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

NCT05122650 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: JZP385-2012020-002463-61
• Study Type: interventional
• Target: 420
• Locations: 4 countries
• Sites: 73

Brief 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.

Conditions

Essential Tremor

Keywords

JZP385; T-type calcium channels; Movement disorder; Tremor; Moderate to severe essential tremor

Outcome Measures

Primary Outcomes (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.

  Change from baseline to week 12

Secondary Outcomes (10)

• 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

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

  Week 12

• 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

• 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

• 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

Study Arms (4)

10 milligram (mg) JZP385

EXPERIMENTAL

Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.

Drug: JZP385

20 mg JZP385

EXPERIMENTAL

Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, and 20 mg/day starting on Day 15.

Drug: JZP385

30 mg JZP385

EXPERIMENTAL

Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, 20 mg/day from Day 15 through Day 21, and 30 mg/day starting on Day 22.

Drug: JZP385

Placebo

PLACEBO COMPARATOR

Participants will receive placebo from Day 1.

Other: Placebo

Interventions

JZP385 DRUG

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

10 milligram (mg) JZP385; 20 mg JZP385; 30 mg JZP385

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent.
• Participants who are diagnosed with ET (including ET plus) according to the MDS Consensus Statement on the Classification of Tremors from the Task Force on Tremor of the International Parkinson's and Movement Disorder Society.
• Participants have moderate to severe disability associated with tremor as determined by a score of ≥ 22 on the TETRAS-ADL subscale and a CGI-S rating of at least moderate for participants' ability to function.
• Sex and Contraceptive/Barrier Requirements
• During the study intervention and for at least 30 days after the last dose of study intervention male participants must refrain from donating sperm. Non-abstinent males must agree to use a male condom in combination with female partner use of a highly effective contraceptive method with a failure rate of \< 1% per year. All male participants must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person.
• Female participants must not be pregnant or breastfeeding, are either women of non-childbearing potential (WONCBP), or are women of childbearing potential (WOCBP) using a highly effective contraceptive method with a failure rate of \< 1% during the study intervention period and for at least 30 days after the last dose of study intervention. Male partners of WOCBP are required to use barrier protection, eg, condoms, from the first dose of study intervention until 30 days after the last dose of study intervention.
• A WOCBP must have a negative highly sensitive serum pregnancy test at Screening Visit 1 and negative urine pregnancy tests (unless serum is required by local regulations) at the Screening Visit 2 (if applicable) and at the Baseline Visit
• \- If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
• Prior/Concomitant Antitremor Medications

You may not qualify if:

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

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (73)

The University Of Alabama At Birmingham (Uab)

Birmingham, Alabama, 35233, United States

Location

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

Phoenix, Arizona, 85013, United States

Location

Arizona Neuroscience Research, LLC

Phoenix, Arizona, 85032, United States

Location

Imaging Endpoints II, LLC

Scottsdale, Arizona, 85258, United States

Location

Movement Disorders Center of Arizona

Scottsdale, Arizona, 85258, United States

Location

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

Pillar Clinical Research, LLC

Bentonville, Arkansas, 72712, United States

Location

Woodland Research Northwest, LLC

Rogers, Arkansas, 72758, United States

Location

The Parkinson's and Movement Disorder Institute

Fountain Valley, California, 92708, United States

Location

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

Los Angeles, California, 90033, United States

Location

SC3 Research - Beverly

Los Angeles, California, 90048, United States

Location

SC3 Research Pasadena

Pasadena, California, 91105, United States

Location

Neurology of Central Florida Research Center

Altamonte Springs, Florida, 32714, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

Parkinson's Disease And Movement Disorder Center Of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Innovative Research Of West Florida, Inc.

Clearwater, Florida, 33756, United States

Location

Infinity Clinical Research, Llc

Hollywood, Florida, 33024, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 33217, United States

Location

Homestead Associates in Research, Inc.

Miami, Florida, 33032, United States

Location

USF Carol and Frank Morsani Center for Advanced Healthcare

Tampa, Florida, 33612, United States

Location

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

Tampa, Florida, 33613, United States

Location

Neurotrials Research, Inc.

