12-Week, Double-Blind, Placeob-Controlled Study of 20 and 60 mg/Day Istradefylline in Parkinson's Disease Patients on Levodopa/Carbodopa

This study has been completed.
Sponsor:
Information provided by:
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00456794
First received: April 3, 2007
Last updated: June 22, 2010
Last verified: April 2007

April 3, 2007
June 22, 2010
March 2002
Not Provided
Change from Baseline to Endpoint in percentage of awake time per day in an OFF state based on the subjects' valid ON/OFF Parkinson's disease diary data.
Change from Baseline to Endpoint in percentage of awake time per day in an OFF state based on the subjects’ valid ON/OFF Parkinson's disease diary data.
Complete list of historical versions of study NCT00456794 on ClinicalTrials.gov Archive Site
Actual values and mean change from Baseline in percentage and total hours of awake time per day in the OFF state and ON state, UPDRS I-IV, II and III Scores during ON and OFF states, Global Clinical Impression-Improvement (CGI-I), safety
Same as current
Not Provided
Not Provided
 
12-Week, Double-Blind, Placeob-Controlled Study of 20 and 60 mg/Day Istradefylline in Parkinson's Disease Patients on Levodopa/Carbodopa
A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of Doses of 20 and 60 mg/Day Istradefylline as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa

A 12-week, multicenter, double-blind, randomized study designed to evaluate the safety and efficacy of 20 and 60 mg/day istradefylline compared with placebo in subjects with OFF-time phenomena and advanced Parkinson's disease treated with levodopa/carbidopa.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Parkinson's Disease
Drug: Istradefylline (KW-6002)
Not Provided
Stacy M, Silver D, Mendis T, Sutton J, Mori A, Chaikin P, Sussman NM. A 12-week, placebo-controlled study (6002-US-006) of istradefylline in Parkinson disease. Neurology. 2008 Jun 3;70(23):2233-40.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
325
October 2003
Not Provided

Inclusion Criteria:

  1. United Kingdom Parkinson's Disease Society brain bank diagnostic criteria (Steps 1 and 2).
  2. Modified Hoehn and Yahr in the OFF state of II-IV.
  3. Treated with levodopa/carbidopa for at least one year with a stable regimen for 4 weeks prior to randomization.
  4. Taking at least 4 doses of levodopa/carbidopa per day (3 doses if at least 2 doses contained slow-release formuation) with predictable end of dose wearing off.
  5. Successfully competed Parkinson's disease patient diary training with at least 120 minutes of OFF time per day.
  6. Stable regimen of other antiparkinson's medications for 4 weeks prior to randomization.
  7. At least 30 years of age and able to give written informed consent.

Exclusion Criteria:

  1. Treatment with liquid levodopa/carbidopa within 4 weeks of randomization.
  2. Treatment with MAO inhibitors except selegiline.
  3. Treatment within 3 months with centrally acting dopamine antagonists (6 months for depot formuations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine.
  4. Neurosurgical operation for Parkinson's disease.
  5. Atypical parkinsonism or secondary parkinsonism variants.
  6. Diagnosis of cancer or evidence of continued disease within 5 years.
  7. Clinically significant illness of any organ system (e.g., ALT or AST > 1.5 times the upper limit of normal).
  8. Mini-Mental Status Examination score of 25 or less.
  9. History of drug or alcohol abuse or dependence within 2 years.
  10. History of psychotic illness or seizures.
  11. Clinically relevant depression disorder.
  12. History of neuroleptic malignant syndrome.
  13. Pregnancy or lactation. Women of child bearing potential must use a reliable method of contraception.
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00456794
6002-US-006
No
Not Provided
Kyowa Hakko Kirin Pharma, Inc.
Not Provided
Study Director: Neil Sussman, MD Kyowa Hakko Kirin Pharma, Inc.
Kyowa Hakko Kirin Pharma, Inc.
April 2007

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