CompletedNot Applicable

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

Canada4 participantsStarted 2020-07-16

Plain-language 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).

Who can participate

Age range35 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Contrast enhancement on MR imaging

Timeframe: Immediately after MRgFUS BBBD procedure

Trial details

NCT IDNCT04370665

SponsorInSightec

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-31

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