NCT05122650

A Study To Assess the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor (ET)

A Phase 2b, 12-week, Double-blind, Placebo-controlled, Randomized, Parallel Group, Multicenter Study of the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a 12-week, double-blind, placebo-controlled, randomized, parallel-group, multicenter study of the safety and efficacy of JZP385 in the treatment of adult participants with moderate to severe ET.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DRUG	JZP385	JZP385 capsules will be administered orally (PO) once daily in the morning on an empty stomach for 12 weeks.
OTHER	Placebo	Placebo capsules will be administered orally (PO) once daily in the morning on an empty stomach for 12 weeks.

Timeline

• Start date: 2021-12-06
• Primary completion: 2024-05-30
• Completion: 2024-05-30
• First posted: 2021-11-17
• Last updated: 2025-07-24
• Results posted: 2025-07-24

Locations

73 sites across 4 countries: United States, Germany, Poland, Spain

Regulatory

• FDA-regulated drug study