Trial Outcomes & Findings for A Clinical Study to Evaluate CAD-1883 in Essential Tremor (NCT NCT03688685)

Last Updated: 2021-08-05

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Time of signed informed consent until 21 days after first treatment

Results posted on

2021-08-05

Participant milestones
Measure	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 CAD-1883: Treatment groups receiving twice-daily oral dosing of CAD-1883 for a treatment period of 14 days.
Overall Study STARTED	25
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	4

Withdrawal data not reported

A Clinical Study to Evaluate CAD-1883 in Essential Tremor

Baseline characteristics by cohort
Measure	Open-label Study of CAD-1883 n=25 Participants Open-label study designed to evaluate the safety, tolerability, and efficacy of CAD-1883 administered twice daily orally to adult subjects with ET CAD-1883: Treatment groups receiving twice-daily oral dosing of CAD-1883 for a treatment period of 14 days.
Age, Continuous	67 years STANDARD_DEVIATION 12.51 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

Timeframe: Time of signed informed consent until 21 days after first treatment

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

Outcome measures
Measure	Open-label Study of CAD-1883 n=25 Participants Open-label study designed to evaluate the safety, tolerability, and efficacy of CAD-1883 administered twice daily orally to adult subjects with ET CAD-1883: Treatment groups receiving twice-daily oral dosing of CAD-1883 for a treatment period of 14 days.
Evaluate the Occurrence and Severity of Treatment Emergent AEs. Subjects with at least 1 TAE	13 participants
Evaluate the Occurrence and Severity of Treatment Emergent AEs. Subjects with Mild AE	9 participants
Evaluate the Occurrence and Severity of Treatment Emergent AEs. Subjects with Moderate AE	2 participants
Evaluate the Occurrence and Severity of Treatment Emergent AEs. Subjects with Severe AE	2 participants

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Open-label Study of CAD-1883 n=25 participants at risk Open-label study designed to evaluate the safety, tolerability, and efficacy of CAD-1883 administered twice daily orally to adult subjects with ET CAD-1883: Treatment groups receiving twice-daily oral dosing of CAD-1883 for a treatment period of 14 days.
General disorders Fatigue	8.0% 2/25 • Number of events 2 • Adverse event data was collected from the time the subject signed the informed consent form until the Follow-Up Visit at Day 21.

Phone: 1-888-669-6682

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor must review results communications prior to public release and can embargo communications regarding trial results. At least sixty (60) days prior to submission for publication or presentation, Institution or Investigator shall submit in writing to sponsor for review or comment of any proposed oral or written publication. The sponsor can require changes to the communication and can delay the publication an additional sixty (60) days.
Publication restrictions are in place

Restriction type: OTHER