A Clinical Study to Evaluate CAD-1883 in Essential Tremor
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|ClinicalTrials.gov Identifier: NCT03688685|
Recruitment Status : Not yet recruiting
First Posted : September 28, 2018
Last Update Posted : October 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Essential Tremor||Drug: CAD-1883||Phase 2|
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 1 open label treatment group receiving twice daily oral dosing of CAD-1883 for a treatment period of 14 days. The second daily dose will be taken 8 hours (±1 hour) after the first daily dose.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||November 2018|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||May 2019|
Experimental: Open-label study of CAD-1883
Open-label study designed to evaluate the safety, tolerability, and efficacy of CAD-1883 administered twice daily orally to adult subjects with ET
1 treatment group receiving twice-daily oral dosing of CAD-1883 for a treatment period of 14 days, with the second daily dose to be taken 8 hours (± 1 hour) after the first daily dose
- Evaluate the occurrence and severity of treatment emergent AEs. [ Time Frame: 21 days after first treatment ]Evaluate the occurrence and severity of treatment emergent AEs.
- Evaluate the occurrence and severity of treatment emergent AEs. [ Time Frame: 7 days after the last treatment ]Evaluate the occurrence and severity of treatment emergent AEs.
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): NCT03688685
|Contact: Bob Dagher, MDfirstname.lastname@example.org|