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

August 7, 2009
August 28, 2012
July 2009
February 2011   (final data collection date for primary outcome measure)
Reducing the mean total hours of awake time per day spent in the OFF state [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00955526 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking Levodopa
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Parkinson's Disease
  • Drug: Istradefylline
    20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks)
    Other Name: KW-6002
  • Drug: Istradefylline
    40mg KW-6002 per day (two 20 mg tablets orally once daily for 12 weeks)
    Other Name: KW-6002
  • Drug: Placebo
    Two placebo tablets once daily for 12 weeks
  • Experimental: Istradefylline 20mg
    Intervention: Drug: Istradefylline
  • Experimental: Istradefylline 40mg
    Intervention: Drug: Istradefylline
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
373
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00955526
6002-009
No
Kyowa Hakko Kirin Company, Limited
Kyowa Hakko Kirin Company, Limited
Not Provided
Study Director: Study Director Kyowa Hakko Kirin Co., Ltd.
Kyowa Hakko Kirin Company, Limited
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP