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JZP385-201 Phase 2b Study

Primary Purpose

Essential Tremor

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JZP385
Placebo
Sponsored by
Jazz Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Tremor focused on measuring JZP385, T-type calcium channels, Movement disorder, Tremor, Moderate to severe essential tremor

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, over the same 30 day period.

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.

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 affect the evaluation of tremor within 2 weeks or 5 half-lives (whichever is longer) before screening or planned use at any time during 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%, 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, 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.

Sites / Locations

  • The University Of Alabama At Birmingham (Uab)Recruiting
  • St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease CenterRecruiting
  • Arizona Neuroscience Research, LLCRecruiting
  • Imaging Endpoints II, LLCRecruiting
  • Movement Disorders Center of ArizonaRecruiting
  • Banner Sun Health Research InstituteRecruiting
  • Pillar Clinical Research, LLC
  • Woodland Research Northwest, LLC
  • The Parkinson's and Movement Disorder InstituteRecruiting
  • Keck School of Medicine USC - Healthcare Consultation Center 2 (HCCII)Recruiting
  • SC3 Research - Beverly
  • SC3 Research PasadenaRecruiting
  • Neurology of Central Florida Research CenterRecruiting
  • JEM Research Institute
  • Parkinson's Disease And Movement Disorder Center Of Boca RatonRecruiting
  • Innovative Research Of West Florida, Inc.Recruiting
  • Infinity Clinical Research, LlcRecruiting
  • Clinical Neuroscience Solutions, Inc.Recruiting
  • Homestead Associates in Research, Inc.Recruiting
  • USF Carol and Frank Morsani Center for Advanced HealthcareRecruiting
  • University of South Florida Parkinson's Disease and Movement Disorders CenterRecruiting
  • Neurotrials Research, Inc.Recruiting
  • Brain Health Center, Emory University
  • Hawaii Pacific NeuroscienceRecruiting
  • Northwestern University - Feinberg School of Medicine - ParkinsonÃ'¿s Disease and Movement Disorders CenterRecruiting
  • University of Kansas Medical CenterRecruiting
  • University of Louisville, Movement Disorder ClinicRecruiting
  • QUEST Research InstituteRecruiting
  • University Nebraska Medical Center
  • Dent Neurological InstituteRecruiting
  • South Shore Neurology Associates, Inc.Recruiting
  • University of Rochester Medical CenterRecruiting
  • Richmond Behavioral AssociatesRecruiting
  • Duke University Health SystemRecruiting
  • American Clinical Research Institute LLC
  • NeuroScience Research CenterRecruiting
  • Midwest Clinical Research Center
  • Vanderbilt University Medical Center
  • Houston Methodist Hospital - Movement Disorders ClinicRecruiting
  • Booth Gardner Parkinson's Care CenterRecruiting
  • Vaught Neurological Services, PLLCRecruiting
  • Universitaetsklinikum UlmRecruiting
  • Velocity Clinical Research Germany GmbHRecruiting
  • Zentrum for klinische Forschung Dr. med. Irma SchoellRecruiting
  • Pharmakologisches Studienzentrum ChemnitzRecruiting
  • University Hospital DuesseldorfRecruiting
  • St. Josef-Krankenhaus Essen-Kupferdreh
  • Klinik Haag i. OBRecruiting
  • CRC Core Facility Medizinische Hochschule Hannover (MHH)Recruiting
  • DKD HELIOS Klinik WiesbadenRecruiting
  • Klinikum der Julius-Maximilians-Universitaet Wuerzburg
  • Neuro-Care Sp. Z.o.o. sp. k.
  • Medicover Integrated Clinical Services (MICS) Centrum Medyczne BydgoszczRecruiting
  • NZOZ Wielospecjalistyczna Poradnia Lekarska SynapsisRecruiting
  • Centrum Medyczne PlejadyRecruiting
  • Specjalistyczne Gabinety Sp. z o.o
  • Landa Specjalistyczne Gabinety LekarskieRecruiting
  • Krakowska Akademia Neurologii Sp. z o.oRecruiting
  • Linden Centrum MedyczneRecruiting
  • Osrodek Badan Klinicznych Appletreeclinics
  • Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) Neuromed M. i M. Nastaj Spolka Partnerska( Sp.P.)Recruiting
  • Centrum Zdrowia I Urody MaxxmedRecruiting
  • Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki HertmanowskiejRecruiting
  • Rivermed Sp z o.oRecruiting
  • SINGUA SP. z o.o.Recruiting
  • MD Clinic Praga Spolka z o. o.Recruiting
  • Hospital Universitario Virgen Macarena-mergeRecruiting
  • CAE Oroitu (Centro de Atencion Especializada)Recruiting
  • Hospital de CrucesRecruiting
  • Hospital Clinic i Provincial de BarcelonaRecruiting
  • Hospital de la Santa Creu i Sant PauRecruiting
  • Hospital Universitario de La PrincesaRecruiting
  • Hospital Universitario Ramon y CajalRecruiting
  • Hospital Universitario Puerta de Hierro de Majadahonda
  • Clinica Universidad de NavarraRecruiting
  • Policlinica GipuzkoaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

10 milligram (mg) JZP385

20 mg JZP385

30 mg JZP385

Placebo

Arm Description

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

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.

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.

Participants will receive placebo from Day 1.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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).
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 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 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 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 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 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.

Full Information

First Posted
November 2, 2021
Last Updated
October 23, 2023
Sponsor
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05122650
Brief Title
JZP385-201 Phase 2b 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
November 13, 2023 (Anticipated)
Study Completion Date
December 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jazz Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
JZP385, T-type calcium channels, Movement disorder, Tremor, Moderate to severe essential tremor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
10 milligram (mg) JZP385
Arm Type
Experimental
Arm Description
Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.
Arm Title
20 mg JZP385
Arm Type
Experimental
Arm Description
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.
Arm Title
30 mg JZP385
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo from Day 1.
Intervention Type
Drug
Intervention Name(s)
JZP385
Intervention Description
JZP385 capsules will be administered orally (PO) once daily in the morning on an empty stomach for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules will be administered orally (PO) once daily in the morning on an empty stomach for 12 weeks.
Primary Outcome Measure Information:
Title
Change from Baseline to Week 12 on the TETRAS composite outcome score as summarized by each dose of JZP385 and placebo
Description
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.
Time Frame
Change from baseline to week 12
Secondary Outcome Measure Information:
Title
Proportion of Participants who Improved (≥ 1-Point Improvement) from Baseline to Week 12 on the Clinical Global Impression- Severity scale (CGI-S)
Description
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).
Time Frame
Change from Baseline to Week 12
Title
Proportion of Participants Reported as Much Improved on the Clinical Global Impression of Change (CGI-C)
Description
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).
Time Frame
Week 12
Title
Proportion of Participants Reported as Much Improved on the Patient Global Impression of Change (PGI-C) at Week 12
Description
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).
Time Frame
Week 12
Title
Change from Baseline to Week 12 on the TETRAS-ADL subscale as Summarized by Each Dose of JZP385 and Placebo
Description
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.
Time Frame
Change from baseline to week 12
Title
Change from Baseline to Week 12 on the TETRAS-PS Subscale as Summarized by Each Dose of JZP385 and Placebo
Description
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.
Time Frame
Change from baseline to week 12
Title
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
Description
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.
Time Frame
Change from baseline to week 12
Title
Change from Baseline to Week 12 on the TETRAS Total Score, as Summarized by Each Dose of JZP385 and Placebo.
Description
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.
Time Frame
Change from baseline to week 12
Title
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
Description
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.
Time Frame
Change from baseline to week 12
Title
Change from Baseline to Week 12 on the Essential Tremor Embarrassment Assessment (ETEA) as Summarized by Each Dose of JZP385 and Placebo
Description
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.
Time Frame
Change from Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Director Clinical Trial Disclosure & Transparency
Phone
215-832-3750
Email
ClinicalTrialDisclosure@JazzPharma.com
Facility Information:
Facility Name
The University Of Alabama At Birmingham (Uab)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
205-801-8000
Facility Name
St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
602-406-8040
Facility Name
Arizona Neuroscience Research, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
602-835-2429
Ext
143
Facility Name
Imaging Endpoints II, LLC
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
480-779-3997
Facility Name
Movement Disorders Center of Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
480-526-5441
Facility Name
Banner Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
623-832-5726
Facility Name
Pillar Clinical Research, LLC
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Individual Site Status
Completed
Facility Name
Woodland Research Northwest, LLC
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Individual Site Status
Completed
Facility Name
The Parkinson's and Movement Disorder Institute
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
714-378-5074
Facility Name
Keck School of Medicine USC - Healthcare Consultation Center 2 (HCCII)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
323-442-5814
Facility Name
SC3 Research - Beverly
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Completed
Facility Name
SC3 Research Pasadena
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
626-250-2070
Ext
774
Facility Name
Neurology of Central Florida Research Center
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32714
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
407-790-4990
Ext
4
Facility Name
JEM Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Parkinson's Disease And Movement Disorder Center Of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
561-392-1818
Ext
2
Facility Name
Innovative Research Of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
727-584-6368
Facility Name
Infinity Clinical Research, Llc
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
954-366-0277
Ext
123
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
33217
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
904-281-5757
Facility Name
Homestead Associates in Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
305-245-0873
Facility Name
USF Carol and Frank Morsani Center for Advanced Healthcare
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
813-974-2028
Facility Name
University of South Florida Parkinson's Disease and Movement Disorders Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
813-974-8026
Facility Name
Neurotrials Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
404-851-9934
Facility Name
Brain Health Center, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Hawaii Pacific Neuroscience
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
808-564-6141
Facility Name
Northwestern University - Feinberg School of Medicine - ParkinsonÃ'¿s Disease and Movement Disorders Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
312-503-6950
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
913-588-6921
Facility Name
University of Louisville, Movement Disorder Clinic
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
502-540-3585
Facility Name
QUEST Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
248-957-8940
Facility Name
University Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
402-552-6233
Facility Name
Dent Neurological Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
716-819-4117
Facility Name
South Shore Neurology Associates, Inc.
City
Patchogue
State/Province
New York
ZIP/Postal Code
11772
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
631-758-1910
Ext
2246
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
585-341-7579
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10314
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
718-317-5522
Ext
1313
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
919-668-2905
Facility Name
American Clinical Research Institute LLC
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
312-871-0274
Facility Name
NeuroScience Research Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
330-244-2542
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Individual Site Status
Completed
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
615-421-2845
Facility Name
Houston Methodist Hospital - Movement Disorders Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
346-238-4543
Facility Name
Booth Gardner Parkinson's Care Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
425-899-5413
Facility Name
Vaught Neurological Services, PLLC
City
Crab Orchard
State/Province
West Virginia
ZIP/Postal Code
25827
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
919-449-8343
Facility Name
Universitaetsklinikum Ulm
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
49 731 177 5365
Facility Name
Velocity Clinical Research Germany GmbH
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65189
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
49-(0)611-900590
Facility Name
Zentrum for klinische Forschung Dr. med. Irma Schoell
City
Bad Homburg
ZIP/Postal Code
61350
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
06172-2679573
Facility Name
Pharmakologisches Studienzentrum Chemnitz
City
Chemnitz
ZIP/Postal Code
09111
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
49 3727 9958 151
Facility Name
University Hospital Duesseldorf
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
492118108262
Facility Name
St. Josef-Krankenhaus Essen-Kupferdreh
City
Essen
ZIP/Postal Code
45257
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Klinik Haag i. OB
City
Haag
ZIP/Postal Code
83527
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
4980723769787
Facility Name
CRC Core Facility Medizinische Hochschule Hannover (MHH)
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian
Phone
49 - 511 - 532 3110
Facility Name
DKD HELIOS Klinik Wiesbaden
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
496115776
Facility Name
Klinikum der Julius-Maximilians-Universitaet Wuerzburg
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Completed
Facility Name
Neuro-Care Sp. Z.o.o. sp. k.
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-749
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
0048 793 802 081
Facility Name
Medicover Integrated Clinical Services (MICS) Centrum Medyczne Bydgoszcz
City
Bydgoszcz
ZIP/Postal Code
85-065
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48 728 400 535
Facility Name
NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
602643900
Facility Name
Centrum Medyczne Plejady
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48501076835
Facility Name
Specjalistyczne Gabinety Sp. z o.o
City
Krakow
ZIP/Postal Code
30-539
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
(48)724658862
Facility Name
Landa Specjalistyczne Gabinety Lekarskie
City
Krakow
ZIP/Postal Code
31-156
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48 508 790 106
Facility Name
Krakowska Akademia Neurologii Sp. z o.o
City
Krakow
ZIP/Postal Code
31-505
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
601 426 425
Facility Name
Linden Centrum Medyczne
City
Krakow
ZIP/Postal Code
31-721
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
+48 512 507 454
Facility Name
Osrodek Badan Klinicznych Appletreeclinics
City
Lodz
ZIP/Postal Code
90-349
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) Neuromed M. i M. Nastaj Spolka Partnerska( Sp.P.)
City
Lublin
ZIP/Postal Code
20-064
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48 509 309 344
Facility Name
Centrum Zdrowia I Urody Maxxmed
City
Lublin
ZIP/Postal Code
20-080
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48 797 477 833
Facility Name
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki Hertmanowskiej
City
Plewiska
ZIP/Postal Code
62-064
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48693385905
Facility Name
Rivermed Sp z o.o
City
Poznan
ZIP/Postal Code
61-441
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48692132092
Facility Name
SINGUA SP. z o.o.
City
Warsaw
ZIP/Postal Code
02-777
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48 575 000 193
Facility Name
MD Clinic Praga Spolka z o. o.
City
Warsaw
ZIP/Postal Code
03-505
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
+ 48 600 396 394
Facility Name
Hospital Universitario Virgen Macarena-merge
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34955006627
Facility Name
CAE Oroitu (Centro de Atencion Especializada)
City
Getxo
State/Province
Vizcaya
ZIP/Postal Code
48993
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
0034946559219
Facility Name
Hospital de Cruces
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
946007961
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34-932275780
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34 93 553 7336
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
915202416
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34 91 336 82 63
Facility Name
Hospital Universitario Puerta de Hierro de Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
34 911916118
Facility Name
Clinica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
948255400
Facility Name
Policlinica Gipuzkoa
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
943 00 28 12

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

JZP385-201 Phase 2b Study

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