12-Week, Double-Blind, Placebo-Controlled Study of 20 and 60 mg/Day Istradefylline in Parkinson's Disease Patients on Levodopa/Carbodopa

April 23, 2024 updated by: Kyowa Kirin, Inc.

A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of Doses of 20 and 60 mg/Day Istradefylline as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

325

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Contact Kyowa Pharmaceutical, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin, Inc.

Investigators

  • Study Director: Neil Sussman, MD, Kyowa Kirin, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

October 1, 2003

Study Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

April 3, 2007

First Submitted That Met QC Criteria

April 3, 2007

First Posted (Estimated)

April 5, 2007

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6002-US-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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