Atlanta, Georgia, 30328, United States

Location

Brain Health Center, Emory University

Atlanta, Georgia, 30329, United States

Location

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817, United States

Location

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

Chicago, Illinois, 60611, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Louisville, Movement Disorder Clinic

Louisville, Kentucky, 40202, United States

Location

QUEST Research Institute

Farmington Hills, Michigan, 48334, United States

Location

University Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Dent Neurological Institute

Amherst, New York, 14226, United States

Location

South Shore Neurology Associates, Inc.

Patchogue, New York, 11772, United States

Location

University of Rochester Medical Center

Rochester, New York, 14618, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10314, United States

Location

Duke University Health System

Durham, North Carolina, 27705, United States

Location

American Clinical Research Institute LLC

Beavercreek, Ohio, 45432, United States

Location

NeuroScience Research Center

Canton, Ohio, 44718, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Houston Methodist Hospital - Movement Disorders Clinic

Houston, Texas, 77030, United States

Location

Booth Gardner Parkinson's Care Center

Kirkland, Washington, 98034, United States

Location

Vaught Neurological Services, PLLC

Crab Orchard, West Virginia, 25827, United States

Location

Universitaetsklinikum Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Velocity Clinical Research Germany GmbH

Wiesbaden, Hesse, 65189, Germany

Location

Zentrum for klinische Forschung Dr. med. Irma Schoell

Bad Homburg, 61350, Germany

Location

Pharmakologisches Studienzentrum Chemnitz

Chemnitz, 09111, Germany

Location

University Hospital Duesseldorf

Düsseldorf, 40225, Germany

Location

Klinik Haag i. OB

Haag, 83527, Germany

Location

CRC Core Facility Medizinische Hochschule Hannover (MHH)

Hanover, 30625, Germany

Location

DKD HELIOS Klinik Wiesbaden

Wiesbaden, 65191, Germany

Location

Klinikum der Julius-Maximilians-Universitaet Wuerzburg

Würzburg, 97080, Germany

Location

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

Katowice, Silesian Voivodeship, 40-749, Poland

Location

Medicover Integrated Clinical Services (MICS) Centrum Medyczne Bydgoszcz

Bydgoszcz, 85-065, Poland

Location

NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis

Katowice, 40-123, Poland

Location

Centrum Medyczne Plejady

Krakow, 30-363, Poland

Location

Specjalistyczne Gabinety Sp. z o.o

Krakow, 30-539, Poland

Location

Landa Specjalistyczne Gabinety Lekarskie

Krakow, 31-156, Poland

Location

Krakowska Akademia Neurologii Sp. z o.o

Krakow, 31-505, Poland

Location

Linden Centrum Medyczne

Krakow, 31-721, Poland

Location

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

Lublin, 20-064, Poland

Location

Centrum Zdrowia I Urody Maxxmed

Lublin, 20-080, Poland

Location

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

Plewiska, 62-064, Poland

Location

Rivermed Sp z o.o

Poznan, 61-441, Poland

Location

ETG Neuroscience

Warsaw, 02-777, Poland

Location

MD Clinic Praga Spolka z o. o.

Warsaw, 03-505, Poland

Location

Hospital Universitario Virgen Macarena-merge

Seville, Andalusia, 41009, Spain

Location

CAE Oroitu (Centro de Atencion Especializada)

Getxo, Vizcaya, 48993, Spain

Location

Hospital de Cruces

Barakaldo, 48903, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Policlinica Gipuzkoa

Donostia / San Sebastian, 20014, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, 28222, Spain

Location

MeSH Terms

Conditions

Essential Tremor; Movement Disorders; Tremor

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trial Disclosure & Transparency
• Organization: Jazz Pharmaceuticals

ClinicalTrialDisclosure@JazzPharma.com

215-832-3750

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 17, 2021
• Study Start: December 6, 2021
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: July 24, 2025
• Results First Posted: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

ES (9); DE (9); US (41); PL (14)