Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking Levodopa (6002-009)

Placebo-Controlled, Double-Blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Istradefylline; Drug: Istradefylline; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 373
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Two placebo tablets once daily for 12 weeks
Experimental: Istradefylline 20mg	Drug: Istradefylline; 20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks); Other Names: KW-6002; Drug: Istradefylline; 40mg KW-6002 per day (two 20 mg tablets orally once daily for 12 weeks); Other Names: KW-6002
Experimental: Istradefylline 40mg	Drug: Istradefylline; 20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks); Other Names: KW-6002; Drug: Istradefylline; 40mg KW-6002 per day (two 20 mg tablets orally once daily for 12 weeks); Other Names: KW-6002

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reducing the mean total hours of awake time per day spent in the OFF state

Secondary Outcome Measures

Outcome Measure
Adverse events
Reducing the mean percentage of awake time per day spent in the OFF state
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)
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Change in the Clinical Global Impression - Improvement scale (CGI-I)

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: August 7, 2009
• First Submitted That Met QC Criteria: August 7, 2009
• First Posted (Estimate): August 10, 2009

Study Record Updates

• Last Update Posted (Estimate): August 29, 2012
• Last Update Submitted That Met QC Criteria: August 28, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: levodopa; Parkinson's disease; end of dose wearing off; OFF time
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Purinergic Antagonists; Purinergic Agents; Purinergic P1 Receptor Antagonists; Adenosine A2 Receptor Antagonists; Istradefylline
• Other Study ID Numbers: 6002-009