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NCT Number: NCT00199433

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorder Syndrome Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kyowa Pharmaceutical Inc.

Princeton, New Jersey, 08540, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unable to discontinue current PD medication
  • Exposure to Levodopa for more than 1 month
  • Symptoms that may suggest a diagnosis other than Parkinson's disease
  • 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

Treatment and study plan

Istradefylline (KW-6002)

Drug

Primary outcomes

  1. Change from baseline in the UPDRS subscale III at endpoint.

Secondary outcomes

  1. Interim actual and change from baseline values in UPDRS total and subscale scores, Clinical Global Impression, measures of motor performance, and neuropsychological testing.

  2. Safety:

  3. Exam

  4. vitals

  5. weight

  6. ECG

  7. laboratory tests and adverse events

Sponsors and collaborators

Lead sponsor

Kyowa Kirin, Inc.

Industry

Collaborators

  • Kyowa Kirin Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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