Parkinson's Disease
Conditions
Keywords
Parkinson's Disease, Fatigue
Brief summary
The purpose of the research study is to determine if rasagiline is an effective treatment for fatigue in patients with Parkinson's disease (PD).
Detailed description
Despite the fact that fatigue affects 40-50% of all patients with PD and is a leading cause of disability, we currently do not have any effective treatments for this symptom. Rasagiline is a well-tolerated and effective treatment for the motor symptoms of PD. Rasagiline is a MAO-B inhibitor that may decrease the breakdown of dopamine. Many patients report an improvement in their energy levels when on this medication. A proven treatment for PD fatigue would significantly improve the quality of life for numerous patients and their caregivers.
Interventions
DRUGRasagiline
Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
DRUGPlacebo
Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. A clinical diagnosis of idiopathic PD by a movement disorders specialist. All subjects will be diagnosed using the UK Brain Bank criteria (Hughes et al., 1992). 2. Age between 40-85 years. 3. Able to sign and understand informed consent; and cognitively able to carry out the procedures in the study 4. Stable on all PD medications for at least 30 days; and psychotropic medications for at least 90 days. 5. Treatment naïve subjects who are appropriate candidates to begin MAO-inhibitor monotherapy as treatment for their PD may also be included in this study. 6. Fatigue Severity Scale ≥ 36 (KRupps et al., 1989)
Exclusion criteria
1. Clinically significant medical disease that is associated independently with fatigue (e.g. significant cardiac or pulmonary disease, anemia, obstructive sleep apnea, liver or kidney failure). 2. History of neurological illnesses other than PD or a history of a significant head trauma (involving unconsciousness). 3. Evidence of secondary or atypical parkinsonism as suggested by the presence of any of the following: 1) history of stroke(s), 2) exposure to toxins or neuroleptics, 3) history of encephalitis, 4) neurological signs of upper motor neuron disease, cerebellar involvement, supranuclear gaze palsy, or significant orthostatic hypotension. 4. MRI or CT scan with significant evidence of brain atrophy or other abnormalities (e.g. lacunar infarcts or iron deposits in the putamen. 5. Clinical diagnoses of dementia; or an MMSE score of \< 25. 6. Unstable, newly diagnosed, or newly treated (i.e. less than 3 months) major psychiatric disorder such as depression or anxiety 7. Beck's Depression Inventory score \>14. 8. Current or prior placement of Deep Brain Stimulator. 9. Currently taking an MAO-B inhibitor or medications which are used as fatigue treatments, including amantadine, modafinil, methylphenidate, atomoxetine or other psychostimulants. 10. Previously taken an MAO-B inhibitor for more than 2 weeks. 11. Hypersensitivity to rasagiline or its products 12. On mirtazapine, venlafaxine, regular use of compounds with vasoconstrictors, tramadol, meperidine, propoxyphene, dextromethorphan, St. John's wort, cyclobenzaprine 13. On omeprazole, ciprofloxacin or drugs that are metabolized through CYP1A2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Fatigue Impact Scale (MFIS) | Change from baseline to week 12 | The MFIS rates how much of a problem fatigue has caused the subjects during the past month, including the day of testing. It consists of 21 questions of fatigue on quality of life. Each subject is asked to circle the appropriate response for each item: 0=never, 1=rarely, 2=sometimes, 3=often, 4=always, 5=almost always. The minimum score is 0 and the maximum is 105. The higher the score, the more fatigue the subject. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multidimensional Fatigue Inventory (MFIS) | Change from baseline to week 12 | The Multidimensional Fatigue Inventory (MFIS) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Subjects are instructed to choose a number from 1 to 5 that indicates their degree of agreement with each statement where 1 indicates that it is true and 5 that it is not true. There are positive and negative statements in the questionnaire. The range is 1 to 100, the higher the number the higher the fatigue. |
| PD Quality of Life Scale (PDQ39) | Change from baseline to week 12 | PD Quality of Life Scale (PDQ39) is a 39-item questionnaire, which measures eight dimensions of health (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication and bodily discomfort) over the past 30 days. Dimension scores are coded on a scale of 0 (never) to 5 (always). The higher the score, the worse the quality of life affected by PD. The range for this test is 0 to 195. All eight dimensions are added for a total score. |
| Fatigue Severity Scale (FSS) | Change from baseline to week 12 | The Fatigue Severity Score consists of a nine-item questionnaire to identify common features of fatigue. Patients are instructed to choose a number from 1 to 7 that indicates their degree of agreement with each statement, where 1 = strongly disagree and 7 = strongly agree. Scores can range from a minimum of 9 to a maximum of 63. The higher the score, the more fatigue the subject. |
| Finger Tapping | Change from baseline to week 12 | The patient is asked to use the index finger on the side most affected by Parkinson's disease to tap for sixty seconds with the number of taps at 30 seconds and 60 seconds recorded. |
| Hand-grip Strength | Change from baseline to week 12 | The patients use the hand on the side most affected by Parkinson's disease to grip the dynamometer with as much strength as they can for 3 consecutive tries. The highest score will be their maximal voluntary contraction (MVC). The subject then rests for 60 seconds. The subject is asked to try to maintain 70% of their MVC and the duration the subject is able to maintain above 50% of their MVC is recorded. Immediately after the maintenance test, the subject performs three more MVCs and each one is recorded. These results are the duration the subject is able to maintain above 50% of their MVC. |
| Paced Auditory Serial Addition Test (PASAT) | Change from baseline to week 12 | The Paced Auditory Serial Addition Test (PASAT) is a neuropsychological test used to assess capacity and rate of information processing and sustained and divided attention. Where subjects are given a number (every 3 seconds for the first series and 2 seconds for the second series) and are asked to add the number they just heard with the number they heard before. This is a challenging task that involves working memory, attention, and arithmetic capabilities. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale - Subset: Sad | Change from baseline to week 12 | The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe). |
| Visual Analog Scale - Subset: Angry | Change from baseline to week 12 | The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe). |
| Visual Analog Scale - Subset: Energetic | Change from baseline to week 12 | The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe). |
| Parkinson's Disease Sleep Scale (PDSS) | Change from baseline to week 12 | The Parkinson's disease sleep scale (PDSS) is a 15-item visual analogue scale that assesses the profile of nocturnal disturbances in Parkinson's disease patients. The severity of symptoms of sleep over the past week is marked with a cross along a 10 cm line (labeled worst to best state). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptom severe and always experienced) to 10 (symptom-free). The maximum score for PDSS is 150. |
| Visual Analog Scale - Subset: Happy | Change from baseline to week 12 | The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe). |
| Visual Analog Scale - Subset: Tense | Change from baseline to week 12 | The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe). |
| Visual Analog Scale - Subset: Tired | Change from baseline to week 12 | The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe). |
| Marin Apathy Inventory (Apathy Evaluation Scale) | Change from baseline to week 12 | The Marin Apathy Inventory (Apathy Evaluation Scale) is a 14-item inventory measuring apathy of the subject over the past 2 to 4 weeks. Subjects are instructed to choose an answer from 0 to 3: 0=not at all, 1 = slightly, 2 = some, 3 = a lot, to questions related to apathy. The range would be 0 to 42, the higher the score the worse the apathy. |
| Visual Analog Scale - Subset: Afraid | Change from baseline to week 12 | The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe). |
| State-Trait Anxiety Inventory (STAI) | Change from baseline to week 12 | The State-Trait Anxiety Inventory (STAI) is 40-item psychological inventory based on a 4-point Likert scale. Higher scores are positively correlated with higher levels of anxiety. The range for this test is 0 to 160. |
| Becks Depression Inventory (BDI-II) | Change from baseline to week 12 | The Becks Depression Inventory (BDI-II) is a 21-question inventory measuring the severity of depression. Each subject is instructed to choose an answer on a scale value of 0 to 3 with the total score from 0 to 63. Higher total scores indicate more severe depressive symptoms. |
| Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III) | Change from baseline to week 12 | Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III)is a 14-question inventory measuring the motor functions of patients with Parkinson's Disease. Each subject is rated on a scale of 0 to 4 with the total score from 0 to 56. Higher total scores indicate more impairment of motor function. |
| Visual Analog Scale - Subset: Confused | Change from baseline to week 12 | The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rasagiline Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. | 16 |
| Sugar Pill Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks. | 14 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Rasagiline | Sugar Pill | Total |
|---|---|---|---|
| Age, Continuous | 68.67 years STANDARD_DEVIATION 7.39 | 65.43 years STANDARD_DEVIATION 6.42 | 67.1 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 16 participants | 14 participants | 30 participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 14 Participants |
| Sex: Female, Male Male | 11 Participants | 5 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 16 | 5 / 14 |
| serious Total, serious adverse events | 1 / 16 | 0 / 14 |
Outcome results
Primary
Modified Fatigue Impact Scale (MFIS)
The MFIS rates how much of a problem fatigue has caused the subjects during the past month, including the day of testing. It consists of 21 questions of fatigue on quality of life. Each subject is asked to circle the appropriate response for each item: 0=never, 1=rarely, 2=sometimes, 3=often, 4=always, 5=almost always. The minimum score is 0 and the maximum is 105. The higher the score, the more fatigue the subject.
Time frame: Change from baseline to week 12
Population: The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | Modified Fatigue Impact Scale (MFIS) | 12.92 units on a scale |
| Sugar Pill | Modified Fatigue Impact Scale (MFIS) | 12.69 units on a scale |
p-value: 0.8195% CI: [-9.13, 11.73]Regression, Linear
Secondary
Fatigue Severity Scale (FSS)
The Fatigue Severity Score consists of a nine-item questionnaire to identify common features of fatigue. Patients are instructed to choose a number from 1 to 7 that indicates their degree of agreement with each statement, where 1 = strongly disagree and 7 = strongly agree. Scores can range from a minimum of 9 to a maximum of 63. The higher the score, the more fatigue the subject.
Time frame: Change from baseline to week 12
Population: The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | Fatigue Severity Scale (FSS) | 12.38 units on a scale |
| Sugar Pill | Fatigue Severity Scale (FSS) | 2.25 units on a scale |
p-value: 0.2395% CI: [-2.75, 11.51]Regression, Linear
Secondary
Finger Tapping
The patient is asked to use the index finger on the side most affected by Parkinson's disease to tap for sixty seconds with the number of taps at 30 seconds and 60 seconds recorded.
Time frame: Change from baseline to week 12
Population: The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | Finger Tapping | .46 finger taps per sixty seconds |
| Sugar Pill | Finger Tapping | -0.23 finger taps per sixty seconds |
p-value: 0.4495% CI: [-0.56, 1.29]Regression, Linear
Secondary
Hand-grip Strength
The patients use the hand on the side most affected by Parkinson's disease to grip the dynamometer with as much strength as they can for 3 consecutive tries. The highest score will be their maximal voluntary contraction (MVC). The subject then rests for 60 seconds. The subject is asked to try to maintain 70% of their MVC and the duration the subject is able to maintain above 50% of their MVC is recorded. Immediately after the maintenance test, the subject performs three more MVCs and each one is recorded. These results are the duration the subject is able to maintain above 50% of their MVC.
Time frame: Change from baseline to week 12
Population: The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | Hand-grip Strength | -9.08 seconds |
| Sugar Pill | Hand-grip Strength | -8.36 seconds |
p-value: 0.8295% CI: [-17.59, 22.13]Regression, Linear
Secondary
Multidimensional Fatigue Inventory (MFIS)
The Multidimensional Fatigue Inventory (MFIS) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Subjects are instructed to choose a number from 1 to 5 that indicates their degree of agreement with each statement where 1 indicates that it is true and 5 that it is not true. There are positive and negative statements in the questionnaire. The range is 1 to 100, the higher the number the higher the fatigue.
Time frame: Change from baseline to week 12
Population: The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | Multidimensional Fatigue Inventory (MFIS) | 2.62 units on a scale |
| Sugar Pill | Multidimensional Fatigue Inventory (MFIS) | 6.83 units on a scale |
p-value: 0.7595% CI: [-8.37, 11.59]Regression, Linear
Secondary
Paced Auditory Serial Addition Test (PASAT)
The Paced Auditory Serial Addition Test (PASAT) is a neuropsychological test used to assess capacity and rate of information processing and sustained and divided attention. Where subjects are given a number (every 3 seconds for the first series and 2 seconds for the second series) and are asked to add the number they just heard with the number they heard before. This is a challenging task that involves working memory, attention, and arithmetic capabilities.
Time frame: Change from baseline to week 12
Population: The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | Paced Auditory Serial Addition Test (PASAT) | -11.31 units on a scale |
| Sugar Pill | Paced Auditory Serial Addition Test (PASAT) | -10.31 units on a scale |
p-value: 0.4295% CI: [-17.76, 7.43]Regression, Linear
Secondary
PD Quality of Life Scale (PDQ39)
PD Quality of Life Scale (PDQ39) is a 39-item questionnaire, which measures eight dimensions of health (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication and bodily discomfort) over the past 30 days. Dimension scores are coded on a scale of 0 (never) to 5 (always). The higher the score, the worse the quality of life affected by PD. The range for this test is 0 to 195. All eight dimensions are added for a total score.
Time frame: Change from baseline to week 12
Population: The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | PD Quality of Life Scale (PDQ39) | 7.54 units on a scale |
| Sugar Pill | PD Quality of Life Scale (PDQ39) | 5.67 units on a scale |
p-value: 0.5495% CI: [-4.18, 7.94]Regression, Linear
Other Pre-specified
Becks Depression Inventory (BDI-II)
The Becks Depression Inventory (BDI-II) is a 21-question inventory measuring the severity of depression. Each subject is instructed to choose an answer on a scale value of 0 to 3 with the total score from 0 to 63. Higher total scores indicate more severe depressive symptoms.
Time frame: Change from baseline to week 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | Becks Depression Inventory (BDI-II) | 3.69 units on a scale |
| Sugar Pill | Becks Depression Inventory (BDI-II) | 2.31 units on a scale |
p-value: 0.4595% CI: [-8.02, 3.59]Regression, Linear
Other Pre-specified
Marin Apathy Inventory (Apathy Evaluation Scale)
The Marin Apathy Inventory (Apathy Evaluation Scale) is a 14-item inventory measuring apathy of the subject over the past 2 to 4 weeks. Subjects are instructed to choose an answer from 0 to 3: 0=not at all, 1 = slightly, 2 = some, 3 = a lot, to questions related to apathy. The range would be 0 to 42, the higher the score the worse the apathy.
Time frame: Change from baseline to week 12
Population: The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | Marin Apathy Inventory (Apathy Evaluation Scale) | .23 units on a scale |
| Sugar Pill | Marin Apathy Inventory (Apathy Evaluation Scale) | .46 units on a scale |
p-value: 0.9395% CI: [-2.15, 2.36]Regression, Linear
Other Pre-specified
Parkinson's Disease Sleep Scale (PDSS)
The Parkinson's disease sleep scale (PDSS) is a 15-item visual analogue scale that assesses the profile of nocturnal disturbances in Parkinson's disease patients. The severity of symptoms of sleep over the past week is marked with a cross along a 10 cm line (labeled worst to best state). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptom severe and always experienced) to 10 (symptom-free). The maximum score for PDSS is 150.
Time frame: Change from baseline to week 12
Population: The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | Parkinson's Disease Sleep Scale (PDSS) | -13.46 units on a scale |
| Sugar Pill | Parkinson's Disease Sleep Scale (PDSS) | .64 units on a scale |
p-value: 0.5295% CI: [-19.31, 9.85]Regression, Linear
Other Pre-specified
State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory (STAI) is 40-item psychological inventory based on a 4-point Likert scale. Higher scores are positively correlated with higher levels of anxiety. The range for this test is 0 to 160.
Time frame: Change from baseline to week 12
Population: The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | State-Trait Anxiety Inventory (STAI) | 3.62 units on a scale |
| Sugar Pill | State-Trait Anxiety Inventory (STAI) | 6.08 units on a scale |
p-value: 0.5695% CI: [-19.74, 10.69]Regression, Linear
Other Pre-specified
Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III)
Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III)is a 14-question inventory measuring the motor functions of patients with Parkinson's Disease. Each subject is rated on a scale of 0 to 4 with the total score from 0 to 56. Higher total scores indicate more impairment of motor function.
Time frame: Change from baseline to week 12
Population: The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III) | 7.5 units on a scale |
| Sugar Pill | Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III) | -0.83 units on a scale |
p-value: 0.5895% CI: [-7.02, 12.55]Regression, Linear
Other Pre-specified
Visual Analog Scale - Subset: Afraid
The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).
Time frame: Change from baseline to week 12
Population: The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | Visual Analog Scale - Subset: Afraid | -.77 units on a scale |
| Sugar Pill | Visual Analog Scale - Subset: Afraid | -.83 units on a scale |
p-value: 0.8295% CI: [-1.05, 0.83]Regression, Linear
Other Pre-specified
Visual Analog Scale - Subset: Angry
The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).
Time frame: Change from baseline to week 12
Population: The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | Visual Analog Scale - Subset: Angry | .19 units on a scale |
| Sugar Pill | Visual Analog Scale - Subset: Angry | .33 units on a scale |
p-value: 0.8495% CI: [-0.71, 0.58]Regression, Linear
Other Pre-specified
Visual Analog Scale - Subset: Confused
The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).
Time frame: Change from baseline to week 12
Population: The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | Visual Analog Scale - Subset: Confused | -.35 units on a scale |
| Sugar Pill | Visual Analog Scale - Subset: Confused | -.21 units on a scale |
p-value: 0.9595% CI: [-1.04, 1.11]Regression, Linear
Other Pre-specified
Visual Analog Scale - Subset: Energetic
The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).
Time frame: Change from baseline to week 12
Population: The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | Visual Analog Scale - Subset: Energetic | -1.19 units on a scale |
| Sugar Pill | Visual Analog Scale - Subset: Energetic | -2.12 units on a scale |
p-value: 0.4495% CI: [-0.77, 1.76]Regression, Linear
Other Pre-specified
Visual Analog Scale - Subset: Happy
The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).
Time frame: Change from baseline to week 12
Population: The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | Visual Analog Scale - Subset: Happy | .04 units on a scale |
| Sugar Pill | Visual Analog Scale - Subset: Happy | -0.33 units on a scale |
p-value: 0.3195% CI: [-0.62, 1.9]Regression, Linear
Other Pre-specified
Visual Analog Scale - Subset: Sad
The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).
Time frame: Change from baseline to week 12
Population: The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | Visual Analog Scale - Subset: Sad | -.19 units on a scale |
| Sugar Pill | Visual Analog Scale - Subset: Sad | -.5 units on a scale |
p-value: 0.4895% CI: [-1.45, 0.69]Regression, Linear
Other Pre-specified
Visual Analog Scale - Subset: Tense
The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).
Time frame: Change from baseline to week 12
Population: The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | Visual Analog Scale - Subset: Tense | .25 units on a scale |
| Sugar Pill | Visual Analog Scale - Subset: Tense | .83 units on a scale |
p-value: 0.9495% CI: [-1.68, 1.56]Regression, Linear
Other Pre-specified
Visual Analog Scale - Subset: Tired
The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).
Time frame: Change from baseline to week 12
Population: The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rasagiline | Visual Analog Scale - Subset: Tired | .04 units on a scale |
| Sugar Pill | Visual Analog Scale - Subset: Tired | .75 units on a scale |
p-value: 0.7195% CI: [-2.06, 1.41]Regression, Linear