Ignite Creation Date:
2024-05-06 @ 2:23 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04301284
Status:
WITHDRAWN
Last Update Posted:
2021-04-08
First Post:
2020-03-06
Brief Title:
Study of CAD-1883 for Spinocerebellar Ataxia
Sponsor:
Cadent Therapeutics
Organization:
Cadent Therapeutics
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
In January 2021 Novartis acquired Cadent Therapeutics As part of a pipeline reassessment the Synchrony-1 trial will not proceed as initially scheduled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Synchrony-1
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 This study offers the opportunity to understand the safety tolerability and efficacy of CAD-1883 in the SCA patient population
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 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 clinicianpatient 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
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 clinicianpatient 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None