Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00199355 |
Date of registration:
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12/09/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa
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Scientific title:
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Placebo-Controlled , Double-Blind , Exploratory Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Adjunctive Therapy to Levodopa] |
Date of first enrolment:
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April 2005 |
Target sample size:
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75 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00199355 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Japan
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Contacts
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Name:
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Study Director |
Address:
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Telephone:
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Email:
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Affiliation:
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Kyowa Hakko Kirin Company, Limited |
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Key inclusion & exclusion criteria
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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/DCI for at least one year, stable dose in past 4 weeks.
4. Currently take at least three doses of levodopa/DCI 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 120 minutes of OFF time on two 24 hour diaries.
8. On a stable regimen of medications being administered within normal therapeutic
limits for Parkinson's disease for at least four weeks before randomization.
9. Be at least 30 years of age.
Exclusion Criteria:
1. Neurosurgical treatment for PD.
2. History of psychosis.
3. Diagnosis of atypical Parkinsonism or secondary Parkinsonism variant.
4. Diagnosis of cancer within 5 years.
5. Diagnosis of clinically significant illness of any organ system.
6. Mini-mental status examination score of 25 or less.
7. Taking any excluded medications.
8. History of drug or alcohol abuse or dependence within the past two years.
9. History of seizures or neurological malignant syndrome.
10. Clinical depression.
11. Pregnant or lactating females.
Age minimum:
30 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Istradefylline (KW-6002)
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Primary Outcome(s)
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To establish the efficacy of 20 mg/d and 40mg/d doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/DCI.
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Secondary Outcome(s)
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To evaluate the change in percentage of ON time (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia).
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To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).
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To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).
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To evaluate the efficacy of 20 mg/d and 40mg/d dose of istradefylline for reducing the total hours of OFF time.
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To evaluate the safety of 20 mg/d and 40mg/d doses of istradefylline.
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To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS).
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Secondary ID(s)
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6002-0406
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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