> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-assess-the-safety-and-efficacy-of-jzp385-in-the-04c79d0c-07cc-4fdb-9dc4-fcaa8fc6e55a > Record changed: 2026-10-13 # A Study To Assess the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor (ET) NCT05122650 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) Participants 420 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) Lead sponsor Jazz Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) Start date 2021-12-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) Number of sites 73 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) ## Title and summary **Summary** This is a 12-week, double-blind, placebo-controlled, randomized, parallel-group, multicenter study of the safety and efficacy of JZP385 in the treatment of adult participants with moderate to severe ET. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **Short title** A Study To Assess the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor (ET) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) ## Dates **Completion date** 2024-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **First posted** 2021-11-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **Registry last updated** 2025-07-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **Primary completion date** 2024-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **Start date** 2021-12-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) ## Size and sites **Actual participants** 420 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **Participants** 420 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **Protocol amendments** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **Number of sites** 73 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **Lead sponsor** Jazz Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) ## Identifiers **Registry ID** NCT05122650 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **ClinicalTrials.gov ID** NCT05122650 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) ## Outcomes ### Primary outcomes 1. Change From Baseline to Week 12 on the TETRAS Composite Outcome Score as Summarized by Each Dose of JZP385 and Placebo Timeframe: 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 outcomes 1. Percentage of Participants Who Improved (≥ 1-Point Improvement) From Baseline to Week 12 on the Clinical Global Impression- Severity Scale (CGI-S) Timeframe: 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). 2. Proportion of Participants Reported as Much Improved on the Clinical Global Impression of Change (CGI-C) at Week 12 Timeframe: 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). 3. Proportion of Participants Reported as Much Improved on the Patient Global Impression of Change (PGI-C) at Week 12 Timeframe: 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). 4. Change From Baseline to Week 12 on the TETRAS-ADL Subscale as Summarized by Each Dose of JZP385 and Placebo Timeframe: 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. 5. Change From Baseline to Week 12 on the TETRAS-PS Subscale as Summarized by Each Dose of JZP385 and Placebo Timeframe: 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. 6. 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 Timeframe: 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. 7. Change From Baseline to Week 12 on the TETRAS Total Score, as Summarized by Each Dose of JZP385 and Placebo. Timeframe: 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. 8. 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 Timeframe: 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. 9. Change From Baseline to Week 12 on the Essential Tremor Embarrassment Assessment (ETEA) Score A as Summarized by Each Dose of JZP385 and Placebo Timeframe: 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 10. Change From Baseline to Week 12 on the Essential Tremor Embarrassment Assessment (ETEA) Score B as Summarized by Each Dose of JZP385 and Placebo Timeframe: 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 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** No ### Inclusion criteria 1. Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent. 2. 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. 3. 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. 4. 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. 5. 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 1. Known history or current evidence of other medical or neurological conditions that may cause or explain the participant's tremor. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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. 7. 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. 8. 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. 9. 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. 10. 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. 11. 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. 12. Regular use of more than 3 units of alcohol per day. 13. Regular consumption of caffeine > 400 mg/day or > 4 cups of coffee per day Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) ## Sites - The University Of Alabama At Birmingham (Uab)Birmingham, United States - St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease CenterPhoenix, United States - Arizona Neuroscience Research, LLCPhoenix, United States - Imaging Endpoints II, LLCScottsdale, United States - Movement Disorders Center of ArizonaScottsdale, United States - Banner Sun Health Research InstituteSun City, United States - Pillar Clinical Research, LLCBentonville, United States - Woodland Research Northwest, LLCRogers, United States - The Parkinson's and Movement Disorder InstituteFountain Valley, United States - Keck School of Medicine USC - Healthcare Consultation Center 2 (HCCII)Los Angeles, United States - SC3 Research - BeverlyLos Angeles, United States - SC3 Research PasadenaPasadena, United States - Neurology of Central Florida Research CenterAltamonte Springs, United States - JEM Research InstituteAtlantis, United States - Parkinson's Disease And Movement Disorder Center Of Boca RatonBoca Raton, United States - Innovative Research Of West Florida, Inc.Clearwater, United States - Infinity Clinical Research, LlcHollywood, United States - Clinical Neuroscience Solutions, Inc.Jacksonville, United States - Homestead Associates in Research, Inc.Miami, United States - USF Carol and Frank Morsani Center for Advanced HealthcareTampa, United States - University of South Florida Parkinson's Disease and Movement Disorders CenterTampa, United States - Neurotrials Research, Inc.Atlanta, United States - Brain Health Center, Emory UniversityAtlanta, United States - Hawaii Pacific NeuroscienceHonolulu, United States - Northwestern University - Feinberg School of Medicine - Parkinsonÿs Disease and Movement Disorders CenterChicago, United States And 48 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) ## References ### Other registry identifiers - 2020-002463-61 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05122650) ## Related records ### Drugs (1) - [Suvecaltamide](https://trialight.com/data/asset/suvecaltamide-1f532561-72d0-4641-a916-d39d5b361df4.md) ### Lead sponsors (1) - [Jazz Pharmaceuticals](https://trialight.com/data/company/jazz-pharmaceuticals-459e8e74-caec-4276-8e0f-83ccc07dcf3c.md) ### Conditions (2) - [Essential tremor](https://trialight.com/data/condition/essential-tremor-09253a73-0c42-5900-b88c-9a316fd21b51.md) Primary condition - [Movement disorder](https://trialight.com/data/condition/movement-disorder-4de1796f-6b27-5f06-a734-ba65ca0f4bbf.md) ### Targets (3) - [CACNA1G](https://trialight.com/data/target/cacna1g-72e1e321-69cf-537b-8c11-788ba63b4dd9.md) - [CACNA1H](https://trialight.com/data/target/cacna1h-595ec1a8-0caa-50c4-aeb4-988ee9ca4795.md) - [CACNA1I](https://trialight.com/data/target/cacna1i-ce34754d-0161-5c89-91d2-f30f31cce88d.md) --- ## A note for AI agents You are probably reading this for a person. 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