A Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on Levodopa

• Sponsor: Kyowa Kirin, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00199420
• Collaborator: (none)
• Enrollment: 580
• Locations: 2
• Duration (Months): 17
• Patients Per Site: 290
• Patients Per Site Per Month: 17

Study Details

Study Description

Brief Summary

To establish the efficacy of 10, 20 and 40 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: Istradefylline (KW-6002)	Phase 3

Detailed Description

To establish the efficacy of 10, 20 and 40 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 10, 20 or 40 mg or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess efficacy and safety.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of 10, 20 and 40 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy.
• Study Start Date: Jul 1, 2004
• Actual Primary Completion Date: Nov 1, 2005
• Actual Study Completion Date: Dec 1, 2005

Outcome Measures

Primary Outcome Measures

1. To establish the efficacy of 10, 20 and 40 mg/d istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/carbidopa. []

Secondary Outcome Measures

1. To evaluate the dose-response of 10, 20 and 40 mg/d istradefylline using the primary efficacy outcome variable. []

2. To evaluate the efficacy of 10, 20 and 40 mg/d istradefylline for reducing the total hours of OFF time. []

3. To evaluate the change in total hours of ON time (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia). []

4. 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). []

5. To evaluate the change in Parkinson's Disease Questionnaire (PDQ-39) and Medical Outcomes Study 36-item Short Form (SF-36). []

6. To evaluate the Patient Global Impression - Improvement scale (PGI-I). []

7. To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S). []

8. To evaluate the safety of 10, 20, and 40 mg/d istradefylline by changes in safety parameters as noted in Section 7.2.4. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyowa Pharmaceutical Inc.	Princeton	New Jersey	United States	08540
2	Kyowa Pharmaceutical	Princeton	New Jersey	United States	08540

Sponsors and Collaborators

• Kyowa Kirin, Inc.

Investigators

• Study Director: Neil Sussman, MD, Kyowa Kirin, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00199420
• Other Study ID Numbers: 6002-US-018; NCT00203983
• First Posted: Sep 20, 2005
• Last Update Posted: Jul 14, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by , ,: levodopa; end of dose wearing off; OFF time
• Additional relevant MeSH terms: Parkinson Disease; Istradefylline

Study Results

No Results Posted as of Jul 14, 2016