Moderate or severe scores on the following Inventory of Non-Ataxia Signs (INAS) items at Screening: Dystonia: at least 3 of 5 items; Spasticity: at least 2 of 3 items; Rigidity: at least 2 of 3 items
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04301284
Start Date
June 1 2021
End Date
December 1 2022
Last Update
April 8 2021
Active Locations (6)
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1
Collaborative Neuroscience Network
Long Beach, California, United States, 90806
2
UCLA Medical Center
Los Angeles, California, United States, 90095
3
University of Colorado
Aurora, Colorado, United States, 80045
4
University of Florida
Gainesville, Florida, United States, 32608