Loading clinical trials...

Blood-Brain-Barrier Disruption With Cerezyme in Patient's With Parkinson's Disease | Clinical Trials | Clareo Health

COMPLETEDNA

Blood-Brain-Barrier Disruption With Cerezyme in Patient's With Parkinson's Disease

A Pilot Study for Brain Delivery of Cerezyme® in Patients With Parkinson's Disease Using MR-guided Focused Ultrasound Induced Opening of the Blood-brain Barrier

NCT04370665•InSightec

View on ClinicalTrials.gov

Summary

This clinical trial focus on the delivery of Cerezyme® in Parkinson's Disease (PD) patients using MR-guided focused ultrasound (MRgFUS) induced opening of the blood-brain barrier (BBB).

Detailed Description

Leveraging the preclinical evidence and clinical experience with MRgFUS BBB opening in human subjects, the investigators propose a phase I open-label study to determine the safety and feasibility of three biweekly delivery of Cerezyme® (an analogue of the human enzyme beta-glucocerebrosidase) via MRgFUS induced BBB opening to unilateral putamen in PD. The putamen contains terminals of dopaminergic neurons from the substantia nigra, and is a critically affected brain region in PD. The primary objective is to determine the feasibility of repeated MRgFUS BBB opening for Cerezyme delivery in unilateral putamen. The secondary objective is to describe the safety and tolerability of the procedure. Another objective is to measure changes in PD relevant clinical scores and Cerezyme relevant biomarkers in the study.

Eligibility

Age

35 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men or women between age 35 and 75 years, inclusive.
•2. Able and willing to give informed consent.
•3. Diagnosis of Parkinson's Disease.
•4. At least 2 years from initial diagnosis
•5. On stable regiment of PD medications for at least 90 days prior to the study
•6. Able to communicate during the Exablate MRgFUS procedure.
•7. Able to attend all study visits.

Exclusion Criteria

•1. Previous neurosurgical procedure for PD
•2. Cerezyme hypersensitivity
•3. Patients who had recent intracranial hemorrhage or stroke
•4. Skull covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp. Patients who have clips or other metallic implanted objects in the skull or the brain.
•5. Patients who are on blood thinners within washout period prior to treatment (i.e., antiplatelet or vitamin K inhibitor anticoagulants within 7 days, non-vitamin K inhibitor anticoagulants within 72 hours, or heparin-derived compounds within 48 hours of treatment).
•6. Patients with a history of a bleeding disorder, blood clotting, coagulopathy or with a history of spontaneous tumor hemorrhage.
•7. Patients receiving bevacizumab (Avastin) therapy.
•8. Currently participating in another clinical therapeutic trial
•9. Documented myocardial infarction within six months of enrollment.
•10. Unstable angina on medication.
+21 more criteria

Locations (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Key Dates

Start Date

July 16, 2020

Primary Completion Date

December 31, 2021

Completion Date

February 25, 2022

Last Updated

March 20, 2026

Enrollment

ACTUAL participants

Conditions

Parkinson Disease

Interventions

Exablate BBBD with Cerezyme

DEVICE

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

View study

RECRUITINGNA

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Blood-Brain-Barrier Disruption With Cerezyme in Patient's With Parkinson's Disease

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations