Ignite Creation Date:
2024-05-06 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03688685
Status:
COMPLETED
Last Update Posted:
2021-08-05
First Post:
2018-09-26
Brief Title:
A Clinical Study to Evaluate CAD-1883 in Essential Tremor
Sponsor:
Cadent Therapeutics
Organization:
Cadent Therapeutics
Study Overview
Official Title:
A Phase 2a Open-Label Study to Evaluate the Safety Tolerability and Efficacy of CAD-1883 Oral Treatment in Adults With Essential Tremor
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label study designed to evaluate the safety tolerability and efficacy of CAD-1883 a positive allosteric modulator of the SK channel administered twice daily orally to adult patients with ET Patients with the diagnosis of ET based on the Movement Disorder Society MDS criteria with a documented severity of tremor based on the clinician-administered TETRAS Performance Subscale are eligible to be enrolled in the study
Detailed Description:
This is an open-label study designed to evaluate the safety tolerability and efficacy of CAD-1883 a positive allosteric modulator PAM of the SK channel administered twice daily orally to adult subjects with ET Positive modulation of the small-conductance calcium-activated potassium channels SK present in different regions of the brain aims to increase the channel sensitivity to calcium resulting in reduction in neuronal firing rate In patients with ET improving the regularity of firing of action potentials in the olivo-cerebellar network can lead to improvement in motor function
During the Screening period each subject will undergo full assessment including medical and treatment history for ET physical examination and other screening assessments Patients with the diagnosis of ET based on the Movement Disorder Society MDS criteria with a documented severity of tremor based on the clinician-administered TETRAS Performance Subscale are eligible to be enrolled in the study The study consists of treatment groups receiving twice daily oral dosing of CAD-1883 for a treatment period of 14 days
This study is designed to enable the assessment of safety and tolerability of CAD-1883 in patients with ET as well as the determination of early treatment effect on reducing the magnitude and severity of tremor while limiting the potential risk associated with a novel investigational drug
Safety and tolerability will be monitored throughout the study duration including in-clinic assessments of adverse events AEs serious adverse events SAEs vital signs 12-lead ECG urinalysis hematology clinical chemistry and CAD-1883 plasma concentration level on Days 1 7 14 and 21
Efficacy will be evaluated using the clinician-administered TETRAS Performance Subscale as well as the use of a wearable sensor in the clinic and at home
During the Screening period each subject will undergo full assessment including medical and treatment history for ET physical examination and other screening assessments Patients with the diagnosis of ET based on the Movement Disorder Society MDS criteria with a documented severity of tremor based on the clinician-administered TETRAS Performance Subscale are eligible to be enrolled in the study The study consists of treatment groups receiving twice daily oral dosing of CAD-1883 for a treatment period of 14 days
This study is designed to enable the assessment of safety and tolerability of CAD-1883 in patients with ET as well as the determination of early treatment effect on reducing the magnitude and severity of tremor while limiting the potential risk associated with a novel investigational drug
Safety and tolerability will be monitored throughout the study duration including in-clinic assessments of adverse events AEs serious adverse events SAEs vital signs 12-lead ECG urinalysis hematology clinical chemistry and CAD-1883 plasma concentration level on Days 1 7 14 and 21
Efficacy will be evaluated using the clinician-administered TETRAS Performance Subscale as well as the use of a wearable sensor in the clinic and at home
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?:
False
Is an FDA AA801 Violation?:
None