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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: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00199355
Date of registration: 12/09/2005
Prospective Registration: No
Primary sponsor: Kyowa Hakko Kirin Company, Limited
Public title: A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa
Scientific title: 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: April 2005
Target sample size: 75
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00199355
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
Japan
Contacts
Name:     Study Director
Address: 
Telephone:
Email:
Affiliation:  Kyowa Hakko Kirin Company, Limited
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Parkinson's Disease
Intervention(s)
Drug: Istradefylline (KW-6002)
Primary Outcome(s)
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.
Secondary Outcome(s)
To evaluate the change in percentage of ON time (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia).
To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).
To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).
To evaluate the efficacy of 20 mg/d and 40mg/d dose of istradefylline for reducing the total hours of OFF time.
To evaluate the safety of 20 mg/d and 40mg/d doses of istradefylline.
To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS).
Secondary ID(s)
6002-0406
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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