A Phase II Double Blind, Placebo-Controlled, Parallel Group, Two-Cohort study of nilotinib to determine the safety and tolerability in participants with Parkinson’s Disease (PD).

As you may know, nilotinib is a marketed drug and approved by the Food and Drug Administration (FDA) for the treatment of certain types of leukemia. The drug is not currently indicated for treatment in Parkinson’s disease but there is preclinical data and a small open label clinical trial suggesting nilotinib may hold promise as a treatment for PD.

Nilotinib has a number of safety concerns specifically related to potential risk of cardiac and hematologic toxicity. The current study protocol was designed with tight adherence to the safety monitoring recommendations as described in the package insert. Please use the following link to view the nilotinib package insert.

https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/tasigna.pdf

In addition, below is a summary of dosing instructions for commonly prescribed medications:
1) H2 blockers are allowed. However, these medicines should be taken 10 hours before or 2 hours after taking the study drug.
2) Antacid that contains aluminum hydroxide, magnesium hydroxide or simethicone are allowed. However, these medications should be taken about 2 hours before or about 2 hours after taking the study drug.
3) Use of grapefruit juice and grapefruit products will be prohibited (due to inhibition of CYP3A4)

The following medications are restricted or not allowed during subject participation in the study

If any disallowed medications are required and cannot be discontinued, study drug should be stopped and the subject should continue to be followed in the study off of study drug. Please notify the study team immediately regarding initiation of disallowed medications.

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EXCLUSIONARY AND PRECAUTIONARY MEDICATIONS
NOTE: This list is not exhaustive but is designed to give examples of more commonly used drug classes.

Table 1. Exclusionary Medications: Known risk to prolong the QT interval