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Completed

NCT Number: NCT00199420

A Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on Levodopa

To establish the efficacy of 10, 20 and 40 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.

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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 3

Primary location

Kyowa Pharmaceutical, Princeton, New Jersey, United States

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About this study

To establish the efficacy of 10, 20 and 40 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1 to 1 ratio to either istradefylline 10, 20 or 40 mg or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess efficacy and safety.

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 2-4 in the OFF state for Modified Hoehn and Yahr Scale.
  • On levodopa/carbidopa for at least one year, stable dose in past 4 weeks.
  • Currently take at least three doses of levodopa/carbidopa per day