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NCT Number: NCT00250393

A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease

To establish the efficacy of 40 mg/day doses of istradefylline for the change in Unified Parkinson's Disease Rating Scale (UPDRS) part-III (Motor examination) score in patients with Parkinson's disease (PD).

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases 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

Tokyo, Japan

About this study

To establish the efficacy of 40mg/d doses of istradefylline for the change in UPDRS part-III (Motor examination) score in patients with Parkinson's disease (PD). Patients who meet entry criteria will be randomly assigned to receive study drug in 1 of 2 arms: Condition A (doses of 40mg/d istradefylline) in Period 1 followed by Condition B (matching placebo) in Period 2 (putting 4 weeks interval phase between two periods ) or Condition B in Period 1 followed by Condition A in Period 2(putting 4 weeks interval phase between two periods ). Patients will be participated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.
  • PD stages 1-3 for Modified Hoehn and Yahr Scale.
  • Be at least 30 years of age.

Exclusion criteria

  • Neurosurgical treatment for PD.
  • History of psychosis.
  • Diagnosis of cancer within 5 years.
  • Diagnosis of clinically significant illness of any organ system.
  • Mini-mental status examination score of 25 or less.
  • Taking any excluded medications.
  • History of drug or alcohol abuse or dependence within the past two years.
  • History of seizures or neurological malignant syndrome.
  • Clinical depression.
  • Pregnant or lactating females.

Treatment and study plan

Istradefylline (KW-6002)

Drug

Primary outcomes

  1. To establish the efficacy of 40mg/d doses of istradefylline for the change in UPDRS part-III (Motor examination) score in patients with Parkinson's disease (PD).

Secondary outcomes

  1. To evaluate the efficacy of 40mg/d dose of istradefylline for the change in UPDRS part-I (Mentation, behavior and mood), part-II (Activities of daily living) score and UPDRS total (parts I-III) score.

  2. To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).

  3. To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).

  4. To evaluate the safety of 40mg/d doses of istradefylline.

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

Placebo-Controlled , Crossover , Double-Blind Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Monotherapy]

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Nov 8, 2005
Registry last updated
Aug 29, 2012

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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