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

NCT00199355 | Completed Phase 2

• 1 other identifier: 6002-0406
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

To establish the efficacy of 20 mg/day and 40 mg/day doses 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

Parkinson's Disease; levodopa; end of dose wearing off; OFF time

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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 change in percentage 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).

• 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).

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/DCI for at least one year, stable dose in past 4 weeks.
• Currently take at least three doses of levodopa/DCI per day.
• Predictable end of dose wearing off.
• Able to satisfactorily complete Hauser version of a Parkinson's diary.
• Have an average of 120 minutes of OFF time on two 24 hour diaries.
• On a stable regimen of medications being administered within normal therapeutic limits for Parkinson's disease for at least four weeks before randomization.
• Be at least 30 years of age.

You may not qualify if:

• Neurosurgical treatment for PD.
• History of psychosis.
• Diagnosis of atypical Parkinsonism or secondary Parkinsonism variant.
• Diagnosis of cancer within 5 years.
• Diagnosis of clinically significant illness of any organ system.
• Mini-mental status examination score of 25 or less.
• Taking any excluded medications.
• History of drug or alcohol abuse or dependence within the past two years.
• History of seizures or neurological malignant syndrome.
• Clinical depression.
• Pregnant or lactating females.

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Tokyo, Japan

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

• Study Director

  Kyowa Kirin Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: April 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: May 23, 2014

Record last verified: 2012-08

Locations

JP (1)