Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

Phase 3

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Placebo; Drug: Istradefylline

• Registration Number: NCT00955526
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40 mg/day istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-07
• Study First Submitted QC: 2009-08-07
• Study First Posted: 2009-08-10
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-28
• Last Update Posted: 2012-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

Inclusion Criteria

1. Be willing and able to give written informed consent
2. UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD
3. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale
4. On levodopa/dopa-decarboxylase inhibitor for at least one year
5. Taking at least three doses and >=300 mg of levodopa/dopa-decarboxylase inhibitor per day for at least four weeks before randomization
6. Predictable end of dose wearing off
7. Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary
8. Have an average of two hours of OFF time on 24-hour diaries
9. On a stable regimen of any other anti-Parkinson's drugs for at least four weeks before randomization
10. On a stable dose of domperidone for at least 14 days before randomization

Exclusion Criteria

1. Taking any excluded medications
2. Neurosurgical treatment or Transcranial Magnetic Stimulation for PD
3. Diagnosis of cancer within 5 years
4. Diagnosis of clinically significant illness of any organ system
5. Diagnosis of dementia or mini-mental status examination score of 23 or less
6. History of drug or alcohol abuse or dependence within the past two years
7. History of psychosis
8. History of significant drug allergies
9. Taking anticonvulsants for seizures
10. History of neuroleptic malignant syndrome
11. Pregnant or lactating females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Istradefylline 20mg	Istradefylline	-
Istradefylline 40mg	Istradefylline	-

Primary Outcome Measures

Name	Time	Method
Reducing the mean total hours of awake time per day spent in the OFF state

Secondary Outcome Measures

Name	Time	Method
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia)
Adverse events
Reducing the mean percentage of awake time per day spent in the OFF state
Change in the Clinical Global Impression - Improvement scale (CGI-I)