JZP385-201 Phase 2b Study
Essential Tremor
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
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, 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:
- 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 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.
- 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.
- 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, 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.
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
Experimental
Experimental
Experimental
Placebo Comparator
10 milligram (mg) JZP385
20 mg JZP385
30 mg JZP385
Placebo
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.