A Study To Assess the Safety and Efficacy of JZP385 in th... | NCT05122650

ID	Type	Description	Link
2020-002463-61	EudraCT Number

Label	Type	Description	Intervention Names
10 milligram (mg) JZP385	Experimental	Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.	Drug: JZP385
20 mg JZP385	Experimental	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.	Drug: JZP385
30 mg JZP385	Experimental	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.	Drug: JZP385
Placebo	Placebo Comparator	Participants will receive placebo from Day 1.	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
JZP385	Drug	JZP385 capsules will be administered orally (PO) once daily in the morning on an empty stomach for 12 weeks.	10 milligram (mg) JZP385 20 mg JZP385

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline to Week 12 on the TETRAS Composite Outcome Score as Summarized by Each Dose of JZP385 and Placebo	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.	Change from baseline to week 12

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Improved (≥ 1-Point Improvement) From Baseline to Week 12 on the Clinical Global Impression- Severity Scale (CGI-S)	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).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent.
Participants who are diagnosed with ET (including ET plus) according to the MDS Consensus Statement on the Classification of Tremors from the Task Force on Tremor of the International Parkinson's and Movement Disorder Society.
Participants have moderate to severe disability associated with tremor as determined by a score of ≥ 22 on the TETRAS-ADL subscale and a CGI-S rating of at least moderate for participants' ability to function.
Sex and Contraceptive/Barrier Requirements

During the study intervention and for at least 30 days after the last dose of study intervention male participants must refrain from donating sperm. Non-abstinent males must agree to use a male condom in combination with female partner use of a highly effective contraceptive method with a failure rate of < 1% per year. All male participants must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person.

Female participants must not be pregnant or breastfeeding, are either women of non-childbearing potential (WONCBP), or are women of childbearing potential (WOCBP) using a highly effective contraceptive method with a failure rate of < 1% during the study intervention period and for at least 30 days after the last dose of study intervention. Male partners of WOCBP are required to use barrier protection, eg, condoms, from the first dose of study intervention until 30 days after the last dose of study intervention.

A WOCBP must have a negative highly sensitive serum pregnancy test at Screening Visit 1 and negative urine pregnancy tests (unless serum is required by local regulations) at the Screening Visit 2 (if applicable) and at the Baseline Visit

- If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
Prior/Concomitant Antitremor Medications

If currently treated with antitremor medications, potential participants must be on a stable dosage for at least 6 weeks prior to Screening and must not anticipate making any changes to their antitremor medication for the duration of the study. Note: Treatment with some antitremor medications (eg, primidone) is not allowed in accordance with other exclusion criteria.

Exclusion Criteria:

Known history or current evidence of other medical or neurological conditions that may cause or explain the participant's tremor.
Has evidence at Screening of severe cognitive impairment as defined by a Montreal Cognitive Assessment (MoCA; score < 20) or has cognitive impairment that in the opinion of the investigator would prevent completion of study procedures (including the ability to accurately self-report on study questionnaires) or the ability to provide informed consent.
Current suicidal risk as determined from history, by presence of active suicidal ideation as indicated by positive response to item 4 or 5 on the C-SSRS (within the past 24 months), or any history of suicide attempt; current or past (within 1 year) major depressive episode according to DSM-5 criteria.
History (within past 2 years at screening) or presence of a diagnosed substance use disorder (including alcohol, tobacco, and cannabis) according to DSM-5 criteria, known drug dependence, or seeking treatment for alcohol or substance abuse related disorder.
Prior magnetic resonance (MR)-guided focused ultrasound thalamotomy, surgical intervention (eg, deep brain stimulation, ablative thalamotomy, gamma knife thalamotomy), or inability to refrain from using a device for treatment of tremor for the duration of the treatment period.
Botulinum toxin injection for the treatment of upper limb tremor in the 6 months before screening or planned use at any time during the study.
Treatment with any medication that could produce tremor taken within 2 weeks or 5 half-lives (whichever is longer) before screening or anticipated use at any time during participation in the study.
Use of prescription of nonprescription drugs or other products known to be inducers of CYP3A4 that are known to decrease AUC by > 30% (eg, primidone) and which cannot be discontinued at least 4 weeks before Baseline or planned use at any time during the study.
Use of prescription or nonprescription drugs, or other products (eg, grapefruit, grapefruit juice, or Seville oranges) known to be strong or moderate inhibitors of CYP3A4, that cannot be discontinued 2 weeks or 5 half-lives, whichever is longer, before Baseline or planned use at any time during the study.
Use of proton pump inhibitors that cannot be discontinued at least 2 weeks before Baseline, or planned use at any time during the study. Occasional use of antacids or histamine-2 receptor antagonists will be permitted, but antacids should be taken at least 4 hours before or after study intervention; and histamine-2 receptor antagonists should be taken at least 4 hours after and at least 12 hours before study intervention.
Inability to refrain from use of medication/substance(s) that might produce tremor or interfere with the evaluation of tremor on study visit days prior to discharge such as, but not limited to, stimulant decongestants, beta-agonist bronchodilators, and alcohol.
Regular use of more than 3 units of alcohol per day.
Regular consumption of caffeine > 400 mg/day or > 4 cups of coffee per day

Facility	Status	City	State	ZIP	Country	Contacts
The University Of Alabama At Birmingham (Uab)		Birmingham	Alabama	35233	United States
St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants will receive placebo from Day 1.
FG001	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 10, 2023	May 27, 2025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline to Week 12 on the TETRAS Composite Outcome Score as Summarized by Each Dose of JZP385 and Placebo

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.

