Status:
UNKNOWN
Blood-Brain-Barrier Disruption With Cerezyme in Patient's With Parkinson's Disease
Lead Sponsor:
InSightec
Conditions:
Parkinson Disease
Eligibility:
All Genders
35-75 years
Phase:
NA
Brief 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 t...
Eligibility Criteria
Inclusion
- Men or women between age 35 and 75 years, inclusive.
- Able and willing to give informed consent.
- Diagnosis of Parkinson's Disease.
- At least 2 years from initial diagnosis
- On stable regiment of PD medications for at least 90 days prior to the study
- Able to communicate during the Exablate MRgFUS procedure.
- Able to attend all study visits.
Exclusion
- Previous neurosurgical procedure for PD
- Cerezyme hypersensitivity
- Patients who had recent intracranial hemorrhage or stroke
- 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.
- 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).
- Patients with a history of a bleeding disorder, blood clotting, coagulopathy or with a history of spontaneous tumor hemorrhage.
- Patients receiving bevacizumab (Avastin) therapy.
- Currently participating in another clinical therapeutic trial
- Documented myocardial infarction within six months of enrollment.
- Unstable angina on medication.
- Congestive heart failure.
- Unstable cardiac arrhythmia.
- Cardiac pacemaker.
- Severe hypertension (diastolic BP \> 100 on medication).
- Documented cerebral infarction within the past 12 months or TIA in the past 1 month.
- Insulin-dependent diabetes mellitus that is not well-controlled or that in the Investigator's opinion precludes participation in the study.
- Known sensitivity to gadolinium
- Known sensitivity to DEFINITY ultrasound contrast agent or perflutren.
- Contraindications to MRI such as non-MRI-compatible implanted devices.
- Large subjects not fitting comfortably into the MRI scanner.
- Difficulty lying supine and still for up to 4 hours in the MRI unit or claustrophobia.
- Untreated, uncontrolled sleep apnea.
- Positive pregnancy test (for pre-menopausal women).
- Known life-threatening systemic disease.
- Severely impaired renal function and/or on dialysis.
- Right to left or bi-directional cardiac shunt.
- Subjects with evidence of cranial or systemic infection.
- Subjects with uncontrolled chronic pulmonary disorders.
- Subjects with a history of severe asthma, hay fever, or multiple allergies that is not well-controlled (e.g. with anaphylaxis).
- Subjects with a family or personal history of cardiac arrhythmia.
- Severe liver injury.
Key Trial Info
Start Date :
July 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04370665
Start Date
July 16 2020
End Date
December 1 2022
Last Update
August 2 2022
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5