Trial · NCT05122650
A Study To Assess the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor (ET)
NCT05122650, Phase 2, Completed, Jazz Pharmaceuticals; results first posted 2025-07-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study To Assess the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor (ET). Trials, record NCT05122650. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05122650
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Assess the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor (ET)
- NCT number
- NCT05122650
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 420 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Essential Tremor
- Interventions
- JZP385, Placebo
- First posted
- 2021-11-17
- Last updated
- 2025-07-24
- Other registries' IDs
- eudract:2020-002463-61
- Results first posted
- 2025-07-24
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 12 on the TETRAS Composite Outcome Score as Summarized by Each Dose of JZP385 and Placebo | Change from baseline to week 12 | 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. |
| Secondary | Percentage of Participants Who Improved (≥ 1-Point Improvement) From Baseline to Week 12 on the Clinical Global Impression- Severity Scale (CGI-S) | Change from baseline to week 12 | 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). |
| Secondary | Proportion of Participants Reported as Much Improved on the Clinical Global Impression of Change (CGI-C) at Week 12 | 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). |
| Secondary | Proportion of Participants Reported as Much Improved on the Patient Global Impression of Change (PGI-C) at Week 12 | Change from baseline to 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). |
| Secondary | Change From Baseline to Week 12 on the TETRAS-ADL Subscale as Summarized by Each Dose of JZP385 and Placebo | Change from baseline to week 12 | 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. |
| Secondary | Change From Baseline to Week 12 on the TETRAS-PS Subscale as Summarized by Each Dose of JZP385 and Placebo | Change from baseline to week 12 | 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. |
| 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 | Change from baseline to week 12 | 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. |
| Secondary | Change From Baseline to Week 12 on the TETRAS Total Score, as Summarized by Each Dose of JZP385 and Placebo. | Change from baseline to week 12 | 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. |
| 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 | Change from baseline to week 12 | 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. |
| 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 | Change from baseline to week 12 | 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 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 12 on the TETRAS Composite Outcome Score as Summarized by Each Dose of JZP385 and Placebo | Change from baseline to week 12 | 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. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants Who Improved (≥ 1-Point Improvement) From Baseline to Week 12 on the Clinical Global Impression- Severity Scale (CGI-S) | Change from baseline to week 12 | Inferential analysis results were based on multiple imputations (impute missing values) on all study population | Percentage of participants | NUMBER |
| SECONDARY | Proportion of Participants Reported as Much Improved on the Clinical Global Impression of Change (CGI-C) at Week 12 | Week 12 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants Reported as Much Improved on the Patient Global Impression of Change (PGI-C) at Week 12 | Change from baseline to week 12 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 12 on the TETRAS-ADL Subscale as Summarized by Each Dose of JZP385 and Placebo | Change from baseline to week 12 | 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. | score on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 on the TETRAS-PS Subscale as Summarized by Each Dose of JZP385 and Placebo | Change from baseline to week 12 | 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. | score on a scale | MEAN |
| 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 | Change from baseline to week 12 | 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. | score on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 on the TETRAS Total Score, as Summarized by Each Dose of JZP385 and Placebo. | Change from baseline to week 12 | 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. | score on a scale | MEAN |
| 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 | Change from baseline to week 12 | The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 QUEST assessment. | score on a scale | MEAN |
| 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 | Change from baseline to week 12 | The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 ETEA assessment. | score on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 12 on the TETRAS Composite Outcome Score as Summarized by Each Dose of JZP385 and Placebo | Placebo | -6.3 | Standard Deviation 6.22 | score on a scale | |
| Change From Baseline to Week 12 on the TETRAS Composite Outcome Score as Summarized by Each Dose of JZP385 and Placebo | 10 Milligram (mg) JZP385 | -5.8 | Standard Deviation 6.85 | score on a scale | |
| Change From Baseline to Week 12 on the TETRAS Composite Outcome Score as Summarized by Each Dose of JZP385 and Placebo | 20 mg JZP385 | -6.7 | Standard Deviation 6.88 | score on a scale | |
| Change From Baseline to Week 12 on the TETRAS Composite Outcome Score as Summarized by Each Dose of JZP385 and Placebo | 30 mg JZP385 | -7.5 | Standard Deviation 7.31 | score on a scale | |
| Percentage of Participants Who Improved (≥ 1-Point Improvement) From Baseline to Week 12 on the Clinical Global Impression- Severity Scale (CGI-S) | Placebo | 50.0 | Percentage of participants | ||
| Percentage of Participants Who Improved (≥ 1-Point Improvement) From Baseline to Week 12 on the Clinical Global Impression- Severity Scale (CGI-S) | 10 Milligram (mg) JZP385 | 49.8 | Percentage of participants | ||
| Percentage of Participants Who Improved (≥ 1-Point Improvement) From Baseline to Week 12 on the Clinical Global Impression- Severity Scale (CGI-S) | 20 mg JZP385 | 55.7 | Percentage of participants | ||
| Percentage of Participants Who Improved (≥ 1-Point Improvement) From Baseline to Week 12 on the Clinical Global Impression- Severity Scale (CGI-S) | 30 mg JZP385 | 62.8 | Percentage of participants | ||
| Proportion of Participants Reported as Much Improved on the Clinical Global Impression of Change (CGI-C) at Week 12 | Placebo | 22 | Participants | ||
| Proportion of Participants Reported as Much Improved on the Clinical Global Impression of Change (CGI-C) at Week 12 | 10 Milligram (mg) JZP385 | 18 | Participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 104 | |
| Overall Study | STARTED | 10 Milligram (mg) JZP385 | 105 | |
| Overall Study | STARTED | 20 mg JZP385 | 104 | |
| Overall Study | STARTED | 30 mg JZP385 | 107 | |
| Overall Study | COMPLETED | Placebo | 91 | |
| Overall Study | COMPLETED | 10 Milligram (mg) JZP385 | 78 | |
| Overall Study | COMPLETED | 20 mg JZP385 | 81 | |
| Overall Study | COMPLETED | 30 mg JZP385 | 78 | |
| Overall Study | NOT COMPLETED | Placebo | 13 | |
| Overall Study | NOT COMPLETED | 10 Milligram (mg) JZP385 | 27 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events116
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 104 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | 10 Milligram (mg) JZP385 | 6 | 104 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | 20 mg JZP385 | 4 | 103 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | 30 mg JZP385 | 5 | 105 | 5 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 1 | 104 | 1 |
| other | Dry mouth | Gastrointestinal disorders | 10 Milligram (mg) JZP385 | 6 | 104 | 6 |
| other | Dry mouth | Gastrointestinal disorders | 20 mg JZP385 | 1 | 103 | 1 |
| other | Dry mouth | Gastrointestinal disorders | 30 mg JZP385 | 5 | 105 | 5 |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 104 | 2 |
| other | Nausea | Gastrointestinal disorders | 10 Milligram (mg) JZP385 | 6 | 104 | 6 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 1 | 104 |
| Total, all-cause mortality | 10 Milligram (mg) JZP385 | 0 | 104 |
| Total, all-cause mortality | 20 mg JZP385 | 0 | 103 |
| Total, all-cause mortality | 30 mg JZP385 | 0 | 105 |
| Total, other adverse events | Placebo | 20 | 104 |
| Total, other adverse events | 10 Milligram (mg) JZP385 | 35 | 104 |
| Total, other adverse events | 20 mg JZP385 | 35 | 103 |
| Total, other adverse events | 30 mg JZP385 | 46 | 105 |
| Total, serious adverse events | Placebo | 3 | 104 |
| Total, serious adverse events | 10 Milligram (mg) JZP385 | 3 | 104 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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