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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05122650
Other study ID # JZP385-201
Secondary ID 2020-002463-61
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date December 6, 2021
Est. completion date May 31, 2024

Study information

Verified date May 2024
Source Jazz Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 420
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany Zentrum for klinische Forschung Dr. med. Irma Schoell Bad Homburg
Germany Pharmakologisches Studienzentrum Chemnitz Chemnitz
Germany University Hospital Duesseldorf Dusseldorf
Germany Klinik Haag i. OB Haag
Germany CRC Core Facility Medizinische Hochschule Hannover (MHH) Hannover
Germany Universitaetsklinikum Ulm Ulm Baden-Württemberg
Germany DKD HELIOS Klinik Wiesbaden Wiesbaden
Germany Velocity Clinical Research Germany GmbH Wiesbaden Hessen
Germany Klinikum der Julius-Maximilians-Universitaet Wuerzburg Wuerzburg
Poland Medicover Integrated Clinical Services (MICS) Centrum Medyczne Bydgoszcz Bydgoszcz
Poland Neuro-Care Sp. Z.o.o. sp. Komandytowa Katowice Slaskie
Poland NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis Katowice
Poland Centrum Medyczne Plejady Krakow
Poland Krakowska Akademia Neurologii Sp. z o.o Krakow
Poland Landa Specjalistyczne Gabinety Lekarskie Krakow
Poland Linden Centrum Medyczne Krakow
Poland Specjalistyczne Gabinety Sp. z o.o Krakow
Poland Centrum Zdrowia I Urody Maxxmed Lublin
Poland Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) Neuromed M. i M. Nastaj Spolka Partnerska( Sp.P.) 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
Spain Hospital de Cruces Barakaldo
Spain Hospital Clinic i Provincial de Barcelona Barcelona
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain CAE Oroitu (Centro de Atencion Especializada) Getxo Vizcaya
Spain Hospital Universitario de La Princesa Madrid
Spain Hospital Universitario Ramon y Cajal Madrid
Spain Hospital Universitario Puerta de Hierro de Majadahonda Majadahonda
Spain Policlinica Gipuzkoa San Sebastian
Spain Hospital Universitario Virgen Macarena-merge Sevilla Andalucia
United States Neurology of Central Florida Research Center Altamonte Springs Florida
United States Dent Neurological Institute Amherst New York
United States Brain Health Center, Emory University Atlanta Georgia
United States Neurotrials Research, Inc. Atlanta Georgia
United States JEM Research Institute Atlantis Florida
United States American Clinical Research Institute LLC Beavercreek Ohio
United States Pillar Clinical Research, LLC Bentonville Arkansas
United States The University Of Alabama At Birmingham (Uab) Birmingham Alabama
United States Parkinson's Disease And Movement Disorder Center Of Boca Raton Boca Raton Florida
United States NeuroScience Research Center Canton Ohio
United States Northwestern University - Feinberg School of Medicine - ParkinsonÃ'¿s Disease and Movement Disorders Center Chicago Illinois
United States Innovative Research Of West Florida, Inc. Clearwater Florida
United States Vaught Neurological Services, PLLC Crab Orchard West Virginia
United States Midwest Clinical Research Center Dayton Ohio
United States Duke University Health System Durham North Carolina
United States QUEST Research Institute Farmington Hills Michigan
United States The Parkinson's and Movement Disorder Institute Fountain Valley California
United States Infinity Clinical Research, Llc Hollywood Florida
United States Hawaii Pacific Neuroscience Honolulu Hawaii
United States Houston Methodist Hospital - Movement Disorders Clinic Houston Texas
United States Clinical Neuroscience Solutions, Inc. Jacksonville Florida
United States University of Kansas Medical Center Kansas City Kansas
United States Booth Gardner Parkinson's Care Center Kirkland Washington
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 University of Louisville, Movement Disorder Clinic Louisville Kentucky
United States Homestead Associates in Research, Inc. Miami Florida
United States Vanderbilt University Medical Center Nashville Tennessee
United States University Nebraska Medical Center Omaha Nebraska
United States SC3 Research Pasadena Pasadena California
United States South Shore Neurology Associates, Inc. Patchogue New York
United States Arizona Neuroscience Research, LLC Phoenix Arizona
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 University of Rochester Medical Center Rochester New York
United States Woodland Research Northwest, LLC Rogers Arkansas
United States Imaging Endpoints II, LLC Scottsdale Arizona
United States Movement Disorders Center of Arizona Scottsdale Arizona
United States Richmond Behavioral Associates Staten Island New York
United States Banner Sun Health Research Institute Sun City Arizona
United States University of South Florida Parkinson's Disease and Movement Disorders Center Tampa Florida
United States USF Carol and Frank Morsani Center for Advanced Healthcare Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Jazz Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Proportion 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). Change from Baseline to Week 12
Secondary Proportion of Participants Reported as Much Improved on the Clinical Global Impression of Change (CGI-C) 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). Week 12
Secondary 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). Week 12
Secondary 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 higher scores representing more severe ET. Change from baseline to week 12
Secondary 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. Change from baseline to week 12
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 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. Change from baseline to week 12
Secondary 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. Change from baseline to week 12
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 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) and a total score, plus 3 additional items relating to sexual function and satisfaction with tremor control and medication side effects. Each item is rated by frequency on a scale from 0 (never) to 4 (always), with higher scores indicating greater dissatisfaction or disability due to ET. Change from baseline to week 12
Secondary Change from Baseline to Week 12 on the Essential Tremor Embarrassment Assessment (ETEA) 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. Participants provide a simple response (disagree or agree) to each of the 14-items, the sum of which yields an initial score (Score A, range = 0 to 14). Participants then 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 (Score B, range = 0 to 70). Higher scores on both the simple and nuanced responses indicate greater embarrassment. Change from Baseline to Week 12
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