A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa
NCT ID: NCT00199407
Last Updated: 2024-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
230 participants
INTERVENTIONAL
2004-06-30
2006-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Istradefylline (KW-6002)
Eligibility Criteria
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Inclusion Criteria
2. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale.
3. On levodopa/carbidopa for at least one year, stable dose in past 4 weeks.
4. Currently take at least three doses of levodopa/carbidopa per day.
5. Predictable end of dose wearing off.
6. Able to satisfactorily complete Hauser version of a Parkinson's diary.
7. Have an average of 180 minutes of OFF time on two 24 hour diaries.
8. Be at least 30 years of age.
Exclusion Criteria
2. History of psychosis.
3. Diagnosis of atypical parkinsonism, secondary parkinsonism variant or Parkinson's plus syndromes.
4. Diagnosis of cancer within 5 years.
5. Mini-mental status examination score of 25 or less.
6. History of seizures or neurologic malignant\_syndrome.
7. Clinical depression.
30 Years
ALL
No
Sponsors
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Kyowa Kirin, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Neil Sussman, MD
Role: STUDY_DIRECTOR
Kyowa Kirin, Inc.
Locations
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Kyowa Pharmaceutical Inc.
Princeton, New Jersey, United States
Countries
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Other Identifiers
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6002-US-013
Identifier Type: -
Identifier Source: org_study_id
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