NCT00455507

Brief Summary

The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's disease (PD) treated with levodopa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
363

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2007

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

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 29, 2012

Status Verified

August 1, 2012

Enrollment Period

1.4 years

First QC Date

April 2, 2007

Last Update Submit

August 28, 2012

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaselevodopaend of dose wearing offOFF time

Outcome Measures

Primary Outcomes (1)

  • To establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with Parkinson's disease (PD) treated with levodopa/dopa-decarboxylase inhibitor.

    Last Visit

Secondary Outcomes (5)

  • To evaluate the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean percentage of awake time per day spent in the OFF state.

    Every Visit

  • To evaluate 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).

    Every Visit

  • To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS).

    Every Visit

  • To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).

    Visit 4 and Last Visit

  • To evaluate the safety of 20 mg/day and 40mg/day doses of istradefylline

    Every Visit

Study Arms (3)

1

EXPERIMENTAL

20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks)

Drug: Istradefylline

2

EXPERIMENTAL

40mg KW-6002 per day (two 20 mg KW-6002 tablets orally once daily for 12 weeks)

Drug: Istradefylline

3

PLACEBO COMPARATOR

Two placebo tablets once daily for 12 weeks

Drug: Placebo

Interventions

IstradefyllineDRUG

Two 10 mg KW-6002 tablets orally once daily for 12 weeks

Also known as: KW-6002
1
PlaceboDRUG

Two placebo tablets orally once daily for 12 weeks

3

Eligibility Criteria

Age20 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 2-4 in the OFF state for Modified Hoehn and Yahr Scale.
  • On levodopa/dopa-decarboxylase inhibitor for at least one year.
  • Taking at least three doses and \>=300mg of levodopa per day for at least four weeks before randomization.
  • Predictable end of dose wearing off.
  • Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary.
  • Have an average of two hours of OFF time on 24-hour diaries.
  • On a stable regimen of any other anti-Parkinson's drugs for at least four weeks before randomization.
  • Be at least 20 years of age.
  • Be willing and able to give written informed consent.

You may not qualify if:

  • Taking any excluded medications.
  • Neurosurgical treatment or Transcranial Magnetic Stimulation for PD.
  • Diagnosis of cancer within 5 years.
  • Diagnosis of clinically significant illness of any organ system.
  • Diagnosis of dementia or mini-mental status examination score of 25 or less.
  • History of drug or alcohol abuse or dependence within the past two years.
  • History of psychosis.
  • Significant drug allergies.
  • Taking anticonvulsants for seizures.
  • History of neurological malignant syndrome.
  • 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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2007

First Posted

April 3, 2007

Study Start

March 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

August 29, 2012

Record last verified: 2012-08

Locations

JP(1)