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

• ClinicalTrials.gov Identifier: NCT00455507
• Recruitment Status: Completed
• First Posted: April 3, 2007
• Last Update Posted: August 29, 2012
• Sponsor: Kyowa Kirin Co., Ltd.
• Information provided by (Responsible Party): Kyowa Kirin Co., Ltd.

Tracking Information

• First Submitted Date: April 2, 2007
• First Posted Date: April 3, 2007
• Last Update Posted Date: August 29, 2012
• Study Start Date: March 2007
• Actual Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Parkinson's Disease

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 29, 2008): 363
• Original Enrollment (submitted: April 2, 2007): 360
• Actual Study Completion Date: August 2008
• Actual Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00455507
• Other Study ID Numbers: 6002-0608
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Kyowa Kirin Co., Ltd.
• Original Responsible Party: Not Provided
• Current Study Sponsor: Kyowa Kirin Co., Ltd.
• Original Study Sponsor: Kyowa Hakko Kogyo Co., Ltd.
• Collaborators: Not Provided

Investigators

• Study Director: Study Director; Kyowa Kirin Co., Ltd.

• PRS Account: Kyowa Kirin Co., Ltd.
• Verification Date: August 2012