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Unknown

JZP385 for Essential Tremor

Phase 2
Waitlist Available
Research Sponsored by Jazz Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent
Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent.
Must not have
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 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

Summary

This trial will study whether JZP385 is safe and effective in treating adults with essential tremor.

Who is the study for?
Adults aged 18-80 with moderate to severe Essential Tremor, as indicated by specific tremor scales. They must not be on any medication that could cause tremors or substances like alcohol in excess. Participants should have stable health and agree to use effective contraception during the study.Check my eligibility
What is being tested?
The trial is testing JZP385 against a placebo over 12 weeks to see if it's safe and works for treating Essential Tremor. It's a double-blind study, meaning neither the participants nor the researchers know who gets the real drug or placebo.See study design
What are the potential side effects?
While side effects of JZP385 are not detailed here, common ones for new treatments may include nausea, headache, dizziness, fatigue or allergic reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I am between 18 and 80 years old.
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I have been diagnosed with Essential Tremor according to international standards.
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I have been diagnosed with Essential Tremor according to international standards.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken any medication that could cause shaking in the last 2 weeks or longer.
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I am not using drugs or products that strongly affect my liver enzymes and can stop them if needed before the study starts.
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I haven't had botulinum toxin for upper limb tremor in the last 6 months.
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I have not had specific brain surgeries or can't stop using a device for my tremor during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline to Week 12 on the TETRAS composite outcome score as summarized by each dose of JZP385 and placebo
Secondary outcome measures
Change from Baseline to Week 12 on the Essential Tremor Embarrassment Assessment (ETEA) as Summarized by Each Dose of JZP385 and Placebo
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
Change from Baseline to Week 12 on the TETRAS Total Score, as Summarized by Each Dose of JZP385 and Placebo.
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: 30 mg JZP385Experimental Treatment1 Intervention
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.
Group II: 20 mg JZP385Experimental Treatment1 Intervention
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.
Group III: 10 milligram (mg) JZP385Experimental Treatment1 Intervention
Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive placebo from Day 1.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Essential Tremor (ET) include beta-blockers like propranolol, which work by blocking adrenergic receptors to reduce tremor amplitude, and anticonvulsants like primidone, which modulate GABAergic activity to stabilize neural excitability. Other agents such as topiramate and gabapentin also act on neural pathways to reduce tremor severity. These treatments are crucial for ET patients as they help manage symptoms and improve quality of life. JZP385, a novel pharmacological agent under study, likely targets specific neural pathways involved in ET, potentially offering a new mechanism to control tremor more effectively.

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor
249 Previous Clinical Trials
34,483 Total Patients Enrolled
2 Trials studying Essential Tremor
114 Patients Enrolled for Essential Tremor

Media Library

JZP385 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05122650 — Phase 2
Essential Tremor Research Study Groups: 10 milligram (mg) JZP385, 20 mg JZP385, 30 mg JZP385, Placebo
Essential Tremor Clinical Trial 2023: JZP385 Highlights & Side Effects. Trial Name: NCT05122650 — Phase 2
JZP385 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05122650 — Phase 2
Essential Tremor Patient Testimony for trial: Trial Name: NCT05122650 — Phase 2
~117 spots leftby Jul 2025