A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients

This study has been completed.
Sponsor:
Information provided by:
Kyowa Kirin Pharmaceutical Development, Inc.
ClinicalTrials.gov Identifier:
NCT00199433
First received: September 12, 2005
Last updated: July 12, 2016
Last verified: July 2016
  Purpose
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40 mg per day of istradefylline (KW6002) as monotherapy in patients with Parkinson's disease.

Condition Intervention Phase
Parkinson's Disease
Movement Disorder Syndrome
Drug: Istradefylline (KW-6002)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase 2, Double-blind, Placebo-controlled, Randomized, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of 40mg/Day KW-6002 (Istradefylline) as Monotherapy in Subjects With Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Kyowa Kirin Pharmaceutical Development, Inc.:

Primary Outcome Measures:
  • Change from baseline in the UPDRS subscale III at endpoint.

Secondary Outcome Measures:
  • Interim actual and change from baseline values in UPDRS total and subscale scores, Clinical Global Impression, measures of motor performance, and neuropsychological testing.
  • Safety:
  • Exam
  • vitals
  • weight
  • ECG
  • laboratory tests and adverse events

Estimated Enrollment: 160
Study Start Date: May 2005
Study Completion Date: August 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Parkinson's disease is a progressive disease which results in deterioration of motor function and is the result of dopamine depletion in specific brain structures. Current therapeutic approaches include dopamine replacement and the use of dopamine receptor agonist drugs. These therapies are effective but may be associated with unwanted complications like wearing off phenomena and involuntary abnormal movements (dyskinesia). Istradefylline may provide a nondopaminergic approach to the treatment of Parkinson's disease.

This study will compare the efficacy of 40 mg per day of istradefylline in improving the symptoms of Parkinson's disease with placebo.

  Eligibility

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Early PD by UKPDS criteria
  2. Mild to moderate difficulty daily activities
  3. Females: Either postmenopausal or willing to use adequate contraception

Exclusion Criteria:

  1. Unable to discontinue current PD medication
  2. Exposure to Levodopa for more than 1 month
  3. Symptoms that may suggest a diagnosis other than Parkinson's disease
  4. Medical conditions and/or abnormal laboratory findings which preclude participation including cancer in the last 5 years, a history of drug abuse/dependence, abnormal cognitive status, a history of seizures, neuroleptic malignant syndrome, psychosis, or abnormal liver function tests
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199433

Locations
United States, New Jersey
Kyowa Pharmaceutical Inc.
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Kyowa Kirin Pharmaceutical Development, Inc.
Investigators
Study Director: Neil Sussman, MD Kyowa Kirin Pharmaceutical Development, Inc.
  More Information

ClinicalTrials.gov Identifier: NCT00199433     History of Changes
Other Study ID Numbers: 6002-US-051 
Study First Received: September 12, 2005
Last Updated: July 12, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Kyowa Kirin Pharmaceutical Development, Inc.:
Parkinson's Disease
Movement Disorder
Neurology,
Clinical Trial

Additional relevant MeSH terms:
Parkinson Disease
Movement Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Istradefylline
Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2016