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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 May 2024 |
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Main ID: |
NCT00199407 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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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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A 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of a 20 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy. |
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Date of first enrolment:
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June 2004 |
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Target sample size:
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230 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT00199407 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double.
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Neil Sussman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kyowa Kirin, Inc. |
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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/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:
1. Neurosurgical treatment for PD.
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.
Age minimum:
30 Years
Age maximum:
N/A
Gender:
All
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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 a 20 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/carbidopa.
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Secondary Outcome(s)
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To evaluate the change in the Patient Global Impression - Improvement scale (PGI-I).
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To evaluate the efficacy of a 20 mg/d dose of istradefylline for reducing the total hours of OFF time.
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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 the change in Parkinson's Disease Questionnaire (PDQ-39) and Medical Outcomes Study 36-item Short Form (SF-36).
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To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination score (part III) and/or in Activities of Daily Living (ADL) score (part II).
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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 safety of a 20 mg/d dose of istradefylline.
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Secondary ID(s)
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6002-US-013
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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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