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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
613
Istradefylline 40 mg and placebo
Istradefylline 20 mg and placebo
Placebo
Kyowa PD Site
Phoenix, Arizona, United States
Kyowa PD Site
Sun City, Arizona, United States
Kyowa PD Site
Tucson, Arizona, United States
Kyowa PD Site
Fountain Valley, California, United States
Kyowa PD Site
Irvine, California, United States
Kyowa PD Site
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.
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.
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.
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.
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.
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.
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
Sleep Time in Hours Per Day Based Upon 24-hour Diaries.
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Percentage of Awake Time Per Day Spent in the OFF State
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Percentage of ON Time Per Day Without Troublesome Dyskinesia.
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
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.
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.
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