What is the NILO-PD study?
The NILO-PD study will investigate the safety and tolerability of nilotinib. The Parkinson Study Group (PSG) is conducting this clinical trial in approximately 25 research institutions across the United States. We will enroll 75 participants.
This study is funded by The Michael J. Fox Foundation for Parkinson’s Research.
What is the Inclusion/Exclusion Criteria for the NILO-PD Study?Participants must meet certain criteria. Some are:
— You must be between the ages of 40 and 79
— You must have been diagnosed with Parkinson’s disease (PD) for more than 5 years
— You need to be on a stable regimen of PD medications that includes levodopa for at least 30 days prior to screening visit
What will I have to do throughout the study?
— Nilotinib is a capsule that will be taken orally on a daily basis.
— The study will include 11 in person study visits.
— Clinical assessments and questionnaires will be completed
— Several blood samples will be collected throughout the study
— Certain visits will require a Lumbar Puncture (LP)
Will everyone receive nilotinib?
It is important that you know this is a placebo controlled study and one-third of the participants will receive a placebo. While the remaining two thirds of participants will receive nilotinib. A placebo is an inactive pill and is often used in research studies to determine whether or not the active study drug is effective.
How long will I be in the study?
For Cohort 1, your involvement with the study will last approximately 8.5 — 9months.
For Cohort 2, your involvement with the study will last approximately 15 months.
What are the benefits of participating in the NILO-PD Study?
Currently, the benefits to you are unknown, but nilotinib may help to normalize the function of the pathways in the brain and reduce alpha-synuclein from collecting, potentially helping to relieve PD symptoms. While there may be no direct benefit to you from participating in the NILO-PD study, you may be contributing to the growing knowledge about PD.
What are the Risks?
Nilotinib can cause an irregular heartbeat called QT prolongation which can lead to sudden death but your doctor will monitor you heart rate closely. Fever, nausea, cough, headache and tiredness are a few other side effects. Please ask the study doctor about other possible side effects.
What is a Lumbar Puncture?
An outpatient procedure where a small needle is inserted between the vertebrae of the lower back at a level below the spinal cord to obtain a small amount of spinal fluid. You may feel some discomfort. First, during the administration of an anesthetic, you may feel a few seconds of stinging or burning when it is injected. Second, you will feel a pressure sensation when the needle is inserted, and there is usually some brief pain when the needle goes through the tissue surrounding the spinal cord. Overall, discomfort throughout the entire procedure is minimal to moderate.
Please refer to the Lumbar Puncture FAQ sheet under the links tab on this website.