Spinocerebellar Ataxias Clinical Trial
— Synchrony-1Official title:
Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of CAD-1883 in Adults With Spinocerebellar Ataxia (Synchrony-1)
NCT number | NCT04301284 |
Other study ID # | CAD1883-211 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2021 |
Est. completion date | December 2022 |
Verified date | April 2021 |
Source | Cadent Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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). This study offers the opportunity to understand the safety, tolerability, and efficacy of CAD-1883 in the SCA patient population.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2022 |
Est. primary completion date | November 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Key Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado | Aurora | Colorado |
United States | University of Florida | Gainesville | Florida |
United States | Houston Methodist Research Institute | Houston | Texas |
United States | Collaborative Neuroscience Network | Long Beach | California |
United States | UCLA Medical Center | Los Angeles | California |
United States | University of South Florida: Ataxia Research Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Cadent Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the safety and tolerability of oral administration of CAD-1883 versus placebo: Incidence of Adverse Events | Incidence of Adverse Events | 12 week treatment period |
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