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ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03319485
Recruitment Status : Active, not recruiting
First Posted : October 24, 2017
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
InSightec

Tracking Information
First Submitted Date  ICMJE October 19, 2017
First Posted Date  ICMJE October 24, 2017
Last Update Posted Date November 9, 2020
Actual Study Start Date  ICMJE February 9, 2018
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
Responder Analysis [ Time Frame: Change in UDysRS and MDS-UPDRS Part III Motor Exam score from before treatment to 3 months following treatment ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 23, 2017)
Unified Dyskinesia Rating Scale (UDysRS) Score [ Time Frame: Change in UDysRS score from before treatment to 3 months following treatment ]
To compare the change in total UDysRS score from Baseline to Month 3
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2017)
Severity of Device and Procedure related complications [ Time Frame: At the time of ExAblate Pallidotomy procedure ]
To evaluate of the incidence and severity of device- and procedure-related
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease
Official Title  ICMJE A Pivotal Clinical Trial of the Management of the Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Idiopathic Parkinson's Disease With Unilateral Lesioning of the Globus Pallidum Using the ExAblate Neuro System
Brief 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.
Detailed Description The goal of this prospective, two-arm, sham-controlled, randomized, multi-center pivotal study is to 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Device: ExAblate Pallidotomy
    ExAblate Pallidotomy for Parkinson's Disease
    Other Names:
    • MRgFUS
    • Pallidotomy
  • Device: Sham ExAblate Pallidotomy
    ExAblate MRgFUS Sham Procedure
Study Arms  ICMJE
  • Experimental: ExAblate Pallidotomy
    ExAblate treatment for Advanced Idiopathic Parkinson's Disease
    Intervention: Device: ExAblate Pallidotomy
  • Sham Comparator: Sham ExAblate Pallidotomy
    Sham (fake) treatment
    Intervention: Device: Sham ExAblate Pallidotomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 21, 2020)
92
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2017)
116
Estimated Study Completion Date  ICMJE January 31, 2025
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men and women, age 30 years and older.
  2. Subjects who are able and willing to give informed consent and able to attend all study visits through 12 Months.
  3. Subjects with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site.
  4. Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor subscale in the ON vs OFF medication state.
  5. MDS-UPDRS score of ≥ 20 in the meds OFF condition OR Motor complications of PD on optimum medical treatment .
  6. Subjects should be on a stable dose of all PD medications for 30 days prior to study entry as determined by medical records.
  7. Subject is able to communicate sensations during the ExAblate procedure.
  8. Subjects on stable antidepressant medications for at least 3 months

Exclusion Criteria:

  1. Hoehn and Yahr stage in the ON medication state of 3 or greater.
  2. Presence of other central neurodegenerative disease suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia with Lewy bodies, and Alzheimer's disease.
  3. Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
  4. Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia.
  5. Presence of significant cognitive impairment using MMSE ≤ 24.
  6. Unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation.
  7. Subjects with an active alcohol or drug dependency or history of drug/alcohol abuse within the past year
  8. Subjects with unstable cardiac status
  9. Severe hypertension (diastolic BP > 100 on medication).
  10. Current medical condition resulting in abnormal bleeding and/or coagulopathy.
  11. Receiving anticoagulant (e.g., warfarin) or antiplatelet (e.g., aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g., Avastin) within one month of focused ultrasound procedure.
  12. Subjects with risk factors for intraoperative or postoperative bleeding as indicated by: platelet count less than 100,000 per cubic millimeter; a documented clinical coagulopathy; or INR coagulation studies exceeding the institution's laboratory standard
  13. Patient with kidney disease or on dialysis.
  14. Subjects with standard contraindications for MR imaging
  15. Significant claustrophobia that cannot be managed with mild medication.
  16. Subjects who weigh more than the upper weight limit of the MR scanner table and who cannot fit into the MR scanner.
  17. Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment.
  18. History of intracranial hemorrhage, multiple strokes, or a stroke within past 6 months.
  19. Subjects with a history of seizures within the past year.
  20. Subjects with brain tumors.
  21. Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment.
  22. Are participating or have participated in another clinical trial in the last 30 days.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Israel,   Italy,   Korea, Republic of,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03319485
Other Study ID Numbers  ICMJE PD006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InSightec
Study Sponsor  ICMJE InSightec
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account InSightec
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP