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

NCT00199420 | Completed Phase 3

• 1 other identifier: 6002-US-018
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson's Disease

Keywords

levodopa; end of dose wearing off; OFF time

Outcome Measures

Primary Outcomes (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 Outcomes (8)

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

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

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

• 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).

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

Interventions

Istradefylline (KW-6002) DRUG

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.
• PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale.
• On levodopa/carbidopa for at least one year, stable dose in past 4 weeks.
• Currently take at least three doses of levodopa/carbidopa per day.
• Predictable end of dose wearing off.
• Able to satisfactorily complete Hauser version of a Parkinson's diary.
• Have an average of 180 minutes of OFF time on two 24 hour diaries.
• Be at least 30 years of age.

You may not qualify if:

• Neurosurgical treatment for PD.
• History of psychosis.
• Diagnosis of atypical parkinsonism, secondary parkinsonism variant or Parkinson's plus syndromes.
• Diagnosis of cancer within 5 years.
• Mini-mental status examination score of 25 or less.
• History of seizures or neurologic malignant\_syndrome.

Sponsors & Collaborators

• Kyowa Kirin, Inc.: lead

Study Sites (2)

Kyowa Pharmaceutical Inc.

Princeton, New Jersey, 08540, United States

Location

Kyowa Pharmaceutical

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

istradefylline

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Neil Sussman, MD

  Kyowa Kirin, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2004
• Primary Completion: November 1, 2005
• Study Completion: December 1, 2005
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

US (2)