What side effects are associated with this type of intervention?

Common treatments for Essential Tremor (ET) include beta-blockers like propranolol, anticonvulsants such as primidone, and other agents like topiramate and gabapentin. Beta-blockers may cause fatigue, dizziness, and depression. Primidone can lead to sedation, nausea, and balance issues. Topiramate may cause cognitive side effects, weight loss, and paresthesia. Gabapentin can cause dizziness, fatigue, and peripheral edema. These side effects should be considered when selecting a treatment plan for ET.

What prior FDA approvals exist?

Essential Tremor (ET) is commonly treated with medications such as propranolol, a beta-blocker, and primidone, an anticonvulsant. These drugs help manage symptoms by targeting neural pathways involved in tremor generation. Other treatments include gabapentin and topiramate, which are also anticonvulsants. The novel agent JZP385, currently under study, represents a new approach in targeting these neural pathways, potentially offering an alternative for patients with moderate to severe ET.

What other types of research exist?

While the provided context does not directly mention alternatives specifically for Essential Tremor, some promising pharmacological agents targeting neural pathways that could be considered include: 1) Neuronal nicotinic receptor agonists, which have shown potential in improving motor function in Parkinson's disease models. 2) NMDA receptor antagonists like CHF3381, which have demonstrated antihyperalgesic effects and might be explored for their impact on tremor. These agents could be discussed with a healthcare provider for their potential applicability to ET treatment.

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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.

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

Summary

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.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline to Week 12 on the TETRAS composite outcome score as summarized by each dose of JZP385 and placebo

Secondary study objectives

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.

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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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

JZP385

2021

Completed Phase 2

~420

0 / 8Eligibility criteria met

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.