NCT00199433

Brief Summary

The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40 mg per day of istradefylline (KW6002) as monotherapy in patients with Parkinson's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2005

Shorter than P25 for phase_2

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

May 1, 2005

Completed
4 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
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

September 12, 2005

Last Update Submit

April 23, 2024

Conditions

Parkinson's DiseaseMovement Disorder Syndrome

Keywords

Parkinson's DiseaseMovement DisorderNeurology,Clinical Trial

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the UPDRS subscale III at endpoint.

Secondary Outcomes (7)

  • Interim actual and change from baseline values in UPDRS total and subscale scores, Clinical Global Impression, measures of motor performance, and neuropsychological testing.

  • Safety:

  • Exam

  • vitals

  • weight

  • +2 more secondary outcomes

Interventions

Istradefylline (KW-6002)DRUG

Eligibility Criteria

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

You may qualify if:

  • Early PD by UKPDS criteria
  • Mild to moderate difficulty daily activities
  • Females: Either postmenopausal or willing to use adequate contraception

You may not qualify if:

  • Unable to discontinue current PD medication
  • Exposure to Levodopa for more than 1 month
  • Symptoms that may suggest a diagnosis other than Parkinson's disease
  • Medical conditions and/or abnormal laboratory findings which preclude participation including cancer in the last 5 years, a history of drug abuse/dependence, abnormal cognitive status, a history of seizures, neuroleptic malignant syndrome, psychosis, or abnormal liver function tests

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 DiseaseMovement Disorders

Interventions

istradefylline

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Neil Sussman, MD

    Kyowa Kirin, Inc.

    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

May 1, 2005

Primary Completion

July 1, 2006

Study Completion

August 1, 2006

Last Updated

April 25, 2024

Record last verified: 2024-04

Locations

US(1)