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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Istradefylline (KW-6002)
Sponsored by
Kyowa Kirin, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Levodopa, End of dose wearing off, OFF time

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 formulation) 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 formulations), 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.

Sites / Locations

  • Contact Kyowa Pharmaceutical, Inc.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 3, 2007
Last Updated
July 13, 2016
Sponsor
Kyowa Kirin, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00456794
Brief Title
12-Week, Double-Blind, Placebo-Controlled Study of 20 and 60 mg/Day Istradefylline in Parkinson's Disease Patients on Levodopa/Carbodopa
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kyowa Kirin, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Levodopa, End of dose wearing off, OFF time

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
325 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Istradefylline (KW-6002)
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: United Kingdom Parkinson's Disease Society brain bank diagnostic criteria (Steps 1 and 2). Modified Hoehn and Yahr in the OFF state of II-IV. Treated with levodopa/carbidopa for at least one year with a stable regimen for 4 weeks prior to randomization. Taking at least 4 doses of levodopa/carbidopa per day (3 doses if at least 2 doses contained slow-release formulation) with predictable end of dose wearing off. Successfully competed Parkinson's disease patient diary training with at least 120 minutes of OFF time per day. Stable regimen of other antiparkinson's medications for 4 weeks prior to randomization. At least 30 years of age and able to give written informed consent. Exclusion Criteria: Treatment with liquid levodopa/carbidopa within 4 weeks of randomization. Treatment with MAO inhibitors except selegiline. Treatment within 3 months with centrally acting dopamine antagonists (6 months for depot formulations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine. Neurosurgical operation for Parkinson's disease. Atypical parkinsonism or secondary parkinsonism variants. Diagnosis of cancer or evidence of continued disease within 5 years. Clinically significant illness of any organ system (e.g., ALT or AST > 1.5 times the upper limit of normal). Mini-Mental Status Examination score of 25 or less. History of drug or alcohol abuse or dependence within 2 years. History of psychotic illness or seizures. Clinically relevant depression disorder. History of neuroleptic malignant syndrome. Pregnancy or lactation. Women of child bearing potential must use a reliable method of contraception.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Sussman, MD
Organizational Affiliation
Kyowa Kirin, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Contact Kyowa Pharmaceutical, Inc.
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18519872
Citation
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. doi: 10.1212/01.wnl.0000313834.22171.17. Erratum In: Neurology. 2008 Sep16;71(12): 953.
Results Reference
derived

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

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