Trial record 2 of 20 for:    istradefylline

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT00455507
First received: April 2, 2007
Last updated: August 28, 2012
Last verified: August 2012

April 2, 2007
August 28, 2012
March 2007
August 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00455507 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS). [ Time Frame: Every Visit ] [ Designated as safety issue: No ]
  • To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I). [ Time Frame: Visit 4 and Last Visit ] [ Designated as safety issue: No ]
  • To evaluate the safety of 20 mg/day and 40mg/day doses of istradefylline [ Time Frame: Every Visit ] [ Designated as safety issue: Yes ]
  • 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
Not Provided
Not Provided
 
A Phase 2b Study of Istradefylline (KW-6002) 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 2 Study)

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
363
August 2008
August 2008   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00455507
6002-0608
No
Kyowa Hakko Kirin Company, Limited
Kyowa Hakko Kirin Company, Limited
Not Provided
Study Director: Study Director Kyowa Hakko Kirin Company, Limited
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