Trial Outcomes & Findings for Image Parkinson's Disease Progression Study (NCT NCT02789020)
NCT ID: NCT02789020
Last Updated: 2023-09-06
Results Overview
12-month study in PD to watch the effect of an Monoamine Oxidase-B inhibitor on the progressive increase of free-water accumulation in the substantia nigra. Recently, free-water diffusion MRI analysis using a bi-tensor model was developed to explicitly estimate the contribution of freely diffusing water molecules within the voxel. This free-water measure is expected to increase with atrophy-based neurodegeneration. Since substantia nigra degeneration occurs mostly in the posterior region of the substantia nigra in PD (ie. ventrolateral tier), we tested the hypothesis that free-water would be elevated in the posterior substantia nigra of PD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
Baseline and one-year
Results posted on
2023-09-06
Participant Flow
96 participants diagnosed with PD signed the informed consent document for the study. 6 of these individuals did not complete the study protocol for a variety of reasons: 1 person revealed he had a prior stroke so he was disqualified at the visit, 2 people were excluded due to space restrictions in the MRI, and 3 people withdrew due to claustrophobia related to the MRI. Therefore, out of the 96 people who signed the consent (were enrolled), only 90 peoples' data were included/randomized.
Participant milestones
| Measure |
Rasagiline
This group will receive a 1 mg rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Rasagiline: Rasagiline will be taken for one year at the dose of 1mg a day. and subjects will undergo functional and structural brain imaging to determine if rasagiline is slowing the progression of Parkinson's Disease in the brain.
Magnetic Resonance Imaging: This test will be performed at baseline and one year.
functional Magnetic Resonance Imaging: This test will be performed at baseline and one year.
Physical Function Performance Test: This test will be performed at baseline and one year.
|
Placebo
This group will receive a placebo tablet in the same forum as the rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Placebo: A placebo tablet will be taken for one year, once a day, and at the same dose of 1mg. subjects will undergo functional and structural brain imaging to be compared with the group taking the rasagiline intervention.
Magnetic Resonance Imaging: This test will be performed at baseline and one year.
functional Magnetic Resonance Imaging: This test will be performed at baseline and one year.
Physical Function Performance Test: This test will be performed at baseline and one year.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
39
|
40
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Rasagiline
This group will receive a 1 mg rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Rasagiline: Rasagiline will be taken for one year at the dose of 1mg a day. and subjects will undergo functional and structural brain imaging to determine if rasagiline is slowing the progression of Parkinson's Disease in the brain.
Magnetic Resonance Imaging: This test will be performed at baseline and one year.
functional Magnetic Resonance Imaging: This test will be performed at baseline and one year.
Physical Function Performance Test: This test will be performed at baseline and one year.
|
Placebo
This group will receive a placebo tablet in the same forum as the rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Placebo: A placebo tablet will be taken for one year, once a day, and at the same dose of 1mg. subjects will undergo functional and structural brain imaging to be compared with the group taking the rasagiline intervention.
Magnetic Resonance Imaging: This test will be performed at baseline and one year.
functional Magnetic Resonance Imaging: This test will be performed at baseline and one year.
Physical Function Performance Test: This test will be performed at baseline and one year.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
Baseline Characteristics
Image Parkinson's Disease Progression Study
Baseline characteristics by cohort
| Measure |
Rasagiline
n=45 Participants
This group will receive a 1 mg rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Rasagiline: Rasagiline will be taken for one year at the dose of 1mg a day. and subjects will undergo functional and structural brain imaging to determine if rasagiline is slowing the progression of Parkinson's Disease in the brain.
Magnetic Resonance Imaging: This test will be performed at baseline and one year.
functional Magnetic Resonance Imaging: This test will be performed at baseline and one year.
Physical Function Performance Test: This test will be performed at baseline and one year.
|
Placebo
n=45 Participants
This group will receive a placebo tablet in the same forum as the rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Placebo: A placebo tablet will be taken for one year, once a day, and at the same dose of 1mg. subjects will undergo functional and structural brain imaging to be compared with the group taking the rasagiline intervention.
Magnetic Resonance Imaging: This test will be performed at baseline and one year.
functional Magnetic Resonance Imaging: This test will be performed at baseline and one year.
Physical Function Performance Test: This test will be performed at baseline and one year.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Age, Continuous
|
65.02 years
STANDARD_DEVIATION 7.77 • n=5 Participants
|
63.44 years
STANDARD_DEVIATION 8.48 • n=7 Participants
|
64.23 years
STANDARD_DEVIATION 8.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Montreal Cognitive Assessment
|
26.64 units on a scale
STANDARD_DEVIATION 2.17 • n=5 Participants
|
25.82 units on a scale
STANDARD_DEVIATION 2.77 • n=7 Participants
|
26.23 units on a scale
STANDARD_DEVIATION 2.50 • n=5 Participants
|
|
Hamilton Rating Scale for Depression
|
5.09 units on a scale
STANDARD_DEVIATION 4.38 • n=5 Participants
|
7.02 units on a scale
STANDARD_DEVIATION 6.02 • n=7 Participants
|
6.06 units on a scale
STANDARD_DEVIATION 5.33 • n=5 Participants
|
|
Hamilton Anxiety Rating Scale
|
8.53 units on a scale
STANDARD_DEVIATION 8.04 • n=5 Participants
|
10.69 units on a scale
STANDARD_DEVIATION 7.94 • n=7 Participants
|
9.64 units on a scale
STANDARD_DEVIATION 8.02 • n=5 Participants
|
|
Parkinson's Disease Questionnaire (PDQ-39)
|
18.28 units on a scale
STANDARD_DEVIATION 18.84 • n=5 Participants
|
25.93 units on a scale
STANDARD_DEVIATION 20.36 • n=7 Participants
|
22.19 units on a scale
STANDARD_DEVIATION 19.90 • n=5 Participants
|
|
Movement Disorders Society UPDRS
|
29.62 units on a scale
STANDARD_DEVIATION 10.87 • n=5 Participants
|
32.76 units on a scale
STANDARD_DEVIATION 12.42 • n=7 Participants
|
31.19 units on a scale
STANDARD_DEVIATION 11.71 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and one-year12-month study in PD to watch the effect of an Monoamine Oxidase-B inhibitor on the progressive increase of free-water accumulation in the substantia nigra. Recently, free-water diffusion MRI analysis using a bi-tensor model was developed to explicitly estimate the contribution of freely diffusing water molecules within the voxel. This free-water measure is expected to increase with atrophy-based neurodegeneration. Since substantia nigra degeneration occurs mostly in the posterior region of the substantia nigra in PD (ie. ventrolateral tier), we tested the hypothesis that free-water would be elevated in the posterior substantia nigra of PD.
Outcome measures
| Measure |
Rasagiline
n=45 Participants
This group will receive a 1 mg rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Rasagiline: Rasagiline will be taken for one year at the dose of 1mg a day. and subjects will undergo functional and structural brain imaging to determine if rasagiline is slowing the progression of Parkinson's Disease in the brain.
Magnetic Resonance Imaging: This test will be performed at baseline and one year.
functional Magnetic Resonance Imaging: This test will be performed at baseline and one year.
Physical Function Performance Test: This test will be performed at baseline and one year.
|
Placebo
n=45 Participants
This group will receive a placebo tablet in the same forum as the rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Placebo: A placebo tablet will be taken for one year, once a day, and at the same dose of 1mg. subjects will undergo functional and structural brain imaging to be compared with the group taking the rasagiline intervention.
Magnetic Resonance Imaging: This test will be performed at baseline and one year.
functional Magnetic Resonance Imaging: This test will be performed at baseline and one year.
Physical Function Performance Test: This test will be performed at baseline and one year.
|
|---|---|---|
|
Change in Free-water Accumulation in the Substantia Nigra
|
0.0009 arbitrary units (A.U.s)
Standard Deviation 0.01
|
0.0041 arbitrary units (A.U.s)
Standard Deviation 0.01
|
PRIMARY outcome
Timeframe: Baseline and one-yearPopulation: The values below represent the BOLD signal in SMA.
12-month study in PD to watch the effect of an MAO-B inhibitor on BOLD signal in the posterior putamen, M1, and SMA.
Outcome measures
| Measure |
Rasagiline
n=45 Participants
This group will receive a 1 mg rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Rasagiline: Rasagiline will be taken for one year at the dose of 1mg a day. and subjects will undergo functional and structural brain imaging to determine if rasagiline is slowing the progression of Parkinson's Disease in the brain.
Magnetic Resonance Imaging: This test will be performed at baseline and one year.
functional Magnetic Resonance Imaging: This test will be performed at baseline and one year.
Physical Function Performance Test: This test will be performed at baseline and one year.
|
Placebo
n=45 Participants
This group will receive a placebo tablet in the same forum as the rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Placebo: A placebo tablet will be taken for one year, once a day, and at the same dose of 1mg. subjects will undergo functional and structural brain imaging to be compared with the group taking the rasagiline intervention.
Magnetic Resonance Imaging: This test will be performed at baseline and one year.
functional Magnetic Resonance Imaging: This test will be performed at baseline and one year.
Physical Function Performance Test: This test will be performed at baseline and one year.
|
|---|---|---|
|
Change in Blood Oxygen Level-dependent(BOLD) Signal in the Posterior Putamen, M1, and Supplementary Motor Area(SMA).
|
-0.054 arbitrary units (A.U.s)
Standard Deviation 0.315
|
-0.086 arbitrary units (A.U.s)
Standard Deviation 0.251
|
SECONDARY outcome
Timeframe: Baseline and one-yearMotor testing batteries such as the Purdue Pegboard Test will be administered to measure changes in the progression of the PD motor symptoms and bradykinesia.
Outcome measures
| Measure |
Rasagiline
n=45 Participants
This group will receive a 1 mg rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Rasagiline: Rasagiline will be taken for one year at the dose of 1mg a day. and subjects will undergo functional and structural brain imaging to determine if rasagiline is slowing the progression of Parkinson's Disease in the brain.
Magnetic Resonance Imaging: This test will be performed at baseline and one year.
functional Magnetic Resonance Imaging: This test will be performed at baseline and one year.
Physical Function Performance Test: This test will be performed at baseline and one year.
|
Placebo
n=45 Participants
This group will receive a placebo tablet in the same forum as the rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Placebo: A placebo tablet will be taken for one year, once a day, and at the same dose of 1mg. subjects will undergo functional and structural brain imaging to be compared with the group taking the rasagiline intervention.
Magnetic Resonance Imaging: This test will be performed at baseline and one year.
functional Magnetic Resonance Imaging: This test will be performed at baseline and one year.
Physical Function Performance Test: This test will be performed at baseline and one year.
|
|---|---|---|
|
Changes in Parkinson's Disease Motor Symptoms and Bradykinesia
|
1.04 count of pegs
Standard Deviation 3.15
|
0.689 count of pegs
Standard Deviation 3.94
|
SECONDARY outcome
Timeframe: Changes from baseline to 1 yearParticipants will use their hand to squeeze an MRI compatible grip force transducer in the MRI unit.
Outcome measures
| Measure |
Rasagiline
n=45 Participants
This group will receive a 1 mg rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Rasagiline: Rasagiline will be taken for one year at the dose of 1mg a day. and subjects will undergo functional and structural brain imaging to determine if rasagiline is slowing the progression of Parkinson's Disease in the brain.
Magnetic Resonance Imaging: This test will be performed at baseline and one year.
functional Magnetic Resonance Imaging: This test will be performed at baseline and one year.
Physical Function Performance Test: This test will be performed at baseline and one year.
|
Placebo
n=45 Participants
This group will receive a placebo tablet in the same forum as the rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Placebo: A placebo tablet will be taken for one year, once a day, and at the same dose of 1mg. subjects will undergo functional and structural brain imaging to be compared with the group taking the rasagiline intervention.
Magnetic Resonance Imaging: This test will be performed at baseline and one year.
functional Magnetic Resonance Imaging: This test will be performed at baseline and one year.
Physical Function Performance Test: This test will be performed at baseline and one year.
|
|---|---|---|
|
Changes Between the Groups on fMRI
|
-0.054 unitless
Standard Deviation 0.315
|
-0.086 unitless
Standard Deviation 0.251
|
Adverse Events
Rasagiline
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rasagiline
n=45 participants at risk
This group will receive a 1 mg rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Rasagiline: Rasagiline will be taken for one year at the dose of 1mg a day. and subjects will undergo functional and structural brain imaging to determine if rasagiline is slowing the progression of Parkinson's Disease in the brain.
Magnetic Resonance Imaging: This test will be performed at baseline and one year.
functional Magnetic Resonance Imaging: This test will be performed at baseline and one year.
Physical Function Performance Test: This test will be performed at baseline and one year.
|
Placebo
n=45 participants at risk
This group will receive a placebo tablet in the same forum as the rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Placebo: A placebo tablet will be taken for one year, once a day, and at the same dose of 1mg. subjects will undergo functional and structural brain imaging to be compared with the group taking the rasagiline intervention.
Magnetic Resonance Imaging: This test will be performed at baseline and one year.
functional Magnetic Resonance Imaging: This test will be performed at baseline and one year.
Physical Function Performance Test: This test will be performed at baseline and one year.
|
|---|---|---|
|
Vascular disorders
Orthostatic Hypotension
|
2.2%
1/45 • Number of events 1 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
0.00%
0/45 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
|
Metabolism and nutrition disorders
Weight Loss
|
2.2%
1/45 • Number of events 1 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
0.00%
0/45 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
|
Social circumstances
Hypersexuality
|
2.2%
1/45 • Number of events 1 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
0.00%
0/45 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
|
Nervous system disorders
Headaches
|
2.2%
1/45 • Number of events 1 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
0.00%
0/45 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
|
Musculoskeletal and connective tissue disorders
Falls
|
2.2%
1/45 • Number of events 1 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
2.2%
1/45 • Number of events 1 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
|
Endocrine disorders
Hair Loss
|
2.2%
1/45 • Number of events 1 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
0.00%
0/45 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/45 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
2.2%
1/45 • Number of events 1 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
|
Musculoskeletal and connective tissue disorders
Joint Pain/Stiffness
|
2.2%
1/45 • Number of events 1 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
2.2%
1/45 • Number of events 1 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
|
Nervous system disorders
Vertigo/Dizziness
|
0.00%
0/45 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
2.2%
1/45 • Number of events 1 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
0.00%
0/45 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
2.2%
1/45 • Number of events 1 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
|
Vascular disorders
Edema
|
0.00%
0/45 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
2.2%
1/45 • Number of events 1 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
|
Social circumstances
Fatigue
|
2.2%
1/45 • Number of events 1 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
4.4%
2/45 • Number of events 2 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
|
Nervous system disorders
Light-Headedness
|
4.4%
2/45 • Number of events 2 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
2.2%
1/45 • Number of events 1 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
|
Nervous system disorders
Increased Resting Tremor
|
2.2%
1/45 • Number of events 1 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
0.00%
0/45 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
|
Nervous system disorders
Dizziness and Light-Headedness
|
2.2%
1/45 • Number of events 1 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
|
0.00%
0/45 • 1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place