Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44344   clinical trials with a EudraCT protocol, of which   7373   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 2b, 12-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor

    Summary
    EudraCT number
    		 2020-002463-61
    Trial protocol
    		 DE   ES   PL  
    Global end of trial date
    30 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jun 2025
    First version publication date
    15 Jun 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    JZP385-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05122650
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Jazz Pharmaceuticals, Inc.
    Sponsor organisation address
    3170 Porter Drive, Palo Alto, United States, 94304
    Public contact
    Director Clinical Trial Disclosure & Transparency, Jazz Pharmaceuticals, Inc., +1 215-832-3750, ClinicalTrialDisclosure@JazzPharma.com
    Scientific contact
    Director Clinical Trial Disclosure & Transparency, Jazz Pharmaceuticals, Inc., +1 215-832-3750, ClinicalTrialDisclosure@JazzPharma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Jun 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial was to evaluate the efficacy of JZP385 to improve functional and performance-based impairment due to tremor when administered QD for up to 12 weeks at fixed doses of 10, 20, and 30 mg/day.
    Protection of trial subjects
    The protocol, protocol amendments, ICF, investigator brochure, and other relevant documents (eg, advertisements) were submitted to an IRB/IEC by the investigator and reviewed and approved by the IRB/IEC before the study was initiated. This study was conducted in accordance with the protocol and consensus ethical principles derived from international guidelines including the Declaration of Helsinki, Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable ICH GCP Guidelines, and other applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Dec 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 205
    Country: Number of subjects enrolled
    Germany: 28
    Country: Number of subjects enrolled
    Poland: 151
    Country: Number of subjects enrolled
    Spain: 36
    Worldwide total number of subjects
    420
    EEA total number of subjects
    215
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    187
    From 65 to 84 years
    233
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 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 Safety Analysis Set.

    Pre-assignment
    Screening details
    		 The screening Period lasted up to 35 days, with an additional 28 days were permitted for participants who required washout of restricted medications.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants will receive placebo from Day 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were instructed to take this intervention in the morning QD on an empty stomach.

    Arm title
    		 10 milligram (mg) JZP385
    Arm description
    		 Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JZP385
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were instructed to take this intervention in the morning QD on an empty stomach.

    Arm title
    		 20 mg JZP385
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JZP385
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were instructed to take this intervention in the morning QD on an empty stomach.

    Arm title
    		 30 mg JZP385
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JZP385
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were instructed to take this intervention in the morning QD on an empty stomach.

    Number of subjects in period 1
    		Placebo 10 milligram (mg) JZP385 20 mg JZP385 30 mg JZP385
    Started
    104
    105
    104
    107
    Completed
    91
    78
    81
    78
    Not completed
    13
    27
    23
    29
         Consent withdrawn by subject
    3
    7
    4
    8
         Adverse event, non-fatal
    4
    16
    11
    12
         Not specified
    5
    -
    -
    -
         Sponsor request
    -
    1
    1
    2
         Randomized by mistake
    -
    -
    3
    2
         Non-compliance with study intervention
    -
    -
    -
    2
         Lost to follow-up
    1
    1
    3
    -
         Lack of efficacy
    -
    1
    1
    2
         Protocol deviation
    -
    1
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants will receive placebo from Day 1.

    Reporting group title
    10 milligram (mg) JZP385
    Reporting group description
    		 Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.

    Reporting group title
    20 mg JZP385
    Reporting group description
    		 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.

    Reporting group title
    30 mg JZP385
    Reporting group description
    		 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.

    Reporting group values
    		 Placebo 10 milligram (mg) JZP385 20 mg JZP385 30 mg JZP385 Total
    Number of subjects
    		 104 105 104 107
    Age Categorical
    Units: Subjects
    Gender categorical
    Units: Subjects
        Female
    		 41 37 33 49 160
        Male
    		 63 68 71 58 260
    Age categorical
    Units: Subjects
        <= 18 years
    		 0 0 0 0 0
        Between 18 and 65
    		 43 51 45 48 187
        >= 65 years
    		 61 54 59 59 233
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 0 0 1
        Asian
    		 0 1 0 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 0 0 4 4 8
        White
    		 98 96 93 92 379
        More than one race
    		 0 1 1 2 4
        Unknown or Not Reported
    		 5 7 6 9 27
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 11 10 9 11 41
        Not Hispanic or Latino
    		 93 95 95 96 379
        Unknown or Not Reported
    		 0 0 0 0 0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants will receive placebo from Day 1.

