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.

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.