Nilotinib in Parkinson's Disease

A Randomized, Double-Blind, Placebo-Controlled, Phase IIa, Parallel Group, Two Cohort Study to Define the Safety, Tolerability, Clinical and Exploratory Biological Activity of the Chronic Administration of Nilotinib in Participants With Parkinson's Disease

Recruitment Information:

Seeking volunteers with following diagnosis: PD Study Type: Interventional
Eligible Ages: 40 - 79 Status: Active, not recruiting
Time Since Diagnosis: 5 - 60 years Study Focus: Neuroprotection

Study Purpose:

This study will assess the safety and tolerability of daily oral administration of nilotinib (150-300mg once daily) in Parkinson's Disease.

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More Details

The purpose of this study is to determine if nilotinib is safe, if it can be tolerated by patients with Parkinson's disease (PD) and to learn if nilotinib has the possibility of effectively treating PD symptoms. Nilotinib has been approved by the Food and Drug Administration (FDA) to treat certain types of cancer (leukemia) but is considered investigational in this study because it has not been approved for treating PD. Twenty-five sites will enroll 75 participants in the study. Participants with moderate to advanced PD symptoms will be enrolled, randomly assigned to take nilotinib (150 mg or 300mg) or placebo, and will complete 13 in-person study visits over 8.5 months. Study visits will include clinical assessment of motor, neuropsychiatric and cognitive testing as well as collection of blood and cerebral spinal fluid, collected by lumbar puncture. This study will also evaluate if nilotinib can help improve motor symptoms associated with PD. All participants will have an assessment of the motor exam (Part III) in a practically defined OFF state (12 hours post dose) and ON state (at least one-hour post dose). Based on the results of the first study, this trial may lead to a second study in individuals with early-stage PD.

Phase: Phase 2 Lead Sponsor: Northwestern University
Trial ID: 004999 Sponsor Type: Other
Primary Country: United States Additional Collaborators or Sponsors: University of Rochester, University of Iowa, Michael J. Fox Foundation for Parkinson's Research
Estimated Enrollment: 0 Study Start Date: October 2017
Estimated Study Completion Date: October 2020 Source:
Study Website:

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