NCT00250393

Brief Summary

To establish the efficacy of 40 mg/day doses of istradefylline for the change in Unified Parkinson's Disease Rating Scale (UPDRS) part-III (Motor examination) score in patients with Parkinson's disease (PD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

August 29, 2012

Status Verified

August 1, 2012

Enrollment Period

11 months

First QC Date

November 4, 2005

Last Update Submit

August 28, 2012

Conditions

Parkinson's Disease

Keywords

Parkinson's diseasemonotherapy

Outcome Measures

Primary Outcomes (1)

  • To establish the efficacy of 40mg/d doses of istradefylline for the change in UPDRS part-III (Motor examination) score in patients with Parkinson's disease (PD).

Secondary Outcomes (4)

  • To evaluate the efficacy of 40mg/d dose of istradefylline for the change in UPDRS part-I (Mentation, behavior and mood), part-II (Activities of daily living) score and UPDRS total (parts I-III) score.

  • 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).

  • To evaluate the safety of 40mg/d doses of istradefylline.

Interventions

Istradefylline (KW-6002)DRUG

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 1-3 for Modified Hoehn and Yahr Scale.
  • Be at least 30 years of age.

You may not qualify if:

  • Neurosurgical treatment for PD.
  • History of psychosis.
  • 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.

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 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2005

First Posted

November 8, 2005

Study Start

November 1, 2005

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

August 29, 2012

Record last verified: 2012-08

Locations

JP(1)