Trial Outcomes & Findings for Rasagiline for the Symptomatic Treatment of Fatigue in Parkinson's Disease (NCT NCT01168596)

NCT ID: NCT01168596

Last Updated: 2014-01-10

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: Change from baseline to week 12
• Results posted on: 2014-01-10

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	16	14
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	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.	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.
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

Rasagiline for the Symptomatic Treatment of Fatigue in Parkinson's Disease

Baseline characteristics by cohort

Measure	Rasagiline n=16 Participants 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.	Sugar Pill n=14 Participants 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.	Total n=30 Participants Total of all reporting groups
Age, Continuous	68.67 years STANDARD_DEVIATION 7.39 • n=5 Participants	65.43 years STANDARD_DEVIATION 6.42 • n=7 Participants	67.1 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	14 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rasagiline n=15 Participants 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.	Sugar Pill n=14 Participants 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.
Modified Fatigue Impact Scale (MFIS)	12.92 units on a scale Interval 0.68 to 25.16	12.69 units on a scale Interval 1.4 to 23.98

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rasagiline n=15 Participants 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.	Sugar Pill n=13 Participants 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.
Fatigue Severity Scale (FSS)	12.38 units on a scale Interval 4.37 to 20.4	2.25 units on a scale Interval -5.48 to 9.98

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rasagiline n=15 Participants 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.	Sugar Pill n=13 Participants 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.
Multidimensional Fatigue Inventory (MFIS)	2.62 units on a scale Interval -4.15 to 9.38	6.83 units on a scale Interval -0.02 to 13.69

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rasagiline n=15 Participants 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.	Sugar Pill n=14 Participants 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.
PD Quality of Life Scale (PDQ39)	7.54 units on a scale Interval -1.61 to 16.69	5.67 units on a scale Interval -1.87 to 13.21

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rasagiline n=15 Participants 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.	Sugar Pill n=14 Participants 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.
Paced Auditory Serial Addition Test (PASAT)	-11.31 units on a scale Interval -18.69 to -3.93	-10.31 units on a scale Interval -20.27 to -0.35

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rasagiline n=15 Participants 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.	Sugar Pill n=14 Participants 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.
Finger Tapping	.46 finger taps per sixty seconds Interval -0.038 to 1.3	-0.23 finger taps per sixty seconds Interval -0.89 to 0.43

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rasagiline n=15 Participants 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.	Sugar Pill n=14 Participants 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.
Hand-grip Strength	-9.08 seconds Interval -23.86 to 5.69	-8.36 seconds Interval -17.42 to 0.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rasagiline n=15 Participants 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.	Sugar Pill n=14 Participants 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.
Parkinson's Disease Sleep Scale (PDSS)	-13.46 units on a scale Interval -24.04 to -2.88	.64 units on a scale Interval -9.1 to 10.38

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rasagiline n=15 Participants 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.	Sugar Pill n=14 Participants 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.
Marin Apathy Inventory (Apathy Evaluation Scale)	.23 units on a scale Interval -1.21 to 1.67	.46 units on a scale Interval -1.22 to 2.15

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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).

Outcome measures

Measure	Rasagiline n=15 Participants 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.	Sugar Pill n=14 Participants 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.
Visual Analog Scale - Subset: Afraid	-.77 units on a scale Interval -2.08 to 0.55	-.83 units on a scale Interval -1.91 to 0.24

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rasagiline n=15 Participants 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.	Sugar Pill n=14 Participants 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.
State-Trait Anxiety Inventory (STAI)	3.62 units on a scale Interval -7.37 to 14.6	6.08 units on a scale Interval -5.56 to 17.72

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Rasagiline n=16 Participants 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.	Sugar Pill n=14 Participants 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.
Becks Depression Inventory (BDI-II)	3.69 units on a scale Interval -1.89 to 9.27	2.31 units on a scale Interval 0.01 to 4.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rasagiline n=15 Participants 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.	Sugar Pill n=14 Participants 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.
Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III)	7.5 units on a scale Interval 0.6 to 14.4	-0.83 units on a scale Interval -4.71 to 3.04

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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).

Outcome measures

Measure	Rasagiline n=15 Participants 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.	Sugar Pill n=14 Participants 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.
Visual Analog Scale - Subset: Confused	-.35 units on a scale Interval -1.72 to 1.03	-.21 units on a scale Interval -1.39 to 0.98

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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).

Outcome measures

Measure	Rasagiline n=15 Participants 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.	Sugar Pill n=14 Participants 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.
Visual Analog Scale - Subset: Sad	-.19 units on a scale Interval -2.52 to 2.14	-.5 units on a scale Interval -1.82 to 0.82

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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).

Outcome measures

Measure	Rasagiline n=15 Participants 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.	Sugar Pill n=14 Participants 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.
Visual Analog Scale - Subset: Angry	.19 units on a scale Interval -0.81 to 1.2	.33 units on a scale Interval -0.55 to 1.21

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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).

Outcome measures

Measure	Rasagiline n=15 Participants 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.	Sugar Pill n=14 Participants 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.
Visual Analog Scale - Subset: Energetic	-1.19 units on a scale Interval -3.27 to 0.88	-2.12 units on a scale Interval -4.33 to 0.08

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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).

Outcome measures

Measure	Rasagiline n=15 Participants 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.	Sugar Pill n=14 Participants 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.
Visual Analog Scale - Subset: Tired	.04 units on a scale Interval -2.59 to 2.67	.75 units on a scale Interval -1.32 to 2.82

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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).

Outcome measures

Measure	Rasagiline n=15 Participants 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.	Sugar Pill n=14 Participants 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.
Visual Analog Scale - Subset: Happy	.04 units on a scale Interval -3.14 to 3.22	-0.33 units on a scale Interval -2.77 to 2.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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).

Outcome measures

Measure	Rasagiline n=14 Participants 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.	Sugar Pill n=14 Participants 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.
Visual Analog Scale - Subset: Tense	.25 units on a scale Interval -1.02 to 1.52	.83 units on a scale Interval -0.47 to 2.13

Adverse Events

Rasagiline

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rasagiline n=16 participants at risk 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.	Sugar Pill n=14 participants at risk 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.
Nervous system disorders Transient ischemic attack	6.2% 1/16 • Number of events 1	0.00% 0/14

Other adverse events

Measure	Rasagiline n=16 participants at risk 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.	Sugar Pill n=14 participants at risk 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.
Musculoskeletal and connective tissue disorders exostosis foot	6.2% 1/16 • Number of events 1	0.00% 0/14
Nervous system disorders dizziness	6.2% 1/16 • Number of events 1	0.00% 0/14
Nervous system disorders Headache	6.2% 1/16 • Number of events 1	14.3% 2/14 • Number of events 3
Psychiatric disorders depression	6.2% 1/16 • Number of events 1	7.1% 1/14 • Number of events 1
Psychiatric disorders insomnia	6.2% 1/16 • Number of events 1	0.00% 0/14
Vascular disorders hypertension	0.00% 0/16	7.1% 1/14 • Number of events 1
Vascular disorders thrombolembolic event	6.2% 1/16 • Number of events 1	0.00% 0/14
Infections and infestations skin infection	6.2% 1/16 • Number of events 1	0.00% 0/14
Renal and urinary disorders urinary urgency	0.00% 0/16	7.1% 1/14 • Number of events 1
Psychiatric disorders anxiety	0.00% 0/16	7.1% 1/14 • Number of events 1
Infections and infestations urinary tract infection	0.00% 0/16	14.3% 2/14 • Number of events 2
Gastrointestinal disorders nausea	6.2% 1/16 • Number of events 1	7.1% 1/14 • Number of events 2
Injury, poisoning and procedural complications fall	6.2% 1/16 • Number of events 1	0.00% 0/14
Infections and infestations upper respiratory infection	12.5% 2/16 • Number of events 2	0.00% 0/14
General disorders fatigue	6.2% 1/16 • Number of events 1	7.1% 1/14 • Number of events 1
General disorders Fever	6.2% 1/16 • Number of events 1	0.00% 0/14
Musculoskeletal and connective tissue disorders myalgia	6.2% 1/16 • Number of events 1	0.00% 0/14
Nervous system disorders paresthesia	0.00% 0/16	7.1% 1/14 • Number of events 1
General disorders gait disturbance	6.2% 1/16 • Number of events 1	0.00% 0/14
Musculoskeletal and connective tissue disorders arthralgia	0.00% 0/16	7.1% 1/14 • Number of events 1
Gastrointestinal disorders Gastrointestinal disorders - other, diverticulitis	6.2% 1/16 • Number of events 1	0.00% 0/14
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified, other - squamous cell carcinoma	6.2% 1/16 • Number of events 1	0.00% 0/14
Musculoskeletal and connective tissue disorders pain in extremity	0.00% 0/16	7.1% 1/14 • Number of events 1
Injury, poisoning and procedural complications injury, poisoning and procedureal complications, other - skin laceration	6.2% 1/16 • Number of events 1	0.00% 0/14
Nervous system disorders extrapyramidal disorder	6.2% 1/16 • Number of events 1	0.00% 0/14
Renal and urinary disorders urinary tract pain	0.00% 0/16	7.1% 1/14 • Number of events 1

Additional Information

Irene A. Malaty, MD

University of Florida Center for Movement Disorders and Neurorestoration

Phone: 352-273-5550

Email: Irene.Malaty@neurology.ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place