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Tyrosine Kinase Inhibitor

Nilotinib 150mg for Parkinson's Disease (PD Nilotinib Trial)

Phase 2
Waitlist Available
Led By Fernando L Pagan, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

PD Nilotinib Trial Summary

Parkinson's disease (PD) is the second most common neurodegenerative disorder causing motor and non-motor symptoms. PD is characterized by death of dopaminergic (DA) neurons in the substantia nigra (SN) pars compacta and formation of inclusions known as Lewy bodies (LBs) that primarily contain aggregated alpha-Synuclein. Nilotinib (Tasigna®, AMN107, Novartis, Switzerland) is approved by U.S. Food and Drug Administration (FDA) and is well tolerated for CML treatment at oral doses of 600-800mg daily. Nilotinib penetrates the brain and promotes autophagic degradation of alpha-Synuclein and p-Tau, leading to survival of DA neurons and improvement of motor function in PD models. For these studies, Nilotinib (1-10mg/kg daily) was used at significantly less than the clinically approved dose (up to 1200mg daily) in CML.

Eligible Conditions
  • Parkinson's Disease

PD Nilotinib Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety will be measured by number of participants experiencing the occurrence of adverse events and/or abnormal laboratory values
Secondary outcome measures
Effects of nilotinib treatment on levels of homovanillic acid in cerebrospinal fluid

PD Nilotinib Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Nilotinib 150mgActive Control1 Intervention
Out of seventy five (75) participants that will be recruited and randomly assigned 1:1:1 to the three (3) groups (arms), 25 patients in group 2 will receive 150mg Nilotinib one (1) capsule once daily (taken without a meal) for 12 months and 3 months follow up.
Group II: Nilotinib 300mgActive Control1 Intervention
Out of seventy five (75) participants that will be recruited and randomly assigned 1:1:1 to the three (3) groups (arms), 25 patients in group 3 will receive 300mg Nilotinib one (1) capsule once daily (taken without a meal) for 12 months and 3 months follow up.
Group III: PlaceboPlacebo Group1 Intervention
Out of seventy five (75) participants that will be recruited and randomly assigned 1:1:1 to the three (3) groups (arms), 25 patients in group 1 will receive the placebo ("sugar pill") one (1) capsule by mouth once daily (taken without a meal) for 12 months and 3 months follow up.

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,427 Total Patients Enrolled
Fernando L Pagan, MDPrincipal InvestigatorGeorgetown University
4 Previous Clinical Trials
165 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease
Fernando Pagan MD 2017. "Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02954978.
All > Parkinson
~9 spots leftby Apr 2025
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