Trial Outcomes & Findings for Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease (NCT NCT02954978)
NCT ID: NCT02954978
Last Updated: 2026-06-12
Results Overview
Safety will be measured by assessing number of participants with adverse events (AEs) and serious adverse events (SAEs) deemed to be possibly, probably, or definitely related to the study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
12 months
Results posted on
2026-06-12
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
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.
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
22
|
23
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=25 Participants
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.
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.
|
Nilotinib 150mg
n=25 Participants
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.
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.
|
Nilotinib 300mg
n=25 Participants
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.
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.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
21 Participants
n=265 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=9 Participants
|
16 Participants
n=27 Participants
|
20 Participants
n=267 Participants
|
54 Participants
n=265 Participants
|
|
Age, Continuous
|
68.64 years
STANDARD_DEVIATION 7.56 • n=9 Participants
|
66.56 years
STANDARD_DEVIATION 9.89 • n=27 Participants
|
70 years
STANDARD_DEVIATION 7.15 • n=267 Participants
|
68.4 years
STANDARD_DEVIATION 8.3 • n=265 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
20 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
20 Participants
n=267 Participants
|
55 Participants
n=265 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=9 Participants
|
25 Participants
n=27 Participants
|
25 Participants
n=267 Participants
|
74 Participants
n=265 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=9 Participants
|
25 participants
n=27 Participants
|
25 participants
n=267 Participants
|
75 participants
n=265 Participants
|
PRIMARY outcome
Timeframe: 12 monthsSafety will be measured by assessing number of participants with adverse events (AEs) and serious adverse events (SAEs) deemed to be possibly, probably, or definitely related to the study drug.
Outcome measures
| Measure |
Placebo
n=25 Participants
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.
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.
|
Nilotinib 150mg
n=25 Participants
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.
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.
|
Nilotinib 300mg
n=25 Participants
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.
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.
|
|---|---|---|---|
|
Safety Will be Measured by Number of Participants Experiencing the Occurrence of Adverse Events
Adverse Events
|
65 events
|
71 events
|
57 events
|
|
Safety Will be Measured by Number of Participants Experiencing the Occurrence of Adverse Events
Severe Adverse Events
|
4 events
|
6 events
|
12 events
|
SECONDARY outcome
Timeframe: 12 monthsQuantification of homovanillic acid (HVA) and 3,4,-dihydroxyphenylacetic acid (DOPAC) in human CSF by ultra-high performance liquid chromatography with tandem mass spectrometry in cerebrospinal fluid at 12 months.
Outcome measures
| Measure |
Placebo
n=21 Participants
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.
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.
|
Nilotinib 150mg
n=22 Participants
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.
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.
|
Nilotinib 300mg
n=20 Participants
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.
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.
|
|---|---|---|---|
|
Biomarker Analysis
CSF Homovanillic Acid (nM)
|
393 nM
Standard Deviation 241.6
|
552.9 nM
Standard Deviation 345.6
|
479.7 nM
Standard Deviation 444.6
|
|
Biomarker Analysis
CSF DOPAC (nM)
|
5.73 nM
Standard Deviation 3.39
|
10.6 nM
Standard Deviation 8.559
|
13.25 nM
Standard Deviation 13.03
|
SECONDARY outcome
Timeframe: 12 monthsQuantification of alpha-synuclein (a-syn), oligomeric a-syn, phospho-Tau (181) (p-Tau(181)), and Total Tau (tTau) in human CSF by Enzyme-Linked Immunosorbent Assay (ELISA) at 12 months.
Outcome measures
| Measure |
Placebo
n=21 Participants
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.
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.
|
Nilotinib 150mg
n=22 Participants
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.
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.
|
Nilotinib 300mg
n=20 Participants
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.
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.
|
|---|---|---|---|
|
Biomarker Analysis (Amyloid Markers) in Cerebral Spinal Fluid (CSF)
CSF Total alpha-synuclein
|
752.2 pg/ml
Standard Deviation 340.1
|
833.9 pg/ml
Standard Deviation 746.4
|
1144 pg/ml
Standard Deviation 1549
|
|
Biomarker Analysis (Amyloid Markers) in Cerebral Spinal Fluid (CSF)
CSF Oligomeric alpha-synuclein
|
0.2141 pg/ml
Standard Deviation 0.07022
|
0.1699 pg/ml
Standard Deviation 0.06797
|
0.1972 pg/ml
Standard Deviation 0.05595
|
|
Biomarker Analysis (Amyloid Markers) in Cerebral Spinal Fluid (CSF)
CSF Phospho-Tau(181)
|
32.09 pg/ml
Standard Deviation 16.17
|
22.05 pg/ml
Standard Deviation 10.36
|
20.04 pg/ml
Standard Deviation 8.376
|
|
Biomarker Analysis (Amyloid Markers) in Cerebral Spinal Fluid (CSF)
CSF Total Tau
|
198.2 pg/ml
Standard Deviation 83.92
|
176.9 pg/ml
Standard Deviation 100.2
|
169 pg/ml
Standard Deviation 103.2
|
SECONDARY outcome
Timeframe: 12 monthsRatio of oligomeric a-syn to alpha-synuclein (a-syn), and phospho-Tau (181) (p-Tau(181)) to Total Tau (tTau) in human CSF at 12 months.
Outcome measures
| Measure |
Placebo
n=21 Participants
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.
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.
|
Nilotinib 150mg
n=22 Participants
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.
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.
|
Nilotinib 300mg
n=20 Participants
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.
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.
|
|---|---|---|---|
|
Biomarker Analysis (Ratio of Amyloid Markers) in Cerebral Spinal Fluid (CSF)
CSF Ratio of Oligomeric/Total al[pha-synuclein
|
0.0003895 ratio
Standard Deviation 0.0001899
|
0.0002751 ratio
Standard Deviation 0.0001964
|
0.0004030 ratio
Standard Deviation 0.0003310
|
|
Biomarker Analysis (Ratio of Amyloid Markers) in Cerebral Spinal Fluid (CSF)
CSF Phospho-Tau(181)/Total Tau
|
0.1678 ratio
Standard Deviation 0.05524
|
0.1340 ratio
Standard Deviation 0.06035
|
0.1336 ratio
Standard Deviation 0.05333
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Nilotinib 150mg
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Nilotinib 300mg
Serious events: 9 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=25 participants at risk
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.
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.
|
Nilotinib 150mg
n=25 participants at risk
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.
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.
|
Nilotinib 300mg
n=25 participants at risk
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.
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.
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Musculoskeletal and connective tissue disorders
Discitis Osteomyelitis
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Cardiac disorders
Prolonged QTc due to Takotsubocardiomyopathy
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
General disorders
Falls
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Musculoskeletal and connective tissue disorders
Prosthetic instability repair
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Cardiac disorders
Angina type symptoms and stent replacement
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Cardiac disorders
Atrial flutter detected on EKG followed by 2 stent replacements
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Gastrointestinal disorders
Death due to metastatic pancreatic cancer
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
General disorders
Severe cramp pain and falls
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Nervous system disorders
Orhtostatic hypotension
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Psychiatric disorders
Psychosis and attempted suicide
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Cardiac disorders
Stroke
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
Other adverse events
| Measure |
Placebo
n=25 participants at risk
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.
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.
|
Nilotinib 150mg
n=25 participants at risk
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.
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.
|
Nilotinib 300mg
n=25 participants at risk
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.
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.
|
|---|---|---|---|
|
General disorders
Sinnusitis
|
8.0%
2/25 • Number of events 2 • Adverse events were collected for 15 months per patient.
|
8.0%
2/25 • Number of events 2 • Adverse events were collected for 15 months per patient.
|
12.0%
3/25 • Number of events 3 • Adverse events were collected for 15 months per patient.
|
|
General disorders
Tinnitus
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Hepatobiliary disorders
Elevated Lipase/Amylase Levels
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
8.0%
2/25 • Number of events 2 • Adverse events were collected for 15 months per patient.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
40.0%
10/25 • Number of events 10 • Adverse events were collected for 15 months per patient.
|
64.0%
16/25 • Number of events 16 • Adverse events were collected for 15 months per patient.
|
36.0%
9/25 • Number of events 9 • Adverse events were collected for 15 months per patient.
|
|
Nervous system disorders
Vertigo
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Nervous system disorders
Confusion
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Nervous system disorders
Post-LP Headache
|
20.0%
5/25 • Number of events 5 • Adverse events were collected for 15 months per patient.
|
20.0%
5/25 • Number of events 5 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Psychiatric disorders
Hallucinations
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Renal and urinary disorders
Hematuria
|
8.0%
2/25 • Number of events 2 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
8.0%
2/25 • Number of events 2 • Adverse events were collected for 15 months per patient.
|
|
Renal and urinary disorders
Glomerular Filtration
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Renal and urinary disorders
Prostate Infection
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
2/25 • Number of events 2 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
8.0%
2/25 • Number of events 2 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
20.0%
5/25 • Number of events 5 • Adverse events were collected for 15 months per patient.
|
24.0%
6/25 • Number of events 6 • Adverse events were collected for 15 months per patient.
|
20.0%
5/25 • Number of events 5 • Adverse events were collected for 15 months per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
8.0%
2/25 • Number of events 2 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
8.0%
2/25 • Number of events 2 • Adverse events were collected for 15 months per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Skin and subcutaneous tissue disorders
Itching and Rash
|
12.0%
3/25 • Number of events 3 • Adverse events were collected for 15 months per patient.
|
12.0%
3/25 • Number of events 3 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Skin and subcutaneous tissue disorders
Melanoma Excision
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Skin and subcutaneous tissue disorders
Skin Lesions
|
12.0%
3/25 • Number of events 3 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
12.0%
3/25 • Number of events 3 • Adverse events were collected for 15 months per patient.
|
|
Skin and subcutaneous tissue disorders
Edema
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Skin and subcutaneous tissue disorders
Cyst
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Skin and subcutaneous tissue disorders
Wart Lesion
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Skin and subcutaneous tissue disorders
Skin Biopsies
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
12.0%
3/25 • Number of events 3 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Skin and subcutaneous tissue disorders
Testicular Nodule
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Skin and subcutaneous tissue disorders
Nonhealing Wound
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Skin and subcutaneous tissue disorders
Tick Bite
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Gastrointestinal disorders
Stomach Virus
|
20.0%
5/25 • Number of events 5 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
20.0%
5/25 • Number of events 5 • Adverse events were collected for 15 months per patient.
|
|
Cardiac disorders
Bigeminy
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Cardiac disorders
Pacemaker
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Cardiac disorders
Whooshing in Chest
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Eye disorders
Cataract
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Eye disorders
Blurry Vision
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
General disorders
Falls
|
36.0%
9/25 • Number of events 9 • Adverse events were collected for 15 months per patient.
|
52.0%
13/25 • Number of events 13 • Adverse events were collected for 15 months per patient.
|
52.0%
13/25 • Number of events 13 • Adverse events were collected for 15 months per patient.
|
|
General disorders
Flu
|
8.0%
2/25 • Number of events 2 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
12.0%
3/25 • Number of events 3 • Adverse events were collected for 15 months per patient.
|
|
General disorders
Hematologic
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for 15 months per patient.
|
|
Eye disorders
Stye
|
8.0%
2/25 • Number of events 2 • Adverse events were collected for 15 months per patient.
|
8.0%
2/25 • Number of events 2 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Eye disorders
Eye Laceration
|
8.0%
2/25 • Number of events 2 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
|
Cardiac disorders
QTc interval prolongation
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
8.0%
2/25 • Number of events 2 • Adverse events were collected for 15 months per patient.
|
0.00%
0/25 • Adverse events were collected for 15 months per patient.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place