A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

Parkinson's Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199407
• Other study ID #: 6002-US-013
• Status: Completed
• Phase: Phase 3
• Start date: June 2004
• Est. completion date: January 2006

Study information

• Verified date: April 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To establish the efficacy of a 20 mg/day dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.

Description:

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. Patients who meet entry criteria will be randomized in a 1 to 1 ratio to either istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline as compared to placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: January 2006
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Istradefylline (KW-6002)

Locations

Country	Name	City	State
United States	Kyowa Pharmaceutical Inc.	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	To evaluate the efficacy of a 20 mg/d dose of istradefylline for reducing the total hours of OFF time.
Secondary	To evaluate the change in percentage of ON time (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia).
Secondary	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).
Secondary	To evaluate the change in Parkinson's Disease Questionnaire (PDQ-39) and Medical Outcomes Study 36-item Short Form (SF-36).
Secondary	To evaluate the change in the Patient Global Impression - Improvement scale (PGI-I).
Secondary	To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).
Secondary	To evaluate the safety of a 20 mg/d dose of istradefylline.