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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.
Select...
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.
Find a Location
Who is running the clinical trial?
Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
33,939 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What negative effects has JZP385 been known to induce in test subjects?
"JZP385's safety is only supported by Phase 2 trial data, which means that while there are some studies indicating it is safe, none have shown that it is effective. Therefore, we've given it a score of 2."
Answered by AI
Does this clinical trial have an age limit? If so, what is the maximum age of patients who are being accepted into the study?
"This trial is only eligible for patients that are between 18-80 years old. If you are under 18, there is 1 clinical trial available and if you're over 65, there are 52 trials open to you."
Answered by AI
Why was this clinical trial designed, and what goals does it hope to achieve?
"According to the trial's sponsor, Jazz Pharmaceuticals, the primary outcome will be change from baseline to week 12 on the TETRAS composite outcome score. This will be measured for each dose of JZP385 and placebo. Additionally, this study will secondary outcomes including change from baseline to week 12 on the Essential tremor Embarrassment Assessment (defined as a 14-item questionnaire assessing embarrassment related to tremor), CGI-S (a 5-point scale measuring severity of ability to function due to ET), and TETRAS-PS (a clinical rating scale that quantifies tremor in different parts of the body)."
Answered by AI
Is this study actively recruiting new participants?
"That is correct. According to the information provided on clinicaltrials.gov, this study was originally posted December 6th, 2021 and is currently seeking 400 individuals from 24 different locations."
Answered by AI
To be eligible for this research, what are the inclusivity criteria?
"This study is for patients with essential tremor between the ages of 18-80. Up to 400 individuals can take part in the clinical trial."
Answered by AI
In how many different physical sites is this trial being run today?
"Currently, this clinical trial is enrolling patients at 24 sites across the country. Some of these locations include Atlanta, Bentonville and Kansas City. If you are interested in enrolling, it might be helpful to select the location that is closest to you in order to minimize travel demands."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
Texas
Florida
Other
How old are they?
18 - 65
What site did they apply to?
Homestead Associates in Research, Inc.
Richmond Behavioral Associates
University of Kansas Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
1
2
0
Why did patients apply to this trial?
Currently have essential tremor and current prescription of Propanolol (80mg) is not fully working.
PatientReceived 1 prior treatment
I have shaking hands, making it difficult to eat with a fork and drinking from a cup. Also, when trying to do intracule close work with the hands.
PatientReceived 1 prior treatment
I’ve tried propranolol and primedone and the side effects are unacceptable. The condition is slowly getting worse and I work in a lab where I’m required to do some manual work.
PatientReceived 1 prior treatment
I have struggled with worsening essential tremors for over a decade. They effect only the hands. I find it impossible to write and eating is very difficult. My tremors have not responded to Primadone or Gabapentin.
PatientReceived 2+ prior treatments
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