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    Summary
    EudraCT Number:2020-002463-61
    Sponsor's Protocol Code Number:JZP385-201
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-26
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-002463-61
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of JZP385 in Adults with Moderate to Severe Essential Tremor (ET)
    A.4.1Sponsor's protocol code numberJZP385-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05122650
    A.5.4Other Identifiers
    Name:INDNumber:130296
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCavion, Inc., a subsidiary of Jazz Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCavion, Inc., a subsidiary of Jazz Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJazz Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointMedical Monitor for JZP385-201
    B.5.3 Address:
    B.5.3.1Street Address3170 Porter Drive
    B.5.3.2Town/ cityPalo Alto, CA
    B.5.3.3Post code94304
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16504963777
    B.5.6E-mailEU&RoW.ClinicalTrialsMailbox@jazzpharma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code CX-8998
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSuvecaltamide
    D.3.9.1CAS number 2249709-38-2
    D.3.9.2Current sponsor codeJZP385
    D.3.9.4EV Substance CodeSUB216125
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code CX-8998
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSuvecaltamide
    D.3.9.1CAS number 2249709-38-2
    D.3.9.2Current sponsor codeJZP385
    D.3.9.4EV Substance CodeSUB216125
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Essential Tremor (ET)
    E.1.1.1Medical condition in easily understood language
    Essential tremor is a nervous system (neurological) disorder that causes
    involuntary and rhythmic shaking
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10015496
    E.1.2Term Essential tremor
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of JZP385 to improve the functional impact of tremor when administered once daily for up to 12 weeks at fixed doses of 10, 20, and 30 mg/day.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of JZP385 to improve the clinician’s assessment of the ability to function due to ET when administered once daily for up to 12 weeks at fixed doses of 10, 20, and 30 mg/day.

    To evaluate the efficacy of JZP385 to improve overall ET when administered once daily for up to 12 weeks at fixed doses of 10, 20, and 30 mg/day.

    To evaluate the safety and tolerability of JZP385 administered once daily for up to 12 weeks at fixed doses of 10, 20, and 30 mg/day in the treatment of adult participants with ET.
    E.2.3Trial contains a sub-study No
    E.3Principal 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 score of > 5 on the sum of items 6 and 7 of the TETRAS-PS; 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.
    E.4Principal exclusion criteria
    1. Known history or current evidence of other medical or neurological conditions that may cause or explain the participant's tremor.
    2. 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 questionaries) 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. Nicotine use disorder is excluded if it impacts tremor.
    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 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 or nonprescription drugs or other products known to be inducers of CYP3A4 that are known to decrease AUC by >30% (eg, primidone), 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 and histamine-2 receptor antagonists, which 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 apart from 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.
    E.5 End points
    E.5.1Primary end point(s)
    -Difference in the mean Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) composite outcome score(a) from Baseline to Week 12 between each dose of JZP385 and placebo.

    (a) The TETRAS composite outcome score consists of the sum of modified items 1 to 11 of the TETRAS Activities of Daily Living (TETRAS-ADL) subscale and modified items 6 and 7 of the TETRAS Performance Subscale (TETRAS-PS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline and week 12
    E.5.2Secondary end point(s)
    Efficacy
    -Difference in the proportion of participants who improved (≥ 1-point improvement) from Baseline to Week 12 on the CGI-S, between each dose of JZP385 and placebo
    -Proportion of participants reported as much improved at Week 12 relative to baseline on the:
    -Clinical Global Impression of Change (CGI-C)
    -Patient Global Impression of Change (PGI-C)
    -Change from Baseline to Week 12, as summarized by each dose of JZP385 and placebo, on the:
    -TETRAS-ADL
    -TETRAS-PS
    -Upper limb score (item 4) of the TETRAS-PS
    -TETRAS total score
    -Quality of Life in Essential Tremor (QUEST)
    -Essential Tremor Embarrassment Assessment (ETEA)

    Safety
    The occurrence of and/or change in:
    -Treatment-emergent adverse events (TEAEs)
    -Safety laboratory assessments
    -Vital signs
    -12-lead electrocardiogram (ECG)
    -Columbia Suicide Severity Rating Scale (C-SSRS)
    -Physical exam

    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline to week 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Germany
    Poland
    Spain
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 297
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 103
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 309
    F.4.2.2In the whole clinical trial 400
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-13
    P. End of Trial
    P.End of Trial StatusOngoing
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