Idiopathic Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Moderate to Severe Parkinson's Disease
Brief summary
This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinson's Disease. While on this study, participants will continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in this group.
Interventions
Istradefylline 40 mg and placebo
Istradefylline 20 mg and placebo
DRUGPlacebo
Placebo
Sponsors
Kyowa Hakko Kirin Pharma, Inc.
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 30 years of age or older. * UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD * PD Stages 2-4 in the ON state for Modified Hoehn and Yahr Scale. * On levodopa therapy for at least 1 year with beneficial clinical response at the baseline visit * Taking at least 400mg levodopa combination daily and on stable regimen of any other anti-Parkinsonian drugs (MAO-B, COMT, DA) for at least 2 weeks prior to randomization * Stable dopaminergic regimen for at least 4 weeks immediately prior to randomization * Documented end-of-dose wearing-off and levodopa-induced dyskinesia * Have an average of two hours of OFF time per day
Exclusion criteria
* Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion. * Subject who have had neurosurgical operation for PD * Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers * Subjects who smoke \> 5 cigarettes/day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12 | Baseline, Week 2, Week 6, Week 10 and Week 12. | Based on the 24-hour ON/OFF patient diary data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III); | Baseline, Week 2, Week 6, Week 10 and Week 12. | The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part III assesses the motor signs of Parkinson's Disease with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part III is 0 to 68. The lower the score, the more favorable the response. |
| Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II) | Baseline, Week 2, Week 6, Week 10 and Week 12. | The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part II is a self-evaluation of the activities of daily life (ADL) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part II is 0 to 52. The lower the score, the more favorable the response. |
| Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I) | Baseline, Week 2, Week 6, Week 10 and Week 12. | The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part I is the evaluation of mentation, behavior, and mood with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part I is 0 to 16. The lower the score, the more favorable the response. |
| Total UPDRS (Parts I + II + III); | Baseline, Week 2, Week 6, Week 10 and Week 12. | The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total possible score range for all parts combined is 0 to 136. The lower the score, the more favorable the response. |
| Patient Global Impression - Improvement (PGI-I) Scale | Baseline, Week 2, Week 6, Week 10, Week 12 and 30-day FU visit | The key symptom on the PGI-I was evaluated at baseline and subsequent post-baseline visits for the subject's overall condition and the symptoms of fatigue, sleep, motivation to get things done, and each subject's key symptom. Subjects rated each on a scale of 1 to 5 for change from baseline utilizing the following scale: * 1 = Moderate improvement (or greater) * 2 = Mild improvement * 3 = No change from baseline * 4 = Mild deterioration * 5 = Moderate deterioration (or greater) A lower number is a better outcome. Overall condition is presented below. |
| Total Hours of ON Time Per Day Without Troublesome Dyskinesia | Baseline, Week 2, Week 6, Week 10 and Week 12. | Based on Patient's ON/OFF Diary |
| Percentage of Awake Time Per Day Spent in the OFF State | Baseline, Week 2, Week 6, Week 10 and Week 12. | — |
| Percentage of ON Time Per Day Without Troublesome Dyskinesia. | Baseline, Week 2, Week 6, Week 10 and Week 12. | — |
| Montreal Cognitive Assessment (MoCA) | Baseline and Week 12. | The Montreal Cognitive Assessment (MoCA) assesses different cognitive domains, broken down as follows: Visuospatial and executive functioning: 5 points Animal Naming: 3 points Attention: 6 points Language: 3 points Abstraction: 2 points Delayed recall (short-term memory): 5 points Orientation: 6 points Scores can range from 0 to 30. A score of 26 or above is considered normal. |
| Beck Depression Inventory (BDI) | Baseline and Week 12. | The Beck Depression Inventory is a 21-question test that measures the severity of depression. Subjects rated each on a scale of 0 to 3 for change from baseline utilizing the following scale: * 0 = I do not feel sad * 1 = I feel sad * 2 = I am sad all the time and I can't snap out of it * 3 = I am so sad or unhappy that I can't stand it The test is scored for each question using the above scale to determine the severity of depression. Scoring is as shown below: * 0 to 9: minimal depression * 10 to 18: mild depression * 19 to 29: moderate depression * 30 to 63: severe depression |
| Sleep Time in Hours Per Day Based Upon 24-hour Diaries. | Baseline, Week 2, Week 6, Week 10 and Week 12. | — |
Countries
Canada, Czechia, Germany, Israel, Italy, Poland, Serbia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Placebo: Placebo | 204 |
| Istradefylline 20 mg/Day Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 20 mg: Istradefylline 20 mg and placebo
Placebo: Placebo | 201 |
| Istradefylline 40 mg/Day Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 40 mg: Istradefylline 40 mg and placebo
Placebo: Placebo | 207 |
| Total | 612 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 13 | 10 | 22 |
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | Did not meet entry criteria | 1 | 1 | 1 |
| Overall Study | Failed inclusion criteria | 0 | 2 | 0 |
| Overall Study | Noncompliance | 0 | 0 | 2 |
| Overall Study | Prohibited concomitant medication | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 7 | 3 |
Baseline characteristics
| Characteristic | Placebo | Istradefylline 20 mg/Day | Istradefylline 40 mg/Day | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 100 Participants | 93 Participants | 106 Participants | 299 Participants |
| Age, Categorical Between 18 and 65 years | 104 Participants | 108 Participants | 101 Participants | 313 Participants |
| Age, Continuous | 63.8 years | 63.5 years | 64.5 years | 63.9 years |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 3 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 2 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Other - did not wish to specify | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other - Filipino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other - Hispanic | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other - Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other - Indian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other - Indian/Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other - Puerto Rican | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 199 Participants | 192 Participants | 200 Participants | 591 Participants |
| Region of Enrollment Canada | 11 participants | 11 participants | 10 participants | 32 participants |
| Region of Enrollment Czechia | 22 participants | 23 participants | 23 participants | 68 participants |
| Region of Enrollment Germany | 13 participants | 15 participants | 17 participants | 45 participants |
| Region of Enrollment Israel | 11 participants | 12 participants | 12 participants | 35 participants |
| Region of Enrollment Italy | 21 participants | 18 participants | 20 participants | 59 participants |
| Region of Enrollment Poland | 24 participants | 23 participants | 23 participants | 70 participants |
| Region of Enrollment Serbia | 9 participants | 7 participants | 9 participants | 25 participants |
| Region of Enrollment United States | 93 participants | 92 participants | 92 participants | 277 participants |
| Sex: Female, Male Female | 80 Participants | 76 Participants | 81 Participants | 237 Participants |
| Sex: Female, Male Male | 124 Participants | 125 Participants | 126 Participants | 375 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 204 | 0 / 201 | 1 / 207 |
| other Total, other adverse events | 111 / 204 | 117 / 201 | 132 / 207 |
| serious Total, serious adverse events | 7 / 204 | 6 / 201 | 8 / 207 |
Outcome results
Primary
Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12
Based on the 24-hour ON/OFF patient diary data.
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Population: The number of subjects in each row is based on the number of subjects with valid diary entries for the corresponding week
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12 | Week 10 | 4.33 hours |
| Placebo | Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12 | Week 6 | 4.17 hours |
| Placebo | Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12 | Baseline | 5.17 hours |
| Placebo | Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12 | Week 2 | 4.83 hours |
| Placebo | Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12 | Week 12 | 4.17 hours |
| Istradefylline 20 mg/Day | Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12 | Week 6 | 3.83 hours |
| Istradefylline 20 mg/Day | Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12 | Baseline | 5.33 hours |
| Istradefylline 20 mg/Day | Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12 | Week 2 | 4.33 hours |
| Istradefylline 20 mg/Day | Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12 | Week 10 | 3.83 hours |
| Istradefylline 20 mg/Day | Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12 | Week 12 | 4.00 hours |
| Istradefylline 40 mg/Day | Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12 | Week 12 | 3.83 hours |
| Istradefylline 40 mg/Day | Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12 | Week 10 | 3.50 hours |
| Istradefylline 40 mg/Day | Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12 | Baseline | 4.92 hours |
| Istradefylline 40 mg/Day | Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12 | Week 6 | 3.83 hours |
| Istradefylline 40 mg/Day | Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12 | Week 2 | 4.08 hours |
Secondary
Beck Depression Inventory (BDI)
The Beck Depression Inventory is a 21-question test that measures the severity of depression. Subjects rated each on a scale of 0 to 3 for change from baseline utilizing the following scale: * 0 = I do not feel sad * 1 = I feel sad * 2 = I am sad all the time and I can't snap out of it * 3 = I am so sad or unhappy that I can't stand it The test is scored for each question using the above scale to determine the severity of depression. Scoring is as shown below: * 0 to 9: minimal depression * 10 to 18: mild depression * 19 to 29: moderate depression * 30 to 63: severe depression
Time frame: Baseline and Week 12.
Population: The number of subjects in each row is based on the number of subjects with data for the corresponding week
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Beck Depression Inventory (BDI) | Baseline | 8.8 score on a scale |
| Placebo | Beck Depression Inventory (BDI) | Week 12 | 7.9 score on a scale |
| Istradefylline 20 mg/Day | Beck Depression Inventory (BDI) | Baseline | 8.6 score on a scale |
| Istradefylline 20 mg/Day | Beck Depression Inventory (BDI) | Week 12 | 7.5 score on a scale |
| Istradefylline 40 mg/Day | Beck Depression Inventory (BDI) | Baseline | 9.3 score on a scale |
| Istradefylline 40 mg/Day | Beck Depression Inventory (BDI) | Week 12 | 8.3 score on a scale |
Secondary
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) assesses different cognitive domains, broken down as follows: Visuospatial and executive functioning: 5 points Animal Naming: 3 points Attention: 6 points Language: 3 points Abstraction: 2 points Delayed recall (short-term memory): 5 points Orientation: 6 points Scores can range from 0 to 30. A score of 26 or above is considered normal.
Time frame: Baseline and Week 12.
Population: Intent-to-Treat Analysis set: Includes all subjects randomized to a treatment arm and with both a valid baseline and at least one valid post-baseline patient diary.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Montreal Cognitive Assessment (MoCA) | Score at Baseline | 28 score on a scale |
| Placebo | Montreal Cognitive Assessment (MoCA) | Score at Week 12 | 27.8 score on a scale |
| Istradefylline 20 mg/Day | Montreal Cognitive Assessment (MoCA) | Score at Baseline | 28 score on a scale |
| Istradefylline 20 mg/Day | Montreal Cognitive Assessment (MoCA) | Score at Week 12 | 27.9 score on a scale |
| Istradefylline 40 mg/Day | Montreal Cognitive Assessment (MoCA) | Score at Baseline | 28 score on a scale |
| Istradefylline 40 mg/Day | Montreal Cognitive Assessment (MoCA) | Score at Week 12 | 27.7 score on a scale |
Secondary
Patient Global Impression - Improvement (PGI-I) Scale
The key symptom on the PGI-I was evaluated at baseline and subsequent post-baseline visits for the subject's overall condition and the symptoms of fatigue, sleep, motivation to get things done, and each subject's key symptom. Subjects rated each on a scale of 1 to 5 for change from baseline utilizing the following scale: * 1 = Moderate improvement (or greater) * 2 = Mild improvement * 3 = No change from baseline * 4 = Mild deterioration * 5 = Moderate deterioration (or greater) A lower number is a better outcome. Overall condition is presented below.
Time frame: Baseline, Week 2, Week 6, Week 10, Week 12 and 30-day FU visit
Population: The number of subjects in each row is based on the number of subjects with data for the corresponding week
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 2 | 4 = Mild deterioration | 15 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 12 | 2 = Mild improvement | 59 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 6 | 5 = Moderate deterioration (or greater) | 1 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | 30-Day Follow Up | 5 = Moderate deterioration (or greater) | 2 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 2 | 1 = Moderate improvement (or greater) | 20 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 10 | 1 = Moderate improvement (or greater) | 28 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | 30-Day Follow Up | 2 = Mild improvement | 10 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 12 | 1 = Moderate improvement (or greater) | 32 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 10 | 2 = Mild improvement | 66 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 2 | 5 = Moderate deterioration (or greater) | 3 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 10 | 5 = Moderate deterioration (or greater) | 5 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 10 | 3 = No change from baseline | 68 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | 30-Day Follow Up | 4 = Mild deterioration | 9 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 10 | 4 = Mild deterioration | 22 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | 30-Day Follow Up | 1 = Moderate improvement (or greater) | 3 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 6 | 1 = Moderate improvement (or greater) | 31 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 2 | 3 = No change from baseline | 87 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 12 | 5 = Moderate deterioration (or greater) | 5 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 6 | 2 = Mild improvement | 61 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 2 | 2 = Mild improvement | 73 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 12 | 4 = Mild deterioration | 20 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 6 | 3 = No change from baseline | 83 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | 30-Day Follow Up | 3 = No change from baseline | 22 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 12 | 3 = No change from baseline | 72 Participants |
| Placebo | Patient Global Impression - Improvement (PGI-I) Scale | Week 6 | 4 = Mild deterioration | 21 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 12 | 1 = Moderate improvement (or greater) | 38 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 2 | 1 = Moderate improvement (or greater) | 26 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 2 | 2 = Mild improvement | 80 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 2 | 3 = No change from baseline | 68 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 2 | 4 = Mild deterioration | 13 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 2 | 5 = Moderate deterioration (or greater) | 6 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 6 | 1 = Moderate improvement (or greater) | 37 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 6 | 2 = Mild improvement | 65 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 6 | 3 = No change from baseline | 63 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 6 | 4 = Mild deterioration | 19 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 6 | 5 = Moderate deterioration (or greater) | 3 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 10 | 1 = Moderate improvement (or greater) | 33 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 10 | 2 = Mild improvement | 63 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 10 | 3 = No change from baseline | 58 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 10 | 4 = Mild deterioration | 22 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 10 | 5 = Moderate deterioration (or greater) | 7 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 12 | 2 = Mild improvement | 62 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 12 | 3 = No change from baseline | 52 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 12 | 4 = Mild deterioration | 26 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 12 | 5 = Moderate deterioration (or greater) | 3 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | 30-Day Follow Up | 1 = Moderate improvement (or greater) | 1 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | 30-Day Follow Up | 2 = Mild improvement | 3 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | 30-Day Follow Up | 3 = No change from baseline | 21 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | 30-Day Follow Up | 4 = Mild deterioration | 14 Participants |
| Istradefylline 20 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | 30-Day Follow Up | 5 = Moderate deterioration (or greater) | 12 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 12 | 2 = Mild improvement | 60 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 6 | 3 = No change from baseline | 66 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 2 | 1 = Moderate improvement (or greater) | 20 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 12 | 3 = No change from baseline | 59 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 6 | 2 = Mild improvement | 56 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | 30-Day Follow Up | 3 = No change from baseline | 28 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 12 | 4 = Mild deterioration | 23 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 6 | 1 = Moderate improvement (or greater) | 35 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 2 | 2 = Mild improvement | 68 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 12 | 5 = Moderate deterioration (or greater) | 6 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 2 | 5 = Moderate deterioration (or greater) | 2 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | 30-Day Follow Up | 5 = Moderate deterioration (or greater) | 2 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | 30-Day Follow Up | 1 = Moderate improvement (or greater) | 3 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 2 | 4 = Mild deterioration | 15 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 10 | 3 = No change from baseline | 65 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | 30-Day Follow Up | 4 = Mild deterioration | 16 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 10 | 4 = Mild deterioration | 24 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 10 | 2 = Mild improvement | 57 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | 30-Day Follow Up | 2 = Mild improvement | 7 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 10 | 5 = Moderate deterioration (or greater) | 5 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 10 | 1 = Moderate improvement (or greater) | 32 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 6 | 5 = Moderate deterioration (or greater) | 3 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 12 | 1 = Moderate improvement (or greater) | 29 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 6 | 4 = Mild deterioration | 37 Participants |
| Istradefylline 40 mg/Day | Patient Global Impression - Improvement (PGI-I) Scale | Week 2 | 3 = No change from baseline | 94 Participants |
Secondary
Percentage of Awake Time Per Day Spent in the OFF State
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Population: The number of subjects in each row is based on the number of subjects with valid diary entries for the corresponding week
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Percentage of Awake Time Per Day Spent in the OFF State | Baseline | 34.55 percentage of hours |
| Placebo | Percentage of Awake Time Per Day Spent in the OFF State | Week 6 | 28.04 percentage of hours |
| Placebo | Percentage of Awake Time Per Day Spent in the OFF State | Week 10 | 28.80 percentage of hours |
| Placebo | Percentage of Awake Time Per Day Spent in the OFF State | Week 12 | 28.62 percentage of hours |
| Placebo | Percentage of Awake Time Per Day Spent in the OFF State | Week 2 | 30.95 percentage of hours |
| Istradefylline 20 mg/Day | Percentage of Awake Time Per Day Spent in the OFF State | Week 12 | 26.24 percentage of hours |
| Istradefylline 20 mg/Day | Percentage of Awake Time Per Day Spent in the OFF State | Week 10 | 25.69 percentage of hours |
| Istradefylline 20 mg/Day | Percentage of Awake Time Per Day Spent in the OFF State | Week 2 | 29.46 percentage of hours |
| Istradefylline 20 mg/Day | Percentage of Awake Time Per Day Spent in the OFF State | Baseline | 33.92 percentage of hours |
| Istradefylline 20 mg/Day | Percentage of Awake Time Per Day Spent in the OFF State | Week 6 | 26.31 percentage of hours |
| Istradefylline 40 mg/Day | Percentage of Awake Time Per Day Spent in the OFF State | Baseline | 33.16 percentage of hours |
| Istradefylline 40 mg/Day | Percentage of Awake Time Per Day Spent in the OFF State | Week 6 | 26.39 percentage of hours |
| Istradefylline 40 mg/Day | Percentage of Awake Time Per Day Spent in the OFF State | Week 12 | 26.51 percentage of hours |
| Istradefylline 40 mg/Day | Percentage of Awake Time Per Day Spent in the OFF State | Week 2 | 27.45 percentage of hours |
| Istradefylline 40 mg/Day | Percentage of Awake Time Per Day Spent in the OFF State | Week 10 | 25.09 percentage of hours |
Secondary
Percentage of ON Time Per Day Without Troublesome Dyskinesia.
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Population: The number of subjects in each row is based on the number of subjects with valid diary entries for the corresponding week
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Percentage of ON Time Per Day Without Troublesome Dyskinesia. | Week 10 | 65.33 percentage of hours |
| Placebo | Percentage of ON Time Per Day Without Troublesome Dyskinesia. | Week 6 | 65.34 percentage of hours |
| Placebo | Percentage of ON Time Per Day Without Troublesome Dyskinesia. | Week 12 | 65.17 percentage of hours |
| Placebo | Percentage of ON Time Per Day Without Troublesome Dyskinesia. | Week 2 | 62.99 percentage of hours |
| Placebo | Percentage of ON Time Per Day Without Troublesome Dyskinesia. | Baseline | 58.54 percentage of hours |
| Istradefylline 20 mg/Day | Percentage of ON Time Per Day Without Troublesome Dyskinesia. | Baseline | 61.04 percentage of hours |
| Istradefylline 20 mg/Day | Percentage of ON Time Per Day Without Troublesome Dyskinesia. | Week 2 | 64.72 percentage of hours |
| Istradefylline 20 mg/Day | Percentage of ON Time Per Day Without Troublesome Dyskinesia. | Week 6 | 68.51 percentage of hours |
| Istradefylline 20 mg/Day | Percentage of ON Time Per Day Without Troublesome Dyskinesia. | Week 10 | 68.65 percentage of hours |
| Istradefylline 20 mg/Day | Percentage of ON Time Per Day Without Troublesome Dyskinesia. | Week 12 | 68.17 percentage of hours |
| Istradefylline 40 mg/Day | Percentage of ON Time Per Day Without Troublesome Dyskinesia. | Week 12 | 67.64 percentage of hours |
| Istradefylline 40 mg/Day | Percentage of ON Time Per Day Without Troublesome Dyskinesia. | Week 10 | 68.17 percentage of hours |
| Istradefylline 40 mg/Day | Percentage of ON Time Per Day Without Troublesome Dyskinesia. | Baseline | 61.54 percentage of hours |
| Istradefylline 40 mg/Day | Percentage of ON Time Per Day Without Troublesome Dyskinesia. | Week 6 | 67.55 percentage of hours |
| Istradefylline 40 mg/Day | Percentage of ON Time Per Day Without Troublesome Dyskinesia. | Week 2 | 66.26 percentage of hours |
Secondary
Sleep Time in Hours Per Day Based Upon 24-hour Diaries.
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Population: The number of subjects in each row is based on the number of subjects with valid diary entries for the corresponding week
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Sleep Time in Hours Per Day Based Upon 24-hour Diaries. | Week 10 | 8.38 hours |
| Placebo | Sleep Time in Hours Per Day Based Upon 24-hour Diaries. | Week 6 | 8.23 hours |
| Placebo | Sleep Time in Hours Per Day Based Upon 24-hour Diaries. | Baseline | 8.11 hours |
| Placebo | Sleep Time in Hours Per Day Based Upon 24-hour Diaries. | Week 2 | 8.10 hours |
| Placebo | Sleep Time in Hours Per Day Based Upon 24-hour Diaries. | Week 12 | 8.26 hours |
| Istradefylline 20 mg/Day | Sleep Time in Hours Per Day Based Upon 24-hour Diaries. | Week 6 | 8.21 hours |
| Istradefylline 20 mg/Day | Sleep Time in Hours Per Day Based Upon 24-hour Diaries. | Baseline | 8.04 hours |
| Istradefylline 20 mg/Day | Sleep Time in Hours Per Day Based Upon 24-hour Diaries. | Week 2 | 8.14 hours |
| Istradefylline 20 mg/Day | Sleep Time in Hours Per Day Based Upon 24-hour Diaries. | Week 10 | 8.30 hours |
| Istradefylline 20 mg/Day | Sleep Time in Hours Per Day Based Upon 24-hour Diaries. | Week 12 | 8.13 hours |
| Istradefylline 40 mg/Day | Sleep Time in Hours Per Day Based Upon 24-hour Diaries. | Week 12 | 8.30 hours |
| Istradefylline 40 mg/Day | Sleep Time in Hours Per Day Based Upon 24-hour Diaries. | Week 10 | 8.44 hours |
| Istradefylline 40 mg/Day | Sleep Time in Hours Per Day Based Upon 24-hour Diaries. | Baseline | 8.11 hours |
| Istradefylline 40 mg/Day | Sleep Time in Hours Per Day Based Upon 24-hour Diaries. | Week 6 | 8.40 hours |
| Istradefylline 40 mg/Day | Sleep Time in Hours Per Day Based Upon 24-hour Diaries. | Week 2 | 8.13 hours |
Secondary
Total Hours of ON Time Per Day Without Troublesome Dyskinesia
Based on Patient's ON/OFF Diary
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Population: The number of subjects in each row is based on the number of subjects with valid diary entries for the corresponding week
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Total Hours of ON Time Per Day Without Troublesome Dyskinesia | Week 10 | 10.12 hours |
| Placebo | Total Hours of ON Time Per Day Without Troublesome Dyskinesia | Week 6 | 10.18 hours |
| Placebo | Total Hours of ON Time Per Day Without Troublesome Dyskinesia | Baseline | 9.22 hours |
| Placebo | Total Hours of ON Time Per Day Without Troublesome Dyskinesia | Week 2 | 9.89 hours |
| Placebo | Total Hours of ON Time Per Day Without Troublesome Dyskinesia | Week 12 | 10.13 hours |
| Istradefylline 20 mg/Day | Total Hours of ON Time Per Day Without Troublesome Dyskinesia | Week 6 | 10.74 hours |
| Istradefylline 20 mg/Day | Total Hours of ON Time Per Day Without Troublesome Dyskinesia | Baseline | 9.68 hours |
| Istradefylline 20 mg/Day | Total Hours of ON Time Per Day Without Troublesome Dyskinesia | Week 2 | 10.20 hours |
| Istradefylline 20 mg/Day | Total Hours of ON Time Per Day Without Troublesome Dyskinesia | Week 10 | 10.68 hours |
| Istradefylline 20 mg/Day | Total Hours of ON Time Per Day Without Troublesome Dyskinesia | Week 12 | 10.71 hours |
| Istradefylline 40 mg/Day | Total Hours of ON Time Per Day Without Troublesome Dyskinesia | Week 12 | 10.53 hours |
| Istradefylline 40 mg/Day | Total Hours of ON Time Per Day Without Troublesome Dyskinesia | Week 10 | 10.53 hours |
| Istradefylline 40 mg/Day | Total Hours of ON Time Per Day Without Troublesome Dyskinesia | Baseline | 9.72 hours |
| Istradefylline 40 mg/Day | Total Hours of ON Time Per Day Without Troublesome Dyskinesia | Week 6 | 10.46 hours |
| Istradefylline 40 mg/Day | Total Hours of ON Time Per Day Without Troublesome Dyskinesia | Week 2 | 10.46 hours |
Secondary
Total UPDRS (Parts I + II + III);
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total possible score range for all parts combined is 0 to 136. The lower the score, the more favorable the response.
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Population: The number of subjects in each row is based on the number of subjects with data for the corresponding week
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Total UPDRS (Parts I + II + III); | Week 10 | 31.6 score on a scale |
| Placebo | Total UPDRS (Parts I + II + III); | Week 6 | 32.4 score on a scale |
| Placebo | Total UPDRS (Parts I + II + III); | Baseline | 35.9 score on a scale |
| Placebo | Total UPDRS (Parts I + II + III); | Week 2 | 32.6 score on a scale |
| Placebo | Total UPDRS (Parts I + II + III); | Week 12 | 31.9 score on a scale |
| Istradefylline 20 mg/Day | Total UPDRS (Parts I + II + III); | Week 6 | 31.9 score on a scale |
| Istradefylline 20 mg/Day | Total UPDRS (Parts I + II + III); | Baseline | 35.9 score on a scale |
| Istradefylline 20 mg/Day | Total UPDRS (Parts I + II + III); | Week 2 | 32.7 score on a scale |
| Istradefylline 20 mg/Day | Total UPDRS (Parts I + II + III); | Week 10 | 31.6 score on a scale |
| Istradefylline 20 mg/Day | Total UPDRS (Parts I + II + III); | Week 12 | 31.9 score on a scale |
| Istradefylline 40 mg/Day | Total UPDRS (Parts I + II + III); | Week 12 | 32.9 score on a scale |
| Istradefylline 40 mg/Day | Total UPDRS (Parts I + II + III); | Week 10 | 33.0 score on a scale |
| Istradefylline 40 mg/Day | Total UPDRS (Parts I + II + III); | Baseline | 38.3 score on a scale |
| Istradefylline 40 mg/Day | Total UPDRS (Parts I + II + III); | Week 6 | 33.5 score on a scale |
| Istradefylline 40 mg/Day | Total UPDRS (Parts I + II + III); | Week 2 | 33.6 score on a scale |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II)
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part II is a self-evaluation of the activities of daily life (ADL) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part II is 0 to 52. The lower the score, the more favorable the response.
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Population: The number of subjects in each row is based on the number of subjects with data for the corresponding week
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II) | Week 10 | 10.9 score on a scale |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II) | Week 6 | 11.0 score on a scale |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II) | Baseline | 12.2 score on a scale |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II) | Week 2 | 11.1 score on a scale |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II) | Week 12 | 10.9 score on a scale |
| Istradefylline 20 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II) | Week 6 | 10.5 score on a scale |
| Istradefylline 20 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II) | Baseline | 12.0 score on a scale |
| Istradefylline 20 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II) | Week 2 | 10.7 score on a scale |
| Istradefylline 20 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II) | Week 10 | 10.8 score on a scale |
| Istradefylline 20 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II) | Week 12 | 10.7 score on a scale |
| Istradefylline 40 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II) | Week 12 | 11.8 score on a scale |
| Istradefylline 40 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II) | Week 10 | 11.6 score on a scale |
| Istradefylline 40 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II) | Baseline | 13.1 score on a scale |
| Istradefylline 40 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II) | Week 6 | 11.8 score on a scale |
| Istradefylline 40 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II) | Week 2 | 11.5 score on a scale |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I)
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part I is the evaluation of mentation, behavior, and mood with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part I is 0 to 16. The lower the score, the more favorable the response.
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Population: The number of subjects in each row is based on the number of subjects with data for the corresponding week
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I) | Week 10 | 1.5 score on a scale |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I) | Week 6 | 1.5 score on a scale |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I) | Baseline | 1.8 score on a scale |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I) | Week 2 | 1.4 score on a scale |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I) | Week 12 | 1.5 score on a scale |
| Istradefylline 20 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I) | Week 6 | 1.3 score on a scale |
| Istradefylline 20 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I) | Baseline | 1.3 score on a scale |
| Istradefylline 20 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I) | Week 2 | 1.1 score on a scale |
| Istradefylline 20 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I) | Week 10 | 1.4 score on a scale |
| Istradefylline 20 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I) | Week 12 | 1.4 score on a scale |
| Istradefylline 40 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I) | Week 12 | 1.4 score on a scale |
| Istradefylline 40 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I) | Week 10 | 1.4 score on a scale |
| Istradefylline 40 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I) | Baseline | 1.7 score on a scale |
| Istradefylline 40 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I) | Week 6 | 1.5 score on a scale |
| Istradefylline 40 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I) | Week 2 | 1.3 score on a scale |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III);
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part III assesses the motor signs of Parkinson's Disease with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part III is 0 to 68. The lower the score, the more favorable the response.
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Population: The number of subjects in each row is based on the number of subjects with data for the corresponding week
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III); | Week 10 | 19.2 score on a scale |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III); | Week 6 | 19.9 score on a scale |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III); | Baseline | 22 score on a scale |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III); | Week 2 | 20.1 score on a scale |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III); | Week 12 | 19.4 score on a scale |
| Istradefylline 20 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III); | Week 6 | 20.2 score on a scale |
| Istradefylline 20 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III); | Baseline | 22.6 score on a scale |
| Istradefylline 20 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III); | Week 2 | 20.8 score on a scale |
| Istradefylline 20 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III); | Week 10 | 19.4 score on a scale |
| Istradefylline 20 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III); | Week 12 | 19.7 score on a scale |
| Istradefylline 40 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III); | Week 12 | 19.6 score on a scale |
| Istradefylline 40 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III); | Week 10 | 19.9 score on a scale |
| Istradefylline 40 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III); | Baseline | 23.5 score on a scale |
| Istradefylline 40 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III); | Week 6 | 20.2 score on a scale |
| Istradefylline 40 mg/Day | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III); | Week 2 | 20.7 score on a scale |