NCT00957203

Brief Summary

Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are eligible to enter into this long-term study. The purpose of this study is to evaluate the safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's disease treated with levodopa.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

August 31, 2012

Status Verified

August 1, 2012

Enrollment Period

1.9 years

First QC Date

August 7, 2009

Last Update Submit

August 30, 2012

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaselevodopaend of dose wearing offOFF time

Outcome Measures

Primary Outcomes (1)

  • Adverse events

Secondary Outcomes (5)

  • Reducing the mean total hours of awake time per day spent in the OFF state

  • Reducing the mean percentage of awake time per day spent in the OFF state

  • Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia)

  • Change in Unified Parkinson's Disease Rating Scale (UPDRS)

  • Change in the Clinical Global Impression - Improvement scale (CGI-I)

Study Arms (1)

Istradefylline

EXPERIMENTAL
Drug: Istradefylline

Interventions

IstradefyllineDRUG

Oral istradefylline (KW-6002) 20 or 40 mg once daily

Also known as: KW-6002
Istradefylline

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be willing and able to give written informed consent
  • Completion of the study 6002-009

You may not qualify if:

  • Mini-mental status examination score of 23 or less
  • Less than 70% of compliance in the study 6002-009
  • Emergency deviation in the study 6002-009
  • Pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

istradefylline

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Study Director

    Kyowa Kirin Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2009

First Posted

August 12, 2009

Study Start

October 1, 2009

Primary Completion

September 1, 2011

Study Completion

March 1, 2012

Last Updated

August 31, 2012

Record last verified: 2012-08

Locations

JP(1)