Phase 3
Completed N=613
A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
Source: ClinicalTrials.gov NCT01968031 ↗Enrolled (actual)
613
Serious AEs
3.4%
Results posted
Nov 2020
Primary outcomePrimary: Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12 — 5.17; 5.33; 4.92; 4.83 hours
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12 |
5.17; 5.33; 4.92; 4.83; 4.33; 4.08 | — |
| SECONDARY Total Hours of ON Time Per Day Without Troublesome Dyskinesia |
9.22; 9.68; 9.72; 9.89; 10.20; 10.46 | — |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III); |
22; 22.6; 23.5; 20.1; 20.8; 20.7 | — |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II) |
12.2; 12.0; 13.1; 11.1; 10.7; 11.5 | — |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I) |
1.8; 1.3; 1.7; 1.4; 1.1; 1.3 | — |
| SECONDARY Total UPDRS (Parts I + II + III); |
35.9; 35.9; 38.3; 32.6; 32.7; 33.6 | — |
| SECONDARY Patient Global Impression - Improvement (PGI-I) Scale |
20; 26; 20; 73; 80; 68 | — |
| SECONDARY Sleep Time in Hours Per Day Based Upon 24-hour Diaries. |
8.11; 8.04; 8.11; 8.10; 8.14; 8.13 | — |
| SECONDARY Percentage of Awake Time Per Day Spent in the OFF State |
34.55; 33.92; 33.16; 30.95; 29.46; 27.45 | — |
| SECONDARY Percentage of ON Time Per Day Without Troublesome Dyskinesia. |
58.54; 61.04; 61.54; 62.99; 64.72; 66.26 | — |
| SECONDARY Montreal Cognitive Assessment (MoCA) |
28; 28; 28; 27.8; 27.9; 27.7 | — |
| SECONDARY Beck Depression Inventory (BDI) |
8.8; 8.6; 9.3; 7.9; 7.5; 8.3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01968031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.