NCT00456794

Brief Summary

A 12-week, multicenter, double-blind, randomized study designed to evaluate the safety and efficacy of 20 and 60 mg/day istradefylline compared with placebo in subjects with OFF-time phenomena and advanced Parkinson's disease treated with levodopa/carbidopa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
325

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2002

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

March 1, 2002

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

1.6 years

First QC Date

April 3, 2007

Last Update Submit

April 23, 2024

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseLevodopaEnd of dose wearing offOFF time

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline to Endpoint in percentage of awake time per day in an OFF state based on the subjects' valid ON/OFF Parkinson's disease diary data.

Secondary Outcomes (1)

  • Actual values and mean change from Baseline in percentage and total hours of awake time per day in the OFF state and ON state, UPDRS I-IV, II and III Scores during ON and OFF states, Global Clinical Impression-Improvement (CGI-I), safety

Interventions

Istradefylline (KW-6002)DRUG

Eligibility Criteria

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

You may qualify if:

  • United Kingdom Parkinson's Disease Society brain bank diagnostic criteria (Steps 1 and 2).
  • Modified Hoehn and Yahr in the OFF state of II-IV.
  • Treated with levodopa/carbidopa for at least one year with a stable regimen for 4 weeks prior to randomization.
  • Taking at least 4 doses of levodopa/carbidopa per day (3 doses if at least 2 doses contained slow-release formulation) with predictable end of dose wearing off.
  • Successfully competed Parkinson's disease patient diary training with at least 120 minutes of OFF time per day.
  • Stable regimen of other antiparkinson's medications for 4 weeks prior to randomization.
  • At least 30 years of age and able to give written informed consent.

You may not qualify if:

  • Treatment with liquid levodopa/carbidopa within 4 weeks of randomization.
  • Treatment with MAO inhibitors except selegiline.
  • Treatment within 3 months with centrally acting dopamine antagonists (6 months for depot formulations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine.
  • Neurosurgical operation for Parkinson's disease.
  • Atypical parkinsonism or secondary parkinsonism variants.
  • Diagnosis of cancer or evidence of continued disease within 5 years.
  • Clinically significant illness of any organ system (e.g., ALT or AST \> 1.5 times the upper limit of normal).
  • Mini-Mental Status Examination score of 25 or less.
  • History of drug or alcohol abuse or dependence within 2 years.
  • History of psychotic illness or seizures.
  • Clinically relevant depression disorder.
  • History of neuroleptic malignant syndrome.
  • Pregnancy or lactation. Women of child bearing potential must use a reliable method of contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Kyowa Pharmaceutical, Inc.

Princeton, New Jersey, 08540, United States

Location

Related Publications (1)

  • Stacy M, Silver D, Mendis T, Sutton J, Mori A, Chaikin P, Sussman NM. A 12-week, placebo-controlled study (6002-US-006) of istradefylline in Parkinson disease. Neurology. 2008 Jun 3;70(23):2233-40. doi: 10.1212/01.wnl.0000313834.22171.17.

    PMID: 18519872DERIVED

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

Study Record Dates

First Submitted

April 3, 2007

First Posted

April 5, 2007

Study Start

March 1, 2002

Primary Completion

October 1, 2003

Study Completion

October 1, 2003

Last Updated

April 25, 2024

Record last verified: 2024-04

Locations

US(1)