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| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P150038 S037/ PAS001 |
| Date Original Protocol Accepted |
03/23/2026
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| Date Current Protocol Accepted |
03/23/2026
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| Study Name |
FREEDOM Study (PD018)
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| Device Name |
Exablate Model 4000 Type-1 System
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| Clinical Trial Number(s) |
NCT04728295
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| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
Study Design:
An international prospective, multi-center, assessor-blinded, two-stage randomized controlled trial evaluating successive Exablate treatment (first and second side) versus BMT.
Primary Objective:
To compare the effect of the MDS-UPDRS Part III Upper Lower Extremity (ULE) score in the OFF-medication state for the treated side at Month 3 versus respective baseline for each Exablate PTT Intervention:
(1) Active Group 1 (1st Side Exablate) vs. Control Group 1 (BMT)
(2) Active Group 2 (2nd Side Exablate) vs. Control Group 2 (1st Side + BMT).
These combined comparisons are intended to demonstrate the overall therapeutic impact of Exablate PTT interventions.
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| Study Population |
Patients diagnosed with idiopathic Parkinson’s disease experiencing bilateral motor symptoms and motor complications not adequately controlled by medication therapy.
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| Sample Size |
Minimum 90 and up to 120 subjects treated (1st side) to get to a minimum of 60 subjects in the Exablate Treated Arm at Month 3 post 2nd side (T2-M3) at up to 25 sites worldwide.
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| Key Study Endpoints |
Effectiveness Endpoints
Co-Primary Endpoints
Formal analyses of Primary Endpoint 1 and Primary Endpoint 2 will be conducted at different timepoints as detailed below and will include the following:
Primary Endpoint 1: the between-group difference (Active Group 1 vs. Control Group 1) in the treatment effect (point change) in the MDS-UPRDS Part III ULE score in the OFF-medication state from BL1 to T1-M3.
This assessment will be performed by a Movement Disorders neurologist blinded to patient study group allocation.
Primary Endpoint 2: the between-group difference (Active Group 2 vs. Control Group 2) in the treatment effect (point change) in the MDS-UPRDS Part III ULE score in the OFF-medication state from BL-2 to T2-M3.
This assessment will be performed by a Movement Disorders neurologist blinded to patient study
group allocation.
Secondary Effectiveness Endpoints
Formal analyses of Secondary 1 (1st side treatment) and Secondary 2 (2nd side treatment) Endpoints will be conducted at different timepoints as detailed below and will assess the following:
• MDS-UPDRS III Total score in the OFF-medication state
• MDS-UPDRS Part III OFF ULE score & % change (on the first side, second side and both sides combined)
• MDS-UPDRS Part III ON Total score & % change
• MDS-UPDRS Part IV Total score & % change
• Number of hours per day in ON time without troublesome dyskinesia- as measured by patient diaries
• Number of hours per day in the OFF time as measured by patient diaries
• Number of hours per day with troublesome dyskinesia
• Quality of Life as measured by PDQ-39
• Daily Medication (L-DOPA equivalents)
Secondary 1: 1st side Treatment Endpoints
• Between-group comparison (Active Group 1 vs Control Group 1) of the treatment effect at Month 3 following Treatment 1 (T1-M3) compared to baseline (BL-1) for all assessments
• Within-group comparison (Active Group 1) of the treatment effect at all study visits (Month 1, 3 and 6) following Treatment 1 compared to baseline (BL-1) for all assessments
Secondary 2: 2nd side Treatment Endpoints
6. Between-group comparison (Active Group 2 vs Control Group 2) of the treatment effect at Month 3 post Treatment 2 (T2-M3) compared to re-baseline (BL-2) for all assessments
7. Within-group comparison (Active Group 2) of the treatment effect at all study visits (Month
1, 3, 6 and 12) following Treatment 2 compared to re-baseline (BL-2) for all assessments
Safety Analysis
Exablate intervention treatments will be summarized alongside those from the control group receiving relevant best medical therapy. The incidence and severity of adverse events (AEs) will be summarized descriptively for each treatment group throughout the comparative part of the study.
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| Follow-up Visits and Length of Follow-up |
Active Group 1: Month 1 -/+ 7 days, Month 3 -/+ 14 days, and Month 6 -/+ 21 day; after the Month 6 visit, subjects will be randomized again into either Active Group 2 or Control Group 2 and will follow that schedule of events.
Active Group 2: Month 1 -/+ 7 days, Month 3 -/+ 14 days, and Month 6 -/+ 21 day and Month 12 -/+ 60 day; at the end of their Month 12 visit subjects will be considered as having completed the study and be exited.
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