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Essential TremorPhase 2NCT05122650

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

A Phase 2 study testing JZP385 in people with Essential Tremor, run by Jazz Pharmaceuticals at 73 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Essential Tremor
What is being tested?
JZP385
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
420 participants
Where
73 sitesin 4 countries
Study dates
6 Dec 2021to 30 May 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

73 sites in 4 countries.

73 sites in 4 countries

United States41 sites

  • Neurology of Central Florida Research Center

    Altamonte Springs, Florida, 32714

  • Dent Neurological Institute

    Amherst, New York, 14226

  • Neurotrials Research, Inc.

    Atlanta, Georgia, 30328

  • Brain Health Center, Emory University

    Atlanta, Georgia, 30329

  • JEM Research Institute

    Atlantis, Florida, 33462

  • American Clinical Research Institute LLC

    Beavercreek, Ohio, 45432

  • Pillar Clinical Research, LLC

    Bentonville, Arkansas, 72712

  • The University Of Alabama At Birmingham (Uab)

    Birmingham, Alabama, 35233

  • Parkinson's Disease And Movement Disorder Center Of Boca Raton

    Boca Raton, Florida, 33486

  • NeuroScience Research Center

    Canton, Ohio, 44718

  • Northwestern University - Feinberg School of Medicine - Parkinsonÿs Disease and Movement Disorders Center

    Chicago, Illinois, 60611

  • Innovative Research Of West Florida, Inc.

    Clearwater, Florida, 33756

  • Vaught Neurological Services, PLLC

    Crab Orchard, West Virginia, 25827

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • Duke University Health System

    Durham, North Carolina, 27705

  • QUEST Research Institute

    Farmington Hills, Michigan, 48334

  • The Parkinson's and Movement Disorder Institute

    Fountain Valley, California, 92708

  • Infinity Clinical Research, Llc

    Hollywood, Florida, 33024

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817

  • Houston Methodist Hospital - Movement Disorders Clinic

    Houston, Texas, 77030

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 33217

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Booth Gardner Parkinson's Care Center

    Kirkland, Washington, 98034

  • Keck School of Medicine USC - Healthcare Consultation Center 2 (HCCII)

    Los Angeles, California, 90033

  • SC3 Research - Beverly

    Los Angeles, California, 90048

  • University of Louisville, Movement Disorder Clinic

    Louisville, Kentucky, 40202

  • Homestead Associates in Research, Inc.

    Miami, Florida, 33032

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • University Nebraska Medical Center

    Omaha, Nebraska, 68198

  • SC3 Research Pasadena

    Pasadena, California, 91105

  • South Shore Neurology Associates, Inc.

    Patchogue, New York, 11772

  • St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center

    Phoenix, Arizona, 85013

  • Arizona Neuroscience Research, LLC

    Phoenix, Arizona, 85032

  • University of Rochester Medical Center

    Rochester, New York, 14618

  • Woodland Research Northwest, LLC

    Rogers, Arkansas, 72758

  • Imaging Endpoints II, LLC

    Scottsdale, Arizona, 85258

  • Movement Disorders Center of Arizona

    Scottsdale, Arizona, 85258

  • Richmond Behavioral Associates

    Staten Island, New York, 10314

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • USF Carol and Frank Morsani Center for Advanced Healthcare

    Tampa, Florida, 33612

  • University of South Florida Parkinson's Disease and Movement Disorders Center

    Tampa, Florida, 33613

Other trials in United States

Poland14 sites

  • Medicover Integrated Clinical Services (MICS) Centrum Medyczne Bydgoszcz

    Bydgoszcz, 85-065

  • Neuro-Care Sp. Z.o.o. sp. Komandytowa

    Katowice, Silesian Voivodeship, 40-749

  • NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis

    Katowice, 40-123

  • Centrum Medyczne Plejady

    Krakow, 30-363

  • Specjalistyczne Gabinety Sp. z o.o

    Krakow, 30-539

  • Landa Specjalistyczne Gabinety Lekarskie

    Krakow, 31-156

  • Krakowska Akademia Neurologii Sp. z o.o

    Krakow, 31-505

  • Linden Centrum Medyczne

    Krakow, 31-721

  • Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) Neuromed M. i M. Nastaj Spolka Partnerska( Sp.P.)

    Lublin, 20-064

  • Centrum Zdrowia I Urody Maxxmed

    Lublin, 20-080

  • Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki Hertmanowskiej

    Plewiska, 62-064

  • Rivermed Sp z o.o

    Poznan, 61-441

  • ETG Neuroscience

    Warsaw, 02-777

  • MD Clinic Praga Spolka z o. o.

    Warsaw, 03-505

Other trials in Poland

Germany9 sites

  • Zentrum for klinische Forschung Dr. med. Irma Schoell

    Bad Homburg, 61350

  • Pharmakologisches Studienzentrum Chemnitz

    Chemnitz, 09111

  • University Hospital Duesseldorf

    Düsseldorf, 40225

  • Klinik Haag i. OB

    Haag, 83527

  • CRC Core Facility Medizinische Hochschule Hannover (MHH)

    Hanover, 30625

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

  • Velocity Clinical Research Germany GmbH

    Wiesbaden, Hesse, 65189

  • DKD HELIOS Klinik Wiesbaden

    Wiesbaden, 65191

  • Klinikum der Julius-Maximilians-Universitaet Wuerzburg

    Würzburg, 97080

Other trials in Germany

Spain9 sites

  • Hospital de Cruces

    Barakaldo, 48903

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Policlinica Gipuzkoa

    Donostia / San Sebastian, 20014

  • CAE Oroitu (Centro de Atencion Especializada)

    Getxo, Vizcaya, 48993

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, 28222

  • Hospital Universitario Virgen Macarena-merge

    Seville, Andalusia, 41009

Other trials in Spain

About this study

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

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.

Being tested
JZP385, Placebo
Keywords
JZP385, T-type calcium channels, Movement disorder, Tremor, Moderate to severe essential tremor
Medical subject headings
Essential Tremor, Movement Disorders, Tremor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JZP385Drug

    JZP385 capsules will be administered orally (PO) once daily in the morning on an empty stomach for 12 weeks.

  • PlaceboOther

    Placebo capsules will be administered orally (PO) once daily in the morning on an empty stomach for 12 weeks.

Study groups in NCT05122650
Study groupRoleWhat they receive
10 milligram (mg) JZP385ExperimentalParticipants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.
Receives: Drug: JZP385
20 mg JZP385ExperimentalParticipants 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.
Receives: Drug: JZP385
30 mg JZP385ExperimentalParticipants 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.
Receives: Drug: JZP385
PlaceboPlacebo comparatorParticipants will receive placebo from Day 1.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline to week 12

Secondary outcomes (10)

  1. 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).

    Measured: Change from baseline to week 12

  2. 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).

    Measured: Week 12

  3. 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).

    Measured: Change from baseline to week 12

  4. 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.

    Measured: Change from baseline to week 12

  5. 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.

    Measured: Change from baseline to week 12

  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

    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.

    Measured: Change from baseline to week 12

  7. 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.

    Measured: Change from baseline to week 12

  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

    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.

    Measured: Change from baseline to week 12

  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

    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

    Measured: Change from baseline to week 12

  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

    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

    Measured: Change from baseline to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2021
  2. Study start6 Dec 2021
  3. Primary completion30 May 2024
  4. Study completion30 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
420 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05122650
Sponsor's protocol ID
JZP385-201
Other IDs
2020-002463-61
Status last verified
Jul 2025
First submitted
2 Nov 2021
Last updated
24 Jul 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JZP385 in people with Essential Tremor, run by Jazz Pharmaceuticals at 73 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Poland, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 12 on the TETRAS Composite Outcome Score as Summarized by Each Dose of JZP385 and Placebo (time frame: Change from baseline to week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05122650.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.

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