Study of CAD-1883 for Spinocerebellar Ataxia (Synchrony-1)
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|ClinicalTrials.gov Identifier: NCT04301284|
Recruitment Status : Withdrawn (In January 2021 Novartis acquired Cadent Therapeutics. As part of a pipeline reassessment, the Synchrony-1 trial will not proceed as initially scheduled.)
First Posted : March 10, 2020
Last Update Posted : April 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Spinocerebellar Ataxias Spinocerebellar Ataxia Type 1 Spinocerebellar Ataxia Type 2 Spinocerebellar Ataxia Type 3 Spinocerebellar Ataxia Type 6 Spinocerebellar Ataxia Type 7 Spinocerebellar Ataxia Type 8 Spinocerebellar Ataxia Type 10 Spinocerebellar Ataxia Type 17 ARCA1 - Autosomal Recessive Cerebellar Ataxia Type 1||Drug: CAD-1883 Drug: Placebos||Phase 2|
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. The study will include multiple cohorts of 16 patients each where 12 patients will be randomized to CAD-1883 and 4 to matching placebo.
Potential subjects will undergo a screening period (14 to 28 days), a baseline (Day 1) visit, and a 12-week treatment period. A follow-up visit will occur 4 weeks after the end of the treatment period. The total duration of individual subject participation may be up to 20 weeks, depending on the duration of the screening period.
The study will assess safety by adverse events, vital signs, laboratory parameters (including chemistry, hematology and urinalysis); pharmacokinetics of CAD-1883; and efficacy measures by Scale for the Assessment and Rating of Ataxia (SARA), clinician/patient rating of ataxia and symptoms, patient quality of life measures and wearable sensors to capture falls and gait measurements.
For planning purposes, the anticipated study completion date assumes evaluation of 3 cohorts.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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)|
|Estimated Study Start Date :||June 2021|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||December 2022|
Capsules of 150 mg of CAD-1883 will be administered orally, twice daily (BID). The second daily dose will be taken 8 hours (+/- 2 hours) after the first daily dose.
The initial dose regimen evaluated will be 150 mg BID. Additional dose regimens up to 600 mg BID will be determined based on forthcoming clinical data.
150 mg filled capsules
Placebo Comparator: Placebo
Matching placebo will be provided in capsules, to be administered orally, twice daily. The second daily dose will be taken 8 hours (+/- 2 hours) after the first daily dose.
- To evaluate the safety and tolerability of oral administration of CAD-1883 versus placebo: Incidence of Adverse Events [ Time Frame: 12 week treatment period ]Incidence of Adverse Events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04301284
|United States, California|
|Collaborative Neuroscience Network|
|Long Beach, California, United States, 90806|
|UCLA Medical Center|
|Los Angeles, California, United States, 90095|
|United States, Colorado|
|University of Colorado|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32608|
|University of South Florida: Ataxia Research Center|
|Tampa, Florida, United States, 33612|
|United States, Texas|
|Houston Methodist Research Institute|
|Houston, Texas, United States, 77030|