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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
Study 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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
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 moreTrial 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.
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Who is running the clinical trial?
Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
33,929 Total Patients Enrolled
2 Trials studying Essential Tremor
114 Patients Enrolled for Essential Tremor
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I can stop using proton pump inhibitors 2 weeks before the study starts.I am not using drugs or products that strongly affect my liver enzymes and can stop them if needed before the study starts.I haven't had botulinum toxin for upper limb tremor in the last 6 months.I have a medical condition that could be causing my tremors.I am using or willing to use contraception or a barrier method if I can become pregnant or father a child.I have not had specific brain surgeries or can't stop using a device for my tremor during the study.I am between 18 and 80 years old.I am not pregnant or breastfeeding and, if capable of childbearing, am using effective birth control.I am between 18 and 80 years old.I agree not to donate sperm and to use effective birth control during and 30 days after the study.I have been diagnosed with Essential Tremor according to international standards.I am not using any drugs that strongly affect liver enzymes and can't stop them 4 weeks before the study.I am not pregnant or breastfeeding, and if capable of childbearing, I use effective birth control.I agree to follow the study's rules about sperm donation and use of condoms.You have been diagnosed with a substance use disorder, drug dependence, or seeking treatment for alcohol or substance abuse in the past 2 years.I have been on the same antitremor medication dose for at least 6 weeks.You cannot take certain medications or substances that could cause shaking or affect the evaluation of shaking during study visits. This includes medications for congestion, asthma, and alcohol.You have significant problems with memory and thinking, or you may have difficulty understanding and participating in the study.You have significant difficulty with tremors that affects your daily activities and your ability to function.You have had thoughts of hurting yourself or have attempted suicide in the past 24 months, or you have experienced a major depressive episode in the past year according to specific mental health criteria.You have significant difficulty with tremors that affects your ability to function in daily life.I have been diagnosed with Essential Tremor according to international standards.You have significant difficulty with tremors, as shown by specific scores on tests, and your ability to function is rated as at least moderate.
Research Study Groups:
This trial has the following groups:- Group 1: 10 milligram (mg) JZP385
- Group 2: 20 mg JZP385
- Group 3: 30 mg JZP385
- Group 4: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Essential Tremor Patient Testimony for trial: Trial Name: NCT05122650 — Phase 2
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