    Reporting group title
    10 milligram (mg) JZP385
    Reporting group description
    		 Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.

    Reporting group title
    20 mg JZP385
    Reporting group description
    		 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.

    Reporting group title
    30 mg JZP385
    Reporting group description
    		 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.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants will receive placebo from Day 1.

    Subject analysis set title
    10 milligram (mg) JZP385
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.

    Subject analysis set title
    20 mg JZP385
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    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.

    Subject analysis set title
    30 mg JZP385
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    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.

    Primary: Change from Baseline to Week 12 on the TETRAS composite outcome score as summarized by each dose of JZP385 and placebo

    		 Close Top of page
    End point title
    		 Change from Baseline to Week 12 on the TETRAS composite outcome score as summarized by each dose of JZP385 and placebo [1]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Change from baseline to week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were used to assess this outcome measure.
    End point values
    		 Placebo 10 milligram (mg) JZP385 20 mg JZP385 30 mg JZP385
    Number of subjects analysed
    94
    79
    82
    78
    Units: score on a scale
        arithmetic mean (standard deviation)
    -6.3 ( 6.22 )
    -5.8 ( 6.85 )
    -6.7 ( 6.88 )
    -7.5 ( 7.31 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Improved (≥ 1-Point Improvement) from Baseline to Week 12 on the Clinical Global Impression- Severity scale (CGI-S)

    		 Close Top of page
    End point title
    		 Percentage of Participants who Improved (≥ 1-Point Improvement) from Baseline to Week 12 on the Clinical Global Impression- Severity scale (CGI-S)
    End point description
    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).
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 12
    End point values
    		 Placebo 10 milligram (mg) JZP385 20 mg JZP385 30 mg JZP385
    Number of subjects analysed
    104
    105
    104
    107
    Units: Percentage of participants
        number (not applicable)
    50.0
    49.8
    55.7
    62.8
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Proportion of Participants Reported as Much Improved on the Patient Global Impression of Change (PGI-C) at Week 12
    End point description
    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).
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 12
    End point values
    		 Placebo 10 milligram (mg) JZP385 20 mg JZP385 30 mg JZP385
    Number of subjects analysed
    94
    79
    82
    79
    Units: participants
        number (not applicable)
    16
    11
    20
    32
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Proportion of Participants Reported as Much Improved on the Clinical Global Impression of Change (CGI-C) at Week 12
    End point description
    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).
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo 10 milligram (mg) JZP385 20 mg JZP385 30 mg JZP385
    Number of subjects analysed
    94
    79
    82
    79
    Units: participants
    22
    18
    19
    30
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 12 on the TETRAS-ADL subscale as Summarized by Each Dose of JZP385 and Placebo

    		 Close Top of page
    End point title
    		 Change from Baseline to Week 12 on the TETRAS-ADL subscale as Summarized by Each Dose of JZP385 and Placebo
    End point description
    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 higher scores representing more severe ET.
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 12
    End point values
    		 Placebo 10 milligram (mg) JZP385 20 mg JZP385 30 mg JZP385
    Number of subjects analysed
    94
    79
    82
    79
    Units: score on a scale
        arithmetic mean (standard deviation)
    -6.4 ( 6.40 )
    -6.3 ( 7.55 )
    -7.1 ( 7.88 )
    -8.7 ( 8.49 )
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Change from Baseline to Week 12 on the TETRAS-PS Subscale as Summarized by Each Dose of JZP385 and Placebo
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 12
    End point values
    		 Placebo 10 milligram (mg) JZP385 20 mg JZP385 30 mg JZP385
    Number of subjects analysed
    94
    79
    82
    78
    Units: score on a scale
        arithmetic mean (standard deviation)
    -5.4 ( 5.73 )
    -5.3 ( 6.57 )
    -5.1 ( 6.15 )
    -5.5 ( 6.27 )
    No statistical analyses for this end point

    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

    		 Close Top of page
    End point title
    		 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
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 12
    End point values
    		 Placebo 10 milligram (mg) JZP385 20 mg JZP385 30 mg JZP385
    Number of subjects analysed
    94
    79
    82
    78
    Units: score on a scale
        arithmetic mean (standard deviation)
    -2.3 ( 2.68 )
    -2.4 ( 2.78 )
    -2.0 ( 2.61 )
    -2.4 ( 2.81 )
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Change from Baseline to Week 12 on the TETRAS Total Score, as Summarized by Each Dose of JZP385 and Placebo.
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 12
    End point values
    		 Placebo 10 milligram (mg) JZP385 20 mg JZP385 30 mg JZP385
    Number of subjects analysed
    94
    79
    82
    78
    Units: score on a scale
        arithmetic mean (standard deviation)
    -11.8 ( 10.18 )
    -11.6 ( 11.54 )
    -12.3 ( 11.95 )
    -14.4 ( 12.20 )
    No statistical analyses for this end point

    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

    		 Close Top of page
    End point title
    		 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
    End point description
    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), with higher scores indicating greater dissatisfaction or disability due to ET.
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 12
    End point values
    		 Placebo 10 milligram (mg) JZP385 20 mg JZP385 30 mg JZP385
    Number of subjects analysed
    99
    100
    95
    98
    Units: score on a scale
    arithmetic mean (standard deviation)
        Communication Subscale Total Score
    -5.5 ( 15.35 )
    -3.3 ( 15.62 )
    -3.5 ( 14.67 )
    -7.8 ( 16.18 )
        Work and Finance Subscale Total Score
    -5.8 ( 16.44 )
    1.0 ( 17.26 )
    -6.1 ( 15.61 )
    -6.7 ( 15.11 )
        Hobbies and Leisure Subscale Total Score
    -1.1 ( 29.35 )
    -8.9 ( 31.66 )
    -3.5 ( 36.50 )
    -10.2 ( 33.81 )
        Physical Subscale Total Score
    -11.0 ( 17.65 )
    -5.1 ( 17.60 )
    -10.1 ( 16.85 )
    -13.4 ( 20.24 )
        Psychosocial Subscale Total Score
    -6.8 ( 14.93 )
    -2.9 ( 16.57 )
    -6.1 ( 15.79 )
    -6.2 ( 15.40 )
    No statistical analyses for this end point

    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

    		 Close Top of page
    End point title
    		 Change from Baseline to Week 12 on the Essential Tremor Embarrassment Assessment (ETEA) Score A as Summarized by Each Dose of JZP385 and Placebo
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 12
    End point values
    		 Placebo 10 milligram (mg) JZP385 20 mg JZP385 30 mg JZP385
    Number of subjects analysed
    98
    99
    95
    97
    Units: score on a scale
        arithmetic mean (standard deviation)
    -0.6 ( 2.84 )
    -0.5 ( 3.06 )
    -0.6 ( 3.60 )
    -1.2 ( 3.51 )
    No statistical analyses for this end point

    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

    		 Close Top of page
    End point title
    		 Change From Baseline to Week 12 on the Essential Tremor Embarrassment Assessment (ETEA) Score B as Summarized by Each Dose of JZP385 and Placebo
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 12
    End point values
    		 Placebo 10 milligram (mg) JZP385 20 mg JZP385 30 mg JZP385
    Number of subjects analysed
    98
    99
    95
    97
    Units: score on a scale
        arithmetic mean (standard deviation)
    -4.2 ( 12.87 )
    -3.5 ( 14.15 )
    -4.6 ( 14.42 )
    -5.6 ( 14.28 )
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from baseline up to 14 weeks.
    Adverse event reporting additional description
    AEs were only collected in the 416 participants who received at least 1 dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants will receive placebo from Day 1.

    Reporting group title
    20 mg JZP385
    Reporting group description
    		 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.

    Reporting group title
    30 mg JZP385
    Reporting group description
    		 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.

    Reporting group title
    10 milligram (mg) JZP385
    Reporting group description
    		 Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.

    Serious adverse events
    		 Placebo 20 mg JZP385 30 mg JZP385 10 milligram (mg) JZP385
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 104 (2.88%)
    4 / 103 (3.88%)
    4 / 105 (3.81%)
    3 / 104 (2.88%)
         number of deaths (all causes)
    1
    0
    0
    0
         number of deaths resulting from adverse events
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 103 (0.00%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 103 (0.97%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 103 (0.97%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    1 / 105 (0.95%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    1 / 105 (0.95%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 103 (0.97%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Intercostal neuralgia
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    1 / 105 (0.95%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    0 / 105 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    0 / 105 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    1 / 105 (0.95%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    0 / 105 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 103 (0.00%)
    1 / 105 (0.95%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 103 (0.00%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 103 (0.97%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 103 (0.00%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 103 (0.97%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo 20 mg JZP385 30 mg JZP385 10 milligram (mg) JZP385
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 104 (19.23%)
    35 / 103 (33.98%)
    46 / 105 (43.81%)
    35 / 104 (33.65%)
    Nervous system disorders
    Disturbance in attention
         subjects affected / exposed
    0 / 104 (0.00%)
    6 / 103 (5.83%)
    4 / 105 (3.81%)
    2 / 104 (1.92%)
         occurrences all number
    0
    6
    4
    2
    Dizziness
         subjects affected / exposed
    7 / 104 (6.73%)
    11 / 103 (10.68%)
    12 / 105 (11.43%)
    11 / 104 (10.58%)
         occurrences all number
    9
    14
    15
    12
    Tremor
         subjects affected / exposed
    2 / 104 (1.92%)
    3 / 103 (2.91%)
    7 / 105 (6.67%)
    1 / 104 (0.96%)
         occurrences all number
    2
    3
    7
    3
    Headache
         subjects affected / exposed
    5 / 104 (4.81%)
    3 / 103 (2.91%)
    5 / 105 (4.76%)
    8 / 104 (7.69%)
         occurrences all number
    5
    3
    5
    8
    Paraesthesia
         subjects affected / exposed
    0 / 104 (0.00%)
    6 / 103 (5.83%)
    9 / 105 (8.57%)
    1 / 104 (0.96%)
         occurrences all number
    0
    6
    10
    1
    Somnolence
         subjects affected / exposed
    4 / 104 (3.85%)
    5 / 103 (4.85%)
    7 / 105 (6.67%)
    2 / 104 (1.92%)
         occurrences all number
    4
    6
    8
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 104 (0.96%)
    3 / 103 (2.91%)
    7 / 105 (6.67%)
    4 / 104 (3.85%)
         occurrences all number
    1
    3
    7
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 104 (0.96%)
    4 / 103 (3.88%)
    5 / 105 (4.76%)
    6 / 104 (5.77%)
         occurrences all number
    1
    5
    5
    6
    Dry mouth
         subjects affected / exposed
    1 / 104 (0.96%)
    1 / 103 (0.97%)
    5 / 105 (4.76%)
    6 / 104 (5.77%)
         occurrences all number
    1
    1
    5
    6
    Nausea
         subjects affected / exposed
    1 / 104 (0.96%)
    3 / 103 (2.91%)
    4 / 105 (3.81%)
    6 / 104 (5.77%)
         occurrences all number
    2
    3
    4
    6
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 104 (0.00%)
    2 / 103 (1.94%)
    3 / 105 (2.86%)
    6 / 104 (5.77%)
         occurrences all number
    0
    2
    3
    6
    Insomnia
         subjects affected / exposed
    2 / 104 (1.92%)
    3 / 103 (2.91%)
    7 / 105 (6.67%)
    5 / 104 (4.81%)
         occurrences all number
    2
    3
    7
    5
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 104 (4.81%)
    0 / 103 (0.00%)
    4 / 105 (3.81%)
    6 / 104 (5.77%)
         occurrences all number
    5
    0
    5
    6

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 May 2021
    This amendment was implemented to align with feedback received from the United States Food and Drug Administration (FDA) regarding study endpoints, to correct an error in the hepatic and renal values necessary for participant exclusion, and to add general clarifications throughout the protocol.
    15 Nov 2021
    This amendment was implemented to revise text regarding participant rollover into a separate long-term study, remove CYP2C9 inducers from the exclusion criteria, and to make other minor edits.
    07 Oct 2022
    The overall rationale for this amendment was to broaden the eligibility criteria and reduce study burden.
    10 Feb 2023
    The overall rationale for this amendment was to facilitate participant enrollment by allowing participants to enter the study without having to discontinue concomitant anti-tremor medications, unless these medications (eg, primidone) are prohibited in accordance with other exclusion criteria.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue Jun 17 20:41:24 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA