Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease (PD Nilotinib)
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|ClinicalTrials.gov Identifier: NCT02954978|
Recruitment Status : Unknown
Verified March 2019 by Fernando Pagan MD, Georgetown University.
Recruitment status was: Active, not recruiting
First Posted : November 4, 2016
Last Update Posted : March 14, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Parkinsons Disease With Dementia||Drug: Placebo Oral Capsule Drug: Nilotinib 150mg oral capsule [Tasigna] Drug: Nilotinib 300mg oral capsule [Tasigna]||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Low Doses of Nilotinib Treatment on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||July 2020|
Placebo Comparator: Placebo
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.
Drug: Placebo Oral Capsule
25 patients in group 1 will receive Placebo ("sugar pill") one (1) capsule once daily (taken without a meal) for 12 months and 3 months follow up.
Other Name: Placebo
Active Comparator: Nilotinib 150mg
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.
Drug: Nilotinib 150mg oral capsule [Tasigna]
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.
Other Name: Nilotinib low dose
Active Comparator: Nilotinib 300mg
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.
Drug: Nilotinib 300mg oral capsule [Tasigna]
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.
Other Name: Nilotinib high dose
- Safety will be measured by number of participants experiencing the occurrence of adverse events and/or abnormal laboratory values [ Time Frame: 12 months ]Safety will be measured by assessing number of participants with abnormal laboratory values, as well as adverse events (AEs) and serious adverse events (SAEs) deemed to be possibly, probably, or definitely related to the study drug.
- Effects of nilotinib treatment on levels of homovanillic acid in cerebrospinal fluid [ Time Frame: 12 months ]The investigators will determine the effects of nilotinib on cerebrospinal fluid levels of homovanillic acid between baseline and 12 months.
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|Ages Eligible for Study:||40 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Written informed consent
- Capable of providing informed consent and complying with study procedures. Subjects who are unable to provide consent may use a Legally Authorized Representative (LAR).
- Patients between the age of 40-90 years, medically stable
- Diagnosis of PD according to the UK Brain Bank Diagnostic Criteria
- PD subjects with MoCA ≥ 22
- 2.5 ≥Hoehn and Yahr stage ≤3
- No mono-amine oxidase (MAO)-B inhibitors (Selegeline or rasagiline) are allowed at least 6 weeks before enrollment
- Must be medically stable on 800mg Levodopa daily for at least 4 weeks
- QTc interval 350-460 ms, inclusive
- Participants must be willing to undergo LP at baseline and 12 months after treatment
- Patients with hypokalemia, hypomagnesaemia, or long QT syndrome- QTc≥461 ms
- Concomitant drugs known to prolong the QTc interval and history of any cardiovascular disease, including myocardial infraction or cardiac failure, angina, arrhythmia
History or presence of cardiac conditions including:
- Cardiovascular or cerebrovascular event (e.g. myocardial infarction, unstable angina, or stroke)
- Congestive heart failure
- First, second- or third-degree atrioventricular block, sick sinus syndrome, or other serious cardiac rhythm disturbances
- Any history of Torsade de Pointes
Treatment with any of the following drugs at the time of screening or the preceding 30 days, and/or planned use over the course of the trial:
- Treatment with Class IA or III antiarrhythmic drugs (e.g. quinidine)
- Treatment with QT prolonging drugs (www.crediblemeds.org)- excluding Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g. Citalopram, Paxil, Zoloft, Cymbalta, Sertraline, etc...)
- Strong CYP3A4 inhibitors (including grapefruit juice). The concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) must be avoided. Grapefruit products may also increase serum concentrations of Nilotinib. Should treatment with any of these agents be required, therapy with Nilotinib should be interrupted.
- Anticoagulants, including Coumadin (warfarin), heparin, enoxaparin, daltiparin, xarelto, etc.
- St. John's Wort and the concomitant use of strong other CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) must be avoided since these agents may reduce the concentration of Nilotinib.
- Abnormal liver function defined as AST and/or ALT > 100% the upper limit of the normal
- Renal insufficiency as defined by a serum creatinine > 1.5 times the upper limit of normal
- History of HIV, clinically significant chronic hepatitis, or other active infection
- Females must not be lactating, pregnant or with possible pregnancy
- Medical history of liver or pancreatic disease
- Clinical signs indicating syndromes other than idiopathic PD, including corticobasal degeneration, supranuclear gaze palsy, multiple system atrophy, chronic traumatic encephalopathy, signs of frontal dementia, history of stroke, head injury or encephalitis, cerebellar signs, early severe autonomic involvement, Babinski sign
- Current evidence or history in past two years of epilepsy, focal brain lesion, head injury with loss of consciousness or DSM-IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
- Evidence of any significant clinical disorder or laboratory finding that renders the participant unsuitable for receiving an investigational drug including clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, metabolic, renal or other systemic disease or laboratory abnormality
- Active neoplastic disease, history of cancer five years prior to screening, including breast cancer (history of skin melanoma or stable prostate cancer are not exclusionary)
- Contraindications to LP: prior lumbosacral spine surgery, severe degenerative joint disease or deformity of the spine, platelets < 100,000, use of Coumadin/warfarin, or history of a bleeding disorder
- Must not be on any immunosuppressant medications (e.g. IVig)
- Must not be enrolled as an active participant in another clinical study
- Diagnosis of DLB
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954978
|United States, District of Columbia|
|MedStar Georgetown University Hospital|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Fernando L Pagan, MD||Georgetown University|
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Fernando Pagan MD, Associate Professor, Department of Neurology Co-Director, Movement Disorders Program Director, NPF Center of Excellence Associate Professor, SOM Clinical Track, Georgetown University|
|Other Study ID Numbers:||
|First Posted:||November 4, 2016 Key Record Dates|
|Last Update Posted:||March 14, 2019|
|Last Verified:||March 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
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