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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT00955526
First received: August 7, 2009
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: Istradefylline
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Placebo-Controlled, Double-Blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • Reducing the mean total hours of awake time per day spent in the OFF state [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reducing the mean percentage of awake time per day spent in the OFF state [ Designated as safety issue: No ]
  • 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) [ Designated as safety issue: No ]
  • Change in Unified Parkinson's Disease Rating Scale (UPDRS) [ Designated as safety issue: No ]
  • Change in the Clinical Global Impression - Improvement scale (CGI-I) [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]

Enrollment: 373
Study Start Date: July 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Istradefylline 20mg Drug: Istradefylline
20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks)
Other Name: KW-6002
Experimental: Istradefylline 40mg Drug: Istradefylline
40mg KW-6002 per day (two 20 mg tablets orally once daily for 12 weeks)
Other Name: KW-6002
Placebo Comparator: Placebo Drug: Placebo
Two placebo tablets once daily for 12 weeks

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955526

Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
Investigators
Study Director: Study Director Kyowa Hakko Kirin Co., Ltd.
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT00955526     History of Changes
Other Study ID Numbers: 6002-009
Study First Received: August 7, 2009
Last Updated: August 28, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyowa Hakko Kirin Company, Limited:
Parkinson's disease
levodopa
end of dose wearing off
OFF time

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Istradefylline
Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014