NCT00955526

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. Patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40 mg/day istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
373

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 7, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

August 29, 2012

Status Verified

August 1, 2012

Enrollment Period

1.6 years

First QC Date

August 7, 2009

Last Update Submit

August 28, 2012

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaselevodopaend of dose wearing offOFF time

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • 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)

  • Adverse events

Study Arms (3)

Istradefylline 20mg

EXPERIMENTAL
Drug: Istradefylline

Istradefylline 40mg

EXPERIMENTAL
Drug: Istradefylline

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

IstradefyllineDRUG

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

Also known as: KW-6002
Istradefylline 20mg
PlaceboDRUG

Two placebo tablets once daily for 12 weeks

Placebo

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
  • 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 \>=300 mg of levodopa/dopa-decarboxylase inhibitor 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
  • On a stable dose of domperidone for at least 14 days before randomization

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 23 or less
  • History of drug or alcohol abuse or dependence within the past two years
  • History of psychosis
  • History of significant drug allergies
  • Taking anticonvulsants for seizures
  • History of neuroleptic 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 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2009

First Posted

August 10, 2009

Study Start

July 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

August 29, 2012

Record last verified: 2012-08

Locations

JP(1)