Phase 2
N=420
A Study To Assess the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor (ET)
Essential Tremor
Bottom Line
View on ClinicalTrials.gov: NCT05122650 ↗Enrolled (actual)
420
Serious AEs
3.4%
Results posted
Jul 2025
Primary outcome: Primary: Change From Baseline to Week 12 on the TETRAS Composite Outcome Score as Summarized by Each Dose of JZP385 and Placebo — -6.3; -5.8; -6.7; -7.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- JZP385 (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jazz Pharmaceuticals
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 on the TETRAS Composite Outcome Score as Summarized by Each Dose of JZP385 and Placebo |
-6.3; -5.8; -6.7; -7.5 | — |
| SECONDARY Percentage of Participants Who Improved (≥ 1-Point Improvement) From Baseline to Week 12 on the Clinical Global Impression- Severity Scale (CGI-S) |
50.0; 49.8; 55.7; 62.8 | — |
| SECONDARY Proportion of Participants Reported as Much Improved on the Clinical Global Impression of Change (CGI-C) at Week 12 |
22; 18; 19; 30 | — |
| SECONDARY Proportion of Participants Reported as Much Improved on the Patient Global Impression of Change (PGI-C) at Week 12 |
16; 11; 20; 32 | — |
| SECONDARY Change From Baseline to Week 12 on the TETRAS-ADL Subscale as Summarized by Each Dose of JZP385 and Placebo |
-6.4; -6.3; -7.1; -8.7 | — |
| SECONDARY Change From Baseline to Week 12 on the TETRAS-PS Subscale as Summarized by Each Dose of JZP385 and Placebo |
-5.4; -5.3; -5.1; -5.5 | — |
| 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 |
-2.3; -2.4; -2.0; -2.4 | — |
| SECONDARY Change From Baseline to Week 12 on the TETRAS Total Score, as Summarized by Each Dose of JZP385 and Placebo. |
-11.8; -11.6; -12.3; -14.4 | — |
| 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 |
-5.5; -3.3; -3.5; -7.8; -5.8; 1.0 | — |
| SECONDARY Change From Baseline to Week 12 on the Essential Tremor Embarrassment Assessment (ETEA) Score A as Summarized by Each Dose of JZP385 and Placebo |
-0.6; -0.5; -0.6; -1.2 | — |
| SECONDARY Change From Baseline to Week 12 on the Essential Tremor Embarrassment Assessment (ETEA) Score B as Summarized by Each Dose of JZP385 and Placebo |
-4.2; -3.5; -4.6; -5.6 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT05122650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.