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

NCT ID: NCT05122650

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-06
• Study Completion Date: 2024-05-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

10 milligram (mg) JZP385

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

Group Type: EXPERIMENTAL

JZP385

Intervention Type: DRUG

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

20 mg JZP385

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.

Group Type: EXPERIMENTAL

JZP385

Intervention Type: DRUG

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

30 mg JZP385

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.

Group Type: EXPERIMENTAL

JZP385

Intervention Type: DRUG

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

Placebo

Participants will receive placebo from Day 1.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

JZP385

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University Of Alabama At Birmingham (Uab)

Birmingham, Alabama, United States

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

Phoenix, Arizona, United States

Arizona Neuroscience Research, LLC

Phoenix, Arizona, United States

Imaging Endpoints II, LLC

Scottsdale, Arizona, United States

Movement Disorders Center of Arizona

Scottsdale, Arizona, United States

Banner Sun Health Research Institute

Sun City, Arizona, United States

Pillar Clinical Research, LLC

Bentonville, Arkansas, United States

Woodland Research Northwest, LLC

Rogers, Arkansas, United States

The Parkinson's and Movement Disorder Institute

Fountain Valley, California, United States

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

Los Angeles, California, United States

SC3 Research - Beverly

Los Angeles, California, United States

SC3 Research Pasadena

Pasadena, California, United States

Neurology of Central Florida Research Center

Altamonte Springs, Florida, United States

JEM Research Institute

Atlantis, Florida, United States

Parkinson's Disease And Movement Disorder Center Of Boca Raton

Boca Raton, Florida, United States

Innovative Research Of West Florida, Inc.

Clearwater, Florida, United States

Infinity Clinical Research, Llc

Hollywood, Florida, United States

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Homestead Associates in Research, Inc.

Miami, Florida, United States

USF Carol and Frank Morsani Center for Advanced Healthcare

Tampa, Florida, United States

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

Tampa, Florida, United States

Neurotrials Research, Inc.

Atlanta, Georgia, United States

Brain Health Center, Emory University

Atlanta, Georgia, United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

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

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Louisville, Movement Disorder Clinic

Louisville, Kentucky, United States

QUEST Research Institute

Farmington Hills, Michigan, United States

University Nebraska Medical Center

Omaha, Nebraska, United States

Dent Neurological Institute

Amherst, New York, United States

South Shore Neurology Associates, Inc.

Patchogue, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Richmond Behavioral Associates

Staten Island, New York, United States

Duke University Health System

Durham, North Carolina, United States

American Clinical Research Institute LLC

Beavercreek, Ohio, United States

NeuroScience Research Center

Canton, Ohio, United States

Midwest Clinical Research Center

Dayton, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Houston Methodist Hospital - Movement Disorders Clinic

Houston, Texas, United States

Booth Gardner Parkinson's Care Center

Kirkland, Washington, United States

Vaught Neurological Services, PLLC

Crab Orchard, West Virginia, United States

Universitaetsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Velocity Clinical Research Germany GmbH

Wiesbaden, Hesse, Germany

Zentrum for klinische Forschung Dr. med. Irma Schoell

Bad Homburg, , Germany

Pharmakologisches Studienzentrum Chemnitz

Chemnitz, , Germany

University Hospital Duesseldorf

Düsseldorf, , Germany

Klinik Haag i. OB

Haag, , Germany

CRC Core Facility Medizinische Hochschule Hannover (MHH)

Hanover, , Germany

DKD HELIOS Klinik Wiesbaden

Wiesbaden, , Germany

Klinikum der Julius-Maximilians-Universitaet Wuerzburg

Würzburg, , Germany

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

Katowice, Silesian Voivodeship, Poland

Medicover Integrated Clinical Services (MICS) Centrum Medyczne Bydgoszcz

Bydgoszcz, , Poland

NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis

Katowice, , Poland

Centrum Medyczne Plejady

Krakow, , Poland

Specjalistyczne Gabinety Sp. z o.o

Krakow, , Poland

Landa Specjalistyczne Gabinety Lekarskie

Krakow, , Poland

Krakowska Akademia Neurologii Sp. z o.o

Krakow, , Poland

Linden Centrum Medyczne

Krakow, , Poland

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

Lublin, , Poland

Centrum Zdrowia I Urody Maxxmed

Lublin, , Poland

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

Plewiska, , Poland

Rivermed Sp z o.o

Poznan, , Poland

ETG Neuroscience

Warsaw, , Poland

MD Clinic Praga Spolka z o. o.

Warsaw, , Poland

Hospital Universitario Virgen Macarena-merge

Seville, Andalusia, Spain

CAE Oroitu (Centro de Atencion Especializada)

Getxo, Vizcaya, Spain

Hospital de Cruces

Barakaldo, , Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Policlinica Gipuzkoa

Donostia / San Sebastian, , Spain

Hospital Universitario de La Princesa

Madrid, , Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, , Spain

Countries

United States; Germany; Poland; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-002463-61

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

JZP385-201

Identifier Type: -

Identifier Source: org_study_id