NCT03688685

A Clinical Study to Evaluate CAD-1883 in Essential Tremor

Completed Phase 2 Results posted Last updated 5 August 2021

What this trial tests

Phase 2 trial testing CAD-1883 in Essential Tremor in 25 participants. Completed in 24 September 2019.

Timeline

23 January 2019

Primary endpoint
10 September 2019

24 September 2019

Quick facts

Lead sponsor	Cadent Therapeutics
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	23 January 2019
Primary completion	10 September 2019
Estimated completion	24 September 2019
Sites	7 locations across United States

Drugs / interventions tested

• CAD-1883 — full drug profile →

Conditions studied

• Essential Tremor — all drugs for Essential Tremor →

Sponsor

Cadent Therapeutics — full company profile →

Who can join

Adults 18 to 75, any sex, with Essential Tremor. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Evaluate the Occurrence and Severity of Treatment Emergent AEs. Primary · Time of signed informed consent until 21 days after first treatment

Number of subjects who experienced TEAEs and the severity of those TEAEs.

Subjects with at least 1 TAE

Group	Value	95% CI
Open-label Study of CAD-1883	13

Subjects with Mild AE

Group	Value	95% CI
Open-label Study of CAD-1883	9

Subjects with Moderate AE

Group	Value	95% CI
Open-label Study of CAD-1883	2

Subjects with Severe AE

Group	Value	95% CI
Open-label Study of CAD-1883	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected from the time the subject signed the informed consent form until the Follow-Up Visit at Day 21.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Open-label Study of CAD-1883

Serious: 0/25 (0%)

Deaths: 0/25

Other adverse events (1 terms — click to expand)

Reaction	System	Open-label Study of CAD-1883
Fatigue	General disorders	—

Data from ClinicalTrials.gov NCT03688685 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Reduction of neuronal hyperexcitability with modulation of T-type calcium channel or SK channel in essential tremor.
   Wagle Shukla A. · · 2022 · cited 9× · PMID 35750369 · DOI 10.1016/bs.irn.2022.02.008
2. Therapeutic Strategies for Spinocerebellar Ataxia Type 1.
   Kerkhof LMC, van de Warrenburg BPC, van Roon-Mom WMC, Buijsen RAM. · · 2023 · cited 6× · PMID 37238658 · DOI 10.3390/biom13050788
3. Structural mechanisms for inhibition and activation of human small-conductance Ca<sup>2+</sup>-activated potassium channel SK2.
   Ma B, Wu D, Cao E, Chi C, et al · · 2026 · PMID 41540047 · DOI 10.1038/s41467-026-68475-4
4. Structural basis for the subtype-selectivity of K<sub>Ca</sub>2.2 channel activators.
   Nam YW, Ramanishka A, Xu Y, Yasuda RMH, et al · · 2026 · PMID 41507196 · DOI 10.1038/s41467-025-67232-3