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A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00455507
Recruitment Status : Completed
First Posted : April 3, 2007
Last Update Posted : August 29, 2012
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

Tracking Information
First Submitted Date  ICMJE April 2, 2007
First Posted Date  ICMJE April 3, 2007
Last Update Posted Date August 29, 2012
Study Start Date  ICMJE March 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2008)
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 Parkinson's disease (PD) treated with levodopa/dopa-decarboxylase inhibitor. [ Time Frame: Last Visit ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 2, 2007)
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 Parkinson's disease (PD) treated with levodopa/dopa-decarboxylase inhibitor.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2008)
  • To evaluate the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean percentage of awake time per day spent in the OFF state. [ Time Frame: Every Visit ]
  • To evaluate 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). [ Time Frame: Every Visit ]
  • To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS). [ Time Frame: Every Visit ]
  • To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I). [ Time Frame: Visit 4 and Last Visit ]
  • To evaluate the safety of 20 mg/day and 40mg/day doses of istradefylline [ Time Frame: Every Visit ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2007)
  • To evaluate the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean percentage of awake time per day spent in the OFF state.
  • To evaluate 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).
  • To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS).
  • To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).
  • To evaluate the safety of 20 mg/day and 40mg/day doses of istradefylline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa
Official Title  ICMJE Placebo-controlled, Double-blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 2 Study)
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.
Detailed Description 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 40mg/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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Drug: Istradefylline
    Two 10 mg KW-6002 tablets orally once daily for 12 weeks
    Other Name: KW-6002
  • Drug: Istradefylline
    Two 20 mg tablets orally once a day for 12 weeks
    Other Name: KW-6002
  • Drug: Placebo
    Two placebo tablets orally once daily for 12 weeks
Study Arms  ICMJE
  • Experimental: 1
    20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks)
    Intervention: Drug: Istradefylline
  • Experimental: 2
    40mg KW-6002 per day (two 20 mg KW-6002 tablets orally once daily for 12 weeks)
    Intervention: Drug: Istradefylline
  • Placebo Comparator: 3
    Two placebo tablets once daily for 12 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2008)
363
Original Enrollment  ICMJE
 (submitted: April 2, 2007)
360
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.
  2. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale.
  3. On levodopa/dopa-decarboxylase inhibitor for at least one year.
  4. Taking at least three doses and >=300mg of levodopa per day for at least four weeks before randomization.
  5. Predictable end of dose wearing off.
  6. Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary.
  7. Have an average of two hours of OFF time on 24-hour diaries.
  8. On a stable regimen of any other anti-Parkinson's drugs for at least four weeks before randomization.
  9. Be at least 20 years of age.
  10. Be willing and able to give written informed consent.

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 25 or less.
  6. History of drug or alcohol abuse or dependence within the past two years.
  7. History of psychosis.
  8. Significant drug allergies.
  9. Taking anticonvulsants for seizures.
  10. History of neurological malignant syndrome.
  11. Pregnant or lactating females.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00455507
Other Study ID Numbers  ICMJE 6002-0608
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Kyowa Kirin Co., Ltd.
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Kyowa Kirin Co., Ltd.
Original Study Sponsor  ICMJE Kyowa Hakko Kogyo Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director Kyowa Kirin Co., Ltd.
PRS Account Kyowa Kirin Co., Ltd.
Verification Date August 2012

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