JZP385 for Essential Tremor
Recruiting in Palo Alto (17 mi)
+116 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Jazz Pharmaceuticals
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial is testing a new medication called JZP385. It aims to help adults who have moderate to severe essential tremor (ET). The study will check if JZP385 is safe and effective in reducing the symptoms of ET.
Research Team
Eligibility Criteria
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.Inclusion Criteria
I am using or willing to use contraception or a barrier method if I can become pregnant or father a child.
I am between 18 and 80 years old.
I am not pregnant or breastfeeding and, if capable of childbearing, am using effective birth control.
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Exclusion Criteria
You drink more than 4 cups of coffee or consume more than 400 mg of caffeine per day.
You drink more than 3 alcoholic drinks every day on a regular basis.
I haven't taken any medication that could cause shaking in the last 2 weeks or longer.
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Treatment Details
Interventions
- JZP385 (Unknown)
- Placebo (Unknown)
Trial OverviewThe 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.
Participant Groups
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jazz Pharmaceuticals
Lead Sponsor
Trials
252
Recruited
35,100+
Bruce C. Cozadd
Jazz Pharmaceuticals
Chief Executive Officer since 2009
BA in Economics from Yale University, MBA from Stanford University
Dr. Austin
Jazz Pharmaceuticals
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland