Essential Tremor (ET) MedDRA version: 21.1 Level: PT Classification code 10015496 Term: Essential tremor System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Code: CX-8998
Pharmaceutical Form: Capsule
INN or Proposed INN: Suvecaltamide
CAS Number: 2249709-38-2
Current Sponsor code: JZP385
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
Cavion, Inc., a subsidiary of Jazz Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent. 2. Participants who are diagnosed with ET (including ET plus) according to the MDS Consensus Statement on the Classification of Tremors from the Task Force on Tremor of the International Parkinson's and Movement Disorder Society. 3. Participants have moderate to severe disability associated with tremor as determined by a score of = 22 on the TETRAS-ADL subscale; and a 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 =65 years) yes F.1.3.1 Number of subjects for this age range 103
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. Severe cognitive impairment as defined by a Montreal Cognitive Assessment (MoCA; score 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 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 before and 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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. ;Primary 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). ;Timepoint(s) of evaluation of this end point: baseline and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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 ;Timepoint(s) of evaluation of this end point: baseline to week 12 | — |
Countries
Germany, Poland, Spain, United States
Contacts
Public ContactMedical Monitor for JZP385-201
Jazz Pharmaceuticals, Inc.
Outcome results
None listed