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The purpose of the research study is to determine if rasagiline is an effective treatment for fatigue in patients with Parkinson's disease (PD).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sugar pill | Placebo Comparator | Placebo tablet, 1 per day, duration is approximately 12 weeks. |
|
| rasagiline | Active Comparator | Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rasagiline | Drug | Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene A Malaty, MD | University of Florida Department of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz outpatient Pavilion | Aurora | Colorado | 80045 | United States | ||
| Shands and University of Florida Medical Plaza |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Sugar Pill |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to week 12 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient ischemic attack | Nervous system disorders | CTCAE 4.03 | Non-systematic Assessment | Thought by PI to be unlikely related to study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| exostosis foot | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Non-systematic Assessment | bone spur on left foot. Moderate in severity. Thought by the PI to be unrelated to the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Irene A. Malaty, MD | University of Florida Center for Movement Disorders and Neurorestoration | 352-273-5550 | Irene.Malaty@neurology.ufl.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C031967 | rasagiline |
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| Placebo | Drug | Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks. |
|
| Change from baseline to week 12 |
| 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. | Change from baseline to week 12 |
| 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. | Change from baseline to week 12 |
| 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. | Change from baseline to week 12 |
| 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. | Change from baseline to week 12 |
| 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. | Change from baseline to week 12 |
| Change from baseline to week 12 |
| 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. | Change from baseline to week 12 |
| 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). | Change from baseline to week 12 |
| 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. | Change from baseline to week 12 |
| 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. | Change from baseline to week 12 |
| 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. | Change from baseline to week 12 |
| 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). | Change from baseline to week 12 |
| 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). | Change from baseline to week 12 |
| 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). | Change from baseline to week 12 |
| 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). | Change from baseline to week 12 |
| 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). | Change from baseline to week 12 |
| 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). | Change from baseline to week 12 |
| 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). | Change from baseline to week 12 |
| Gainesville |
| Florida |
| 32610 |
| United States |
| Cleveland Clinic Center for Neurological Restoration | Cleveland | Ohio | 44195 | United States |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to week 12 |
|
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to week 12 |
|
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to week 12 |
|
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to week 12 |
|
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | finger taps per sixty seconds | Change from baseline to week 12 |
|
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | seconds | Change from baseline to week 12 |
|
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|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to week 12 |
|
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to week 12 |
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|
|
| 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). | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to week 12 |
|
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|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to week 12 |
|
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|
|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to week 12 |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to week 12 |
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|
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| 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). | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to week 12 |
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|
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| 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). | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to week 12 |
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|
|
| 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). | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to week 12 |
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| 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). | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to week 12 |
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| 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). | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to week 12 |
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| 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). | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to week 12 |
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| 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). | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to week 12 |
|
|
|
|
| 1 |
| 16 |
| 9 |
| 16 |
| EG001 | 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. | 0 | 14 | 5 | 14 |
|
|
| dizziness | Nervous system disorders | CTCAE 4.03 | Non-systematic Assessment | Intermittent dizzy spells reported by patient. PI thought it unlikely to be related to study medication. |
|
| Headache | Nervous system disorders | CTCAE 4.03 | Non-systematic Assessment | Patient reported having headaches occasionally in the past but now having worsened headache meaning the pain was slightly worse when he had headaches. The PI thought it unlikely to be related to the study medication. |
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| depression | Psychiatric disorders | CTCAE 4.03 | Non-systematic Assessment | Patient on active drug had depression already and reported a worsening of depression symptoms. PI thought to be unrelated to the study medication. Sub-I felt patient on placebo was unlikely related to study medication. |
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| insomnia | Psychiatric disorders | CTCAE 4.03 | Non-systematic Assessment | PI thought it unlikely to be related to the study medication. |
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| hypertension | Vascular disorders | CTCAE 4.03 | Non-systematic Assessment |
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| thrombolembolic event | Vascular disorders | CTCAE 4.03 | Non-systematic Assessment | blood clot in left calf reported by patient. Thought by sub-I to be unrelated. |
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| skin infection | Infections and infestations | CTCAE 4.03 | Non-systematic Assessment | infection on left arm. Thought by sub-I to be unrelated to study medication. |
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| urinary urgency | Renal and urinary disorders | CTCAE 4.03 | Non-systematic Assessment | Patient reported worsened urinary urgency. Thought by PI to be unrelated to study medication. |
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| anxiety | Psychiatric disorders | CTCAE 4.03 | Non-systematic Assessment | Thought to be possibly related to study drug by sub-I. |
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| urinary tract infection | Infections and infestations | CTCAE 4.03 | Non-systematic Assessment | PI and sub-I each thought their patient's UTI was unlikely related to the study medication. |
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| nausea | Gastrointestinal disorders | CTCAE 4.03 | Non-systematic Assessment | The sub-I thought the 2 instances in one of the patients affected was possibly related to the study medication and the other patient's nausea was probably related to the study medication. |
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| fall | Injury, poisoning and procedural complications | CTCAE 4.03 | Non-systematic Assessment | Thought by PI to be unrelated to study medication. |
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| upper respiratory infection | Infections and infestations | CTCAE 4.03 | Non-systematic Assessment | Sub-I thought it unlikely hese were related to the study medication. |
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| fatigue | General disorders | CTCAE 4.03 | Non-systematic Assessment | Two patients reported worsened/increased fatigue which was thought by sub-I and PI unlikely to be related to study medication. |
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| Fever | General disorders | CTCAE 4.03 | Non-systematic Assessment | Patient reported fever only in the evening. PI thought it unlikely to be related to study medication. |
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| myalgia | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Non-systematic Assessment | Body aches considered unlikely to be related to study medication by sub-I. |
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| paresthesia | Nervous system disorders | CTCAE 4.03 | Non-systematic Assessment | patient reported mild numbness in fingers - bilateral. Sub-I thought to be possibly related to study medication. |
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| gait disturbance | General disorders | CTCAE 4.03 | Non-systematic Assessment | Patient reported increased freezing. Thought to be unrelated to study medication by the PI. |
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| arthralgia | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Non-systematic Assessment | Patient reported right hip pain. Thought by PI to be unlikely related to study medication. |
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| Gastrointestinal disorders - other, diverticulitis | Gastrointestinal disorders | CTCAE 4.03 | Non-systematic Assessment | Diverticulitis thought by sub-I to be unlikely related to study medication. |
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| Neoplasms benign, malignant and unspecified, other - squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 4.03 | Non-systematic Assessment | patient had a squamous cell carcinoma removed from right hand. Though by PI to be unrelated to study medication. |
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| pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Non-systematic Assessment | Patient reported muscle cramp in right leg. Sub-I thought to be possibly related to study medication. |
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| injury, poisoning and procedureal complications, other - skin laceration | Injury, poisoning and procedural complications | CTCAE 4.03 | Non-systematic Assessment | patient reported a skin tear (from tape) on left arm. Sub-I thought to be unrelated to study medication. |
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| extrapyramidal disorder | Nervous system disorders | CTCAE 4.03 | Non-systematic Assessment | patient reported dyskinesias. Thought by PI to be possibly related to study medication. |
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| urinary tract pain | Renal and urinary disorders | CTCAE 4.03 | Non-systematic Assessment | Patient reported burning upon urination. PI thought it to be unrelated to study medication. |
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Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |