NCT00199368

Brief Summary

This is a 1-year, open-label, long-term safety extension for patients who have completed prior istradefylline studies 6002-EU-007, 6002-US-013 or 6002-US-018.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,100

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2004

Typical duration for phase_3

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

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

2.4 years

First QC Date

September 12, 2005

Last Update Submit

April 23, 2024

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaselevodopaend of dose wearing offOFF time

Outcome Measures

Primary Outcomes (1)

  • Safety

Secondary Outcomes (1)

  • Safety

Interventions

Istradefylline ( KW-6002)DRUG

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completion of study 6002-EU-007, 6002-US-013 or 6002-US-018
  • Non-pregnant and either not of childbearing potential or using specified contraception

You may not qualify if:

  • History of psychotic illness
  • Variant/atypical Parkinson's disease
  • Cancer within 5 years of enrollment
  • ALT/AST levels \> 1.5 times ULN
  • Seizure disorder
  • Neuroleptic malignant syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyowa Pharmaceutical Inc.

Princeton, New Jersey, 08540, United States

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

  • Neil Sussman, MD

    Kyowa Kirin, Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

October 1, 2004

Primary Completion

March 1, 2007

Study Completion

May 1, 2007

Last Updated

April 25, 2024

Record last verified: 2024-04

Locations

US(1)