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.

Posted

Mean

Standard Deviation

score on a scale

Change from baseline to week 12

ID	Title	Description
OG000	Placebo	Participants will receive placebo from Day 1.
OG001	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.
OG002	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.
OG003	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.

Units	Counts
Participants	OG00094 OG00179 OG00282 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-6.3± 6.22 OG001-5.8± 6.85 OG002-6.7± 6.88 OG003

Secondary

Percentage of Participants Who Improved (≥ 1-Point Improvement) From Baseline to Week 12 on the Clinical Global Impression- Severity Scale (CGI-S)

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).

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

Posted

Number

Percentage of participants

Change from baseline to week 12

ID	Title	Description
OG000	Placebo	Participants will receive placebo from Day 1.
OG001	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.
OG002	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.
OG003	30 mg JZP385

Secondary

Proportion of Participants Reported as Much Improved on the Clinical Global Impression of Change (CGI-C) at Week 12

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).

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.

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	Placebo	Participants will receive placebo from Day 1.
OG001	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.
OG002	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.
OG003	30 mg JZP385

Secondary

Proportion of Participants Reported as Much Improved on the Patient Global Impression of Change (PGI-C) at Week 12

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).

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.

Posted

Count of Participants

Participants

Change from baseline to week 12

ID	Title	Description
OG000	Placebo	Participants will receive placebo from Day 1.
OG001	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.
OG002	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.
OG003	30 mg JZP385

Secondary

Change From Baseline to Week 12 on the TETRAS-ADL Subscale as Summarized by Each Dose of JZP385 and Placebo

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.

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.

Posted

Mean

Standard Deviation

score on a scale

Change from baseline to week 12

ID	Title	Description
OG000	Placebo	Participants will receive placebo from Day 1.
OG001	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.
OG002	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.

Secondary

Change From Baseline to Week 12 on the TETRAS-PS Subscale as Summarized by Each Dose of JZP385 and Placebo

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.

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.

Posted

Mean

Standard Deviation

score on a scale

Change from baseline to week 12

ID	Title	Description
OG000	Placebo	Participants will receive placebo from Day 1.
OG001	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.
OG002	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.
OG003

Secondary

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

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.

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.

Posted

Mean

Standard Deviation

score on a scale

Change from baseline to week 12

ID	Title	Description
OG000	Placebo	Participants will receive placebo from Day 1.
OG001	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.
OG002	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.

Secondary

Change From Baseline to Week 12 on the TETRAS Total Score, as Summarized by Each Dose of JZP385 and Placebo.

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.

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.

Posted

Mean

Standard Deviation

score on a scale

Change from baseline to week 12

ID	Title	Description
OG000	Placebo	Participants will receive placebo from Day 1.
OG001	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.
OG002	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.
OG003	30 mg JZP385

Secondary

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

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.

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

Posted

Mean

Standard Deviation

score on a scale

Change from baseline to week 12

ID	Title	Description
OG000	Placebo	Participants will receive placebo from Day 1.
OG001	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.
OG002	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.

Secondary

Change From Baseline to Week 12 on the Essential Tremor Embarrassment Assessment (ETEA) Score A as Summarized by Each Dose of JZP385 and Placebo

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

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

Posted

Mean

Standard Deviation

score on a scale

Change from baseline to week 12

ID	Title	Description
OG000	Placebo	Participants will receive placebo from Day 1.
OG001	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.
OG002	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.

Secondary

Change From Baseline to Week 12 on the Essential Tremor Embarrassment Assessment (ETEA) Score B as Summarized by Each Dose of JZP385 and Placebo

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

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

Posted

Mean

Standard Deviation

score on a scale

Change from baseline to week 12

ID	Title	Description
OG000	Placebo	Participants will receive placebo from Day 1.
OG001	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.
OG002	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.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary artery disease	Cardiac disorders	MedDRA27	Systematic Assessment	EG0000 events0 affected104 at risk EG0010 events0 affected104 at risk EG0021 events1 affected103 at risk EG0030 events0 affected105 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA27	Systematic Assessment	EG0000 events0 affected104 at risk EG0010 events0 affected104 at risk EG0020 events0 affected103 at risk EG003
Chest pain	General disorders	MedDRA27	Systematic Assessment	EG0000 events0 affected104 at risk EG0011 events1 affected104 at risk EG0020 events0 affected103 at risk EG003
Abscess limb	Infections and infestations	MedDRA27	Systematic Assessment	EG0000 events0 affected104 at risk EG0010 events0 affected104 at risk EG0021 events1 affected103 at risk EG003
Pneumonia	Infections and infestations	MedDRA27	Systematic Assessment	EG0000 events0 affected104 at risk EG0010 events0 affected104 at risk EG0021 events1 affected103 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA27	Systematic Assessment	EG0001 events1 affected104 at risk EG0010 events0 affected104 at risk EG0020 events0 affected103 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA27	Systematic Assessment	EG0001 events1 affected104 at risk EG0010 events0 affected104 at risk EG0020 events0 affected103 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA27	Systematic Assessment	EG0000 events0 affected104 at risk EG0010 events0 affected104 at risk EG0021 events1 affected103 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA27	Systematic Assessment	EG0000 events0 affected104 at risk EG0010 events0 affected104 at risk EG0021 events1 affected103 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA27	Systematic Assessment	EG0000 events0 affected104 at risk EG0010 events0 affected104 at risk EG0020 events0 affected103 at risk EG003
Intercostal neuralgia	Nervous system disorders	MedDRA27	Systematic Assessment	EG0000 events0 affected104 at risk EG0010 events0 affected104 at risk EG0020 events0 affected103 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA27	Systematic Assessment	EG0000 events0 affected104 at risk EG0011 events1 affected104 at risk EG0020 events0 affected103 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA27	Systematic Assessment	EG0000 events0 affected104 at risk EG0011 events1 affected104 at risk EG0020 events0 affected103 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA27	Systematic Assessment	EG0000 events0 affected104 at risk EG0010 events0 affected104 at risk EG0020 events0 affected103 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA27	Systematic Assessment	EG0002 events1 affected104 at risk EG0010 events0 affected104 at risk EG0020 events0 affected103 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA27	Systematic Assessment	EG0000 events0 affected104 at risk EG0010 events0 affected104 at risk EG0020 events0 affected103 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA27	Systematic Assessment	EG0001 events1 affected104 at risk EG0016 events6 affected104 at risk EG0025 events4 affected103 at risk EG0035 events5 affected105 at risk
Dry mouth	Gastrointestinal disorders	MedDRA27	Systematic Assessment	EG0001 events1 affected104 at risk EG0016 events6 affected104 at risk EG0021 events1 affected103 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA27	Systematic Assessment	EG0002 events1 affected104 at risk EG0016 events6 affected104 at risk EG0023 events3 affected103 at risk EG003
Fatigue	General disorders	MedDRA27	Systematic Assessment	EG0001 events1 affected104 at risk EG0014 events4 affected104 at risk EG0023 events3 affected103 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA27	Systematic Assessment	EG0005 events5 affected104 at risk EG0016 events6 affected104 at risk EG0020 events0 affected103 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA27	Systematic Assessment	EG0000 events0 affected104 at risk EG0012 events2 affected104 at risk EG0026 events6 affected103 at risk EG003
Dizziness	Nervous system disorders	MedDRA27	Systematic Assessment	EG0009 events7 affected104 at risk EG00112 events11 affected104 at risk EG00214 events11 affected103 at risk EG003
Headache	Nervous system disorders	MedDRA27	Systematic Assessment	EG0005 events5 affected104 at risk EG0018 events8 affected104 at risk EG0023 events3 affected103 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA27	Systematic Assessment	EG0000 events0 affected104 at risk EG0011 events1 affected104 at risk EG0026 events6 affected103 at risk EG003
Somnolence	Nervous system disorders	MedDRA27	Systematic Assessment	EG0004 events4 affected104 at risk EG0012 events2 affected104 at risk EG0026 events5 affected103 at risk EG003
Tremor	Nervous system disorders	MedDRA27	Systematic Assessment	EG0002 events2 affected104 at risk EG0013 events1 affected104 at risk EG0023 events3 affected103 at risk EG003
Anxiety	Psychiatric disorders	MedDRA27	Systematic Assessment	EG0000 events0 affected104 at risk EG0016 events6 affected104 at risk EG0022 events2 affected103 at risk EG003
Insomnia	Psychiatric disorders	MedDRA27	Systematic Assessment	EG0002 events2 affected104 at risk EG0015 events5 affected104 at risk EG0023 events3 affected103 at risk EG003

ID	Term
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020820	Dyskinesias
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Placebo	Participants will receive placebo from Day 1.
BG001	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.
BG002	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.
BG003	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.
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants will receive placebo from Day 1.	1	104	3	104	20	104
EG001	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.	0	104	3	104	35	104
EG002	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.	0	103	4	103	35	103
EG003	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.	0	105	4	105	46	105

ID	Term
D020329	Essential Tremor
D009069	Movement Disorders
D014202	Tremor