Trial Outcomes & Findings for A Study To Assess the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor (ET) (NCT NCT05122650)

Results Overview

The TETRAS composite outcome score is the sum of modified items 1 - 11 of the TETRAS-ADL subscale and modified items 6 - 7 of the TETRAS-PS. The TETRAS-ADL subscale is a patient-rated scale administered by a trained interviewer that assesses the impact of tremor on day-to-day functioning, such as eating, drinking, dressing, and other fine motor skills. The TETRAS-PS is a clinical rating scale that quantifies tremor in the head, face voice, limbs and trunk. Items 6 (drawing an Archimedes spiral using left and right hands) and 7 (handwriting) of the TETRAS-PS evaluate the impact of upper limb tremor on performance. Each item from the modified subscales ranges from 0 - 3, with 0 representing normal or slightly abnormal and 3 representing severely abnormal. The sum of the 14 items provides the TETRAS composite outcome score, which ranges from 0 - 42, with higher scores representing more severe ET.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

420 participants

Primary outcome timeframe

Change from baseline to week 12

Results posted on

2025-07-24

Participant Flow

A total of 420 participants were randomized to treatment. These 420 participants are included in the Intent to Treat Analysis set (ITT). Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. These 416 participants are included in the Safet Analysis Set

Participant milestones

Participant milestones
Measure	Placebo Participants will receive placebo from Day 1.	10 Milligram (mg) JZP385 Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.	20 mg JZP385 Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, and 20 mg/day starting on Day 15.	30 mg JZP385 Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, 20 mg/day from Day 15 through Day 21, and 30 mg/day starting on Day 22.
Overall Study STARTED	104	105	104	107
Overall Study COMPLETED	91	78	81	78
Overall Study NOT COMPLETED	13	27	23	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants will receive placebo from Day 1.	10 Milligram (mg) JZP385 Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.	20 mg JZP385 Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, and 20 mg/day starting on Day 15.	30 mg JZP385 Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, 20 mg/day from Day 15 through Day 21, and 30 mg/day starting on Day 22.
Overall Study Adverse Event	4	16	11	12
Overall Study Lack of Efficacy	0	1	1	2
Overall Study Lost to Follow-up	1	1	3	0
Overall Study Non-compliance with study intervention	0	0	0	2
Overall Study Protocol Violation	0	1	0	1
Overall Study Randomized by mistake	0	0	3	2
Overall Study Sponsor request	0	1	1	2
Overall Study Withdrawal by Subject	3	7	4	8
Overall Study Other	5	0	0	0

Baseline Characteristics

A Study To Assess the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor (ET)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=104 Participants Participants will receive placebo from Day 1.	10 Milligram (mg) JZP385 n=105 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.	20 mg JZP385 n=104 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, and 20 mg/day starting on Day 15.	30 mg JZP385 n=107 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, 20 mg/day from Day 15 through Day 21, and 30 mg/day starting on Day 22.	Total n=420 Participants Total of all reporting groups
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	9 Participants n=4 Participants	27 Participants n=21 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants	51 Participants n=7 Participants	45 Participants n=5 Participants	48 Participants n=4 Participants	187 Participants n=21 Participants
Age, Categorical >=65 years	61 Participants n=5 Participants	54 Participants n=7 Participants	59 Participants n=5 Participants	59 Participants n=4 Participants	233 Participants n=21 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	37 Participants n=7 Participants	33 Participants n=5 Participants	49 Participants n=4 Participants	160 Participants n=21 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	68 Participants n=7 Participants	71 Participants n=5 Participants	58 Participants n=4 Participants	260 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	11 Participants n=4 Participants	41 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	93 Participants n=5 Participants	95 Participants n=7 Participants	95 Participants n=5 Participants	96 Participants n=4 Participants	379 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants
Race (NIH/OMB) White	98 Participants n=5 Participants	96 Participants n=7 Participants	93 Participants n=5 Participants	92 Participants n=4 Participants	379 Participants n=21 Participants

PRIMARY outcome

Timeframe: Change from baseline to week 12

Population: The primary outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 TETRAS assessment.

The TETRAS composite outcome score is the sum of modified items 1 - 11 of the TETRAS-ADL subscale and modified items 6 - 7 of the TETRAS-PS. The TETRAS-ADL subscale is a patient-rated scale administered by a trained interviewer that assesses the impact of tremor on day-to-day functioning, such as eating, drinking, dressing, and other fine motor skills. The TETRAS-PS is a clinical rating scale that quantifies tremor in the head, face voice, limbs and trunk. Items 6 (drawing an Archimedes spiral using left and right hands) and 7 (handwriting) of the TETRAS-PS evaluate the impact of upper limb tremor on performance. Each item from the modified subscales ranges from 0 - 3, with 0 representing normal or slightly abnormal and 3 representing severely abnormal. The sum of the 14 items provides the TETRAS composite outcome score, which ranges from 0 - 42, with higher scores representing more severe ET.

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Participants will receive placebo from Day 1.	10 Milligram (mg) JZP385 n=79 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.	20 mg JZP385 n=82 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, and 20 mg/day starting on Day 15.	30 mg JZP385 n=78 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, 20 mg/day from Day 15 through Day 21, and 30 mg/day starting on Day 22.
Change From Baseline to Week 12 on the TETRAS Composite Outcome Score as Summarized by Each Dose of JZP385 and Placebo	-6.3 score on a scale Standard Deviation 6.22	-5.8 score on a scale Standard Deviation 6.85	-6.7 score on a scale Standard Deviation 6.88	-7.5 score on a scale Standard Deviation 7.31

SECONDARY outcome

Timeframe: Change from baseline to week 12

Population: Inferential analysis results were based on multiple imputations (impute missing values) on all study population

The CGI-S is a 5-point Likert-type rating scale that a qualified medical personnel (ie, a clinician)will use to rate the severity of the participants' ability to function due to their ET. The responses to this scale range from 1 (no limitations) to 5 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=104 Participants Participants will receive placebo from Day 1.	10 Milligram (mg) JZP385 n=105 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.	20 mg JZP385 n=104 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, and 20 mg/day starting on Day 15.	30 mg JZP385 n=107 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, 20 mg/day from Day 15 through Day 21, and 30 mg/day starting on Day 22.
Percentage of Participants Who Improved (≥ 1-Point Improvement) From Baseline to Week 12 on the Clinical Global Impression- Severity Scale (CGI-S)	50.0 Percentage of participants	49.8 Percentage of participants	55.7 Percentage of participants	62.8 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 CGI-C assessment.

The CGI-C is a 5-point Likert-type rating scale that a qualified medical personnel (ie, a clinician) will use to rate the change in severity of the participants' ability to function due to their ET since baseline. The responses to this scale range from 1 (Much improved) to 5 (Much worse).

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Participants will receive placebo from Day 1.	10 Milligram (mg) JZP385 n=79 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.	20 mg JZP385 n=82 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, and 20 mg/day starting on Day 15.	30 mg JZP385 n=79 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, 20 mg/day from Day 15 through Day 21, and 30 mg/day starting on Day 22.
Proportion of Participants Reported as Much Improved on the Clinical Global Impression of Change (CGI-C) at Week 12	22 Participants	18 Participants	19 Participants	30 Participants

SECONDARY outcome

Timeframe: Change from baseline to week 12

Population: The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 PGI-C assessment.

The PGI-C is a 5-point Likert-type rating scale that participants use to rate the change in severity of their ability to function due to ET since baseline. The responses to this scale range from 1 (Much improved) to 5 (Much worse).

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Participants will receive placebo from Day 1.	10 Milligram (mg) JZP385 n=79 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.	20 mg JZP385 n=82 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, and 20 mg/day starting on Day 15.	30 mg JZP385 n=79 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, 20 mg/day from Day 15 through Day 21, and 30 mg/day starting on Day 22.
Proportion of Participants Reported as Much Improved on the Patient Global Impression of Change (PGI-C) at Week 12	16 Participants	11 Participants	20 Participants	32 Participants

SECONDARY outcome

Timeframe: Change from baseline to week 12

Population: The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 TETRAS-ADL assessment.

The TETRAS-ADL subscale is a patient-rated scale of the impact of tremor on day-to-day functioning administered by a trained interviewer. The TETRAS-ADL subscale directly measures how a patient functions by assessing activities impacted by tremor, such as eating and drinking, dressing and personal hygiene, carrying items and fine motor skills. The TETRAS-ADL has 12 items, and each item is rated on a 0 (normal) to 4 (severe) scale with a total score ranging from 0 to 48. A higher score represents more severe ET.

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Participants will receive placebo from Day 1.	10 Milligram (mg) JZP385 n=79 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.	20 mg JZP385 n=82 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, and 20 mg/day starting on Day 15.	30 mg JZP385 n=79 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, 20 mg/day from Day 15 through Day 21, and 30 mg/day starting on Day 22.
Change From Baseline to Week 12 on the TETRAS-ADL Subscale as Summarized by Each Dose of JZP385 and Placebo	-6.4 score on a scale Standard Deviation 6.40	-6.3 score on a scale Standard Deviation 7.55	-7.1 score on a scale Standard Deviation 7.88	-8.7 score on a scale Standard Deviation 8.49

SECONDARY outcome

Timeframe: Change from baseline to week 12

Population: The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 TETRAS-PS subscale assessment.

The TETRAS-PS is a clinical rating scale performed by a blinded rater that quantifies tremor in the head, face, voice, limbs, and trunk. Each item will be rated on a scale of 0 (normal) to 4 (severe). The sum of the individual scores provides the overall score, ranging from 0 to 64, with higher scores representing more severe ET.

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Participants will receive placebo from Day 1.	10 Milligram (mg) JZP385 n=79 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.	20 mg JZP385 n=82 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, and 20 mg/day starting on Day 15.	30 mg JZP385 n=78 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, 20 mg/day from Day 15 through Day 21, and 30 mg/day starting on Day 22.
Change From Baseline to Week 12 on the TETRAS-PS Subscale as Summarized by Each Dose of JZP385 and Placebo	-5.4 score on a scale Standard Deviation 5.73	-5.3 score on a scale Standard Deviation 6.57	-5.1 score on a scale Standard Deviation 6.15	-5.5 score on a scale Standard Deviation 6.27

SECONDARY outcome

Timeframe: Change from baseline to week 12

Population: The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 Upper limb score on the TETRAS-PS assessment.

Item 4 of the TETRAS-PS measures upper limb tremor, and includes 3 maneuvers for each arm that assess postural and kinetic tremor. Each item is rated on a scale of 0 (normal) to 4 (severe) in 0.5-point increments. The total score is the sum of each of the 6 items and ranges from 0 to 24, with higher scores representing more severe ET. The TETRAS-PS is performed by a blinded rater.

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Participants will receive placebo from Day 1.	10 Milligram (mg) JZP385 n=79 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.	20 mg JZP385 n=82 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, and 20 mg/day starting on Day 15.	30 mg JZP385 n=78 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, 20 mg/day from Day 15 through Day 21, and 30 mg/day starting on Day 22.
Change From Baseline to Week 12 on the Upper Limb Score (Item 4) of the TETRAS-PS as Summarized by Each Dose of JZP385 and Placebo	-2.3 score on a scale Standard Deviation 2.68	-2.4 score on a scale Standard Deviation 2.78	-2.0 score on a scale Standard Deviation 2.61	-2.4 score on a scale Standard Deviation 2.81

SECONDARY outcome

Timeframe: Change from baseline to week 12

Population: The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 TETRAS Total assessment.

The TETRAS total score is the sum of the scores of the full TETRAS-ADL and TETRAS-PS subscales. Each item is rated on a 0 (normal) to 4 (severe) scale, and total scores range from 0 to 112, with higher scores representing more severe ET. The TETRAS-PS is performed by a blinded rater.

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Participants will receive placebo from Day 1.	10 Milligram (mg) JZP385 n=79 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.	20 mg JZP385 n=82 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, and 20 mg/day starting on Day 15.	30 mg JZP385 n=78 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, 20 mg/day from Day 15 through Day 21, and 30 mg/day starting on Day 22.
Change From Baseline to Week 12 on the TETRAS Total Score, as Summarized by Each Dose of JZP385 and Placebo.	-11.8 score on a scale Standard Deviation 10.18	-11.6 score on a scale Standard Deviation 11.54	-12.3 score on a scale Standard Deviation 11.95	-14.4 score on a scale Standard Deviation 12.20

SECONDARY outcome

Timeframe: Change from baseline to week 12

Population: The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 QUEST assessment.

The Quality of Life in Essential Tremor Questionnaire (QUEST) was developed to specifically assess the impact of ET on health-related quality of life. The QUEST is a 30-item questionnaire comprising 5 subscales (physical, psychosocial, communication, hobbies/leisure, and work/finance). Each item is rated by frequency on a scale from 0 (never) to 4 (always). Each dimension had been standardized to a range of 0 to 100 with higher scores indicating greater dissatisfaction or disability due to ET.

Outcome measures

Outcome measures
Measure	Placebo n=99 Participants Participants will receive placebo from Day 1.	10 Milligram (mg) JZP385 n=100 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.	20 mg JZP385 n=95 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, and 20 mg/day starting on Day 15.	30 mg JZP385 n=98 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, 20 mg/day from Day 15 through Day 21, and 30 mg/day starting on Day 22.
Change From Baseline to Week 12 on the Quality of Life in Essential Tremor Questionnaire (QUEST) as Summarized by Each Dose of JZP385 and Placebo Communication Subscale Total Score	-5.5 score on a scale Standard Deviation 15.35	-3.3 score on a scale Standard Deviation 15.62	-3.5 score on a scale Standard Deviation 14.67	-7.8 score on a scale Standard Deviation 16.18
Change From Baseline to Week 12 on the Quality of Life in Essential Tremor Questionnaire (QUEST) as Summarized by Each Dose of JZP385 and Placebo Work and Finance Subscale Total Score	-5.8 score on a scale Standard Deviation 16.44	1.0 score on a scale Standard Deviation 17.26	-6.1 score on a scale Standard Deviation 15.61	-6.7 score on a scale Standard Deviation 15.11
Change From Baseline to Week 12 on the Quality of Life in Essential Tremor Questionnaire (QUEST) as Summarized by Each Dose of JZP385 and Placebo Hobbies and Leisure Subscale Total Score	-1.1 score on a scale Standard Deviation 29.35	-8.9 score on a scale Standard Deviation 31.66	-3.5 score on a scale Standard Deviation 36.50	-10.2 score on a scale Standard Deviation 33.81
Change From Baseline to Week 12 on the Quality of Life in Essential Tremor Questionnaire (QUEST) as Summarized by Each Dose of JZP385 and Placebo Physical Subscale Total Score	-11.0 score on a scale Standard Deviation 17.65	-5.1 score on a scale Standard Deviation 17.60	-10.1 score on a scale Standard Deviation 16.85	-13.4 score on a scale Standard Deviation 20.24
Change From Baseline to Week 12 on the Quality of Life in Essential Tremor Questionnaire (QUEST) as Summarized by Each Dose of JZP385 and Placebo Psychosocial Subscale Total Score	-6.8 score on a scale Standard Deviation 14.93	-2.9 score on a scale Standard Deviation 16.57	-6.1 score on a scale Standard Deviation 15.79	-6.2 score on a scale Standard Deviation 15.40

SECONDARY outcome

Timeframe: Change from baseline to week 12

Population: The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 ETEA assessment.

The Essential Tremor Embarrassment Assessment (ETEA) is a participant-rated questionnaire administered by a health care provider or researcher that contains 14-items assessing embarrassment related to tremor. For Score A, participants provide a simple response (disagree or agree) to each of the 14-items, the sum of which yields an initial score range = 0 to 14. Higher scores indicate greater embarrassment

Outcome measures

Outcome measures
Measure	Placebo n=98 Participants Participants will receive placebo from Day 1.	10 Milligram (mg) JZP385 n=99 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.	20 mg JZP385 n=95 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, and 20 mg/day starting on Day 15.	30 mg JZP385 n=97 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, 20 mg/day from Day 15 through Day 21, and 30 mg/day starting on Day 22.
Change From Baseline to Week 12 on the Essential Tremor Embarrassment Assessment (ETEA) Score A as Summarized by Each Dose of JZP385 and Placebo	-0.6 score on a scale Standard Deviation 2.84	-0.5 score on a scale Standard Deviation 3.06	-0.6 score on a scale Standard Deviation 3.60	-1.2 score on a scale Standard Deviation 3.51

SECONDARY outcome

Timeframe: Change from baseline to week 12

Population: The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 ETEA assessment.

The Essential Tremor Embarrassment Assessment (ETEA) is a participant-rated questionnaire administered by a health care provider or researcher that contains 14-items assessing embarrassment related to tremor. For Score B, participants provide a more nuanced response to each question on a 0 to 5 point Likert scale ranging from disagree (0) to agree strongly (5). The sum of the nuanced responses yields a second score (range = 0 to 70). Higher scores indicate greater embarrassment

Outcome measures

Outcome measures
Measure	Placebo n=98 Participants Participants will receive placebo from Day 1.	10 Milligram (mg) JZP385 n=99 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.	20 mg JZP385 n=95 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, and 20 mg/day starting on Day 15.	30 mg JZP385 n=97 Participants Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, 20 mg/day from Day 15 through Day 21, and 30 mg/day starting on Day 22.
Change From Baseline to Week 12 on the Essential Tremor Embarrassment Assessment (ETEA) Score B as Summarized by Each Dose of JZP385 and Placebo	-4.2 score on a scale Standard Deviation 12.87	-3.5 score on a scale Standard Deviation 14.15	-4.6 score on a scale Standard Deviation 14.42	-5.6 score on a scale Standard Deviation 14.28

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 20 other events

Deaths: 1 deaths

10 Milligram (mg) JZP385

Serious events: 3 serious events

Other events: 35 other events

Deaths: 0 deaths

20 mg JZP385

Serious events: 4 serious events

Other events: 35 other events

Deaths: 0 deaths

30 mg JZP385

Serious events: 4 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=104 participants at risk Participants will receive placebo from Day 1.	10 Milligram (mg) JZP385 n=104 participants at risk Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.	20 mg JZP385 n=103 participants at risk Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, and 20 mg/day starting on Day 15.	30 mg JZP385 n=105 participants at risk Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, 20 mg/day from Day 15 through Day 21, and 30 mg/day starting on Day 22.
Gastrointestinal disorders Diarrhoea	0.96% 1/104 • Number of events 1 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	5.8% 6/104 • Number of events 6 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	3.9% 4/103 • Number of events 5 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	4.8% 5/105 • Number of events 5 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Dry mouth	0.96% 1/104 • Number of events 1 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	5.8% 6/104 • Number of events 6 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	0.97% 1/103 • Number of events 1 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	4.8% 5/105 • Number of events 5 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Nausea	0.96% 1/104 • Number of events 2 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	5.8% 6/104 • Number of events 6 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	2.9% 3/103 • Number of events 3 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	3.8% 4/105 • Number of events 4 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.
General disorders Fatigue	0.96% 1/104 • Number of events 1 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	3.8% 4/104 • Number of events 4 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	2.9% 3/103 • Number of events 3 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	6.7% 7/105 • Number of events 7 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.
Infections and infestations Nasopharyngitis	4.8% 5/104 • Number of events 5 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	5.8% 6/104 • Number of events 6 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	0.00% 0/103 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	3.8% 4/105 • Number of events 5 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.
Nervous system disorders Disturbance in attention	0.00% 0/104 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	1.9% 2/104 • Number of events 2 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	5.8% 6/103 • Number of events 6 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	3.8% 4/105 • Number of events 4 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.
Nervous system disorders Dizziness	6.7% 7/104 • Number of events 9 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	10.6% 11/104 • Number of events 12 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	10.7% 11/103 • Number of events 14 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	11.4% 12/105 • Number of events 15 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.
Nervous system disorders Headache	4.8% 5/104 • Number of events 5 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	7.7% 8/104 • Number of events 8 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	2.9% 3/103 • Number of events 3 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	4.8% 5/105 • Number of events 5 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.
Nervous system disorders Paraesthesia	0.00% 0/104 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	0.96% 1/104 • Number of events 1 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	5.8% 6/103 • Number of events 6 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	8.6% 9/105 • Number of events 10 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.
Nervous system disorders Somnolence	3.8% 4/104 • Number of events 4 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	1.9% 2/104 • Number of events 2 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	4.9% 5/103 • Number of events 6 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	6.7% 7/105 • Number of events 8 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.
Nervous system disorders Tremor	1.9% 2/104 • Number of events 2 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	0.96% 1/104 • Number of events 3 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	2.9% 3/103 • Number of events 3 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	6.7% 7/105 • Number of events 7 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.
Psychiatric disorders Anxiety	0.00% 0/104 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	5.8% 6/104 • Number of events 6 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	1.9% 2/103 • Number of events 2 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	2.9% 3/105 • Number of events 3 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.
Psychiatric disorders Insomnia	1.9% 2/104 • Number of events 2 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	4.8% 5/104 • Number of events 5 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	2.9% 3/103 • Number of events 3 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.	6.7% 7/105 • Number of events 7 • Up to 14 weeks A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.

Additional Information

Clinical Trial Disclosure & Transparency

Jazz Pharmaceuticals

Phone: 215-832-3750

Email: [email protected]

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Principal investigator is a sponsor employee
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