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NCT03319485 · ClinicalTrials.gov registry record · NA
ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease
A NA study of Parkinson Disease, sponsored by InSightec.
- Active
- Registry status
- NA
- Development phase
- 92
- Enrollment target
- 20
- Study locations
NCT03319485: Active NA study of Parkinson Disease, sponsored by InSightec.
NCT03319485 is a NA study of Parkinson Disease that is active but no longer recruiting, run by InSightec. The registered enrollment target is 92 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03319485, a NA study of Parkinson Disease, is active but no longer recruiting, sponsored by InSightec.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 92 participants
- Enrollment target
- 20
- Study locations
Study Summary
Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.
Primary Outcome
Responder is defined as the patient reaching a minimally clinically significant difference on: 1. UDysRS (this measures dyskinesia and their impact) OR 2. MDS-UPDRS Part III Motor Exam -Total score (this measures overall motor fluctuations).
Conditions Studied
Interventions
- DEVICE ExAblate Pallidotomy
- DEVICE Sham ExAblate Pallidotomy
Study Locations (20)
Other
- Rambam Health Care - Haifa
- Fondazione IRCCS Neurological Institute Carlo Besta - Milan
- Azienda Ospedaliera Universitaria di Verona, Univerista di Verona - Verona
- Severance Hospital, Yonsei University Health System - Seoul
- Chang Bing Show Chwan Memorial Hospital - Changhua
- St. Mary's Hospital - London
New York
- New York University Health Langone - New York
- Weill Cornell Medicine - New York
California
- Stanford University Medical Center - Stanford
Florida
- Palm Beach Neuroscience Institute/Sperling Medical Group - Boynton Beach
Maryland
- University of Maryland Medical System - Baltimore
Massachusetts
- Brigham and Women's Hospital - Boston
Minnesota
- Mayo Clinic - Rochester
Ohio
- The Ohio State Wexner Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2018-02-09 |
| Est. Completion | 2026-08-31 |
| Phase | NA |
What the registry record for NCT03319485 still lists
NCT03319485 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions - of which ExAblate Pallidotomy is the first listed.
NCT03319485 names 20 study sites across 14 states, led by Other, New York, California.
Frequently Asked Questions
What is clinical trial NCT03319485 about?
NCT03319485 is a clinical study titled "ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease". Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.
What is the current status of trial NCT03319485?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 92 participants. The study started on 2018-02-09. Estimated completion is 2026-08-31.
What conditions does trial NCT03319485 study?
This clinical trial studies the following conditions: Parkinson Disease.
What interventions are being tested in trial NCT03319485?
The interventions under investigation include: ExAblate Pallidotomy (DEVICE), Sham ExAblate Pallidotomy (DEVICE).
Who is sponsoring clinical trial NCT03319485?
This trial is sponsored by InSightec, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03319485 being conducted?
This trial has 20 study locations across California, Florida, Maryland, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Parkinson Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03319485's enrollment target sits among peer trials
92 96th of 297 higher than 202 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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