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NCT05122650 · ClinicalTrials.gov registry record · Phase 2
A Study To Assess the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor (ET)
A Phase 2 study of Essential Tremor, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 420
- Enrollment target
- 20
- Study locations
NCT05122650: Completed Phase 2 study of Essential Tremor, sponsored by Jazz Pharmaceuticals.
NCT05122650 is a Phase 2 study of Essential Tremor that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 420 participants, roughly in line with the 392-participant average among 41 other Essential Tremor trials with a reported enrollment target. The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05122650, a Phase 2 study of Essential Tremor, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 420 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The TETRAS composite outcome score is the sum of modified items 1 - 11 of the TETRAS-ADL subscale and modified items 6 - 7 of the TETRAS-PS. The TETRAS-ADL subscale is a patient-rated scale administered by a trained interviewer that assesses the impact of tremor on day-to-day functioning, such as eating, drinking, dressing, and other fine motor skills. The TETRAS-PS is a clinical rating scale that quantifies tremor in the head, face voice, limbs and trunk. Items 6 (drawing an Archimedes spiral u
Conditions Studied
Interventions
- OTHER Placebo
- DRUG JZP385
Study Locations (20)
Florida
- Neurology of Central Florida Research Center - Altamonte Springs
- JEM Research Institute - Atlantis
- Parkinson's Disease And Movement Disorder Center Of Boca Raton - Boca Raton
- Innovative Research Of West Florida, Inc. - Clearwater
- Infinity Clinical Research, Llc - Hollywood
- Clinical Neuroscience Solutions, Inc. - Jacksonville
- Homestead Associates in Research, Inc. - Miami
- USF Carol and Frank Morsani Center for Advanced Healthcare - Tampa
Arizona
- St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center - Phoenix
- Arizona Neuroscience Research, LLC - Phoenix
- Imaging Endpoints II, LLC - Scottsdale
- Movement Disorders Center of Arizona - Scottsdale
- Banner Sun Health Research Institute - Sun City
California
- The Parkinson's and Movement Disorder Institute - Fountain Valley
- Keck School of Medicine USC - Healthcare Consultation Center 2 (HCCII) - Los Angeles
- SC3 Research - Beverly - Los Angeles
- SC3 Research Pasadena - Pasadena
Arkansas
- Pillar Clinical Research, LLC - Bentonville
- Woodland Research Northwest, LLC - Rogers
Alabama
- The University Of Alabama At Birmingham (Uab) - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2021-12-06 |
| Est. Completion | 2024-05-30 |
| Phase | Phase 2 |
What the finished NCT05122650 record still lists
NCT05122650 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 392-participant average among 41 other Essential Tremor trials with a reported enrollment target.
The record links to 1 condition, with Essential Tremor appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05122650 names 20 study sites across 5 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT05122650 about?
NCT05122650 is a clinical study titled "A Study To Assess the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor (ET)". 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.
What is the current status of trial NCT05122650?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 420 participants. The study started on 2021-12-06. Estimated completion is 2024-05-30.
What conditions does trial NCT05122650 study?
This clinical trial studies the following conditions: Essential Tremor.
What interventions are being tested in trial NCT05122650?
The interventions under investigation include: Placebo (OTHER), JZP385 (DRUG).
Who is sponsoring clinical trial NCT05122650?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05122650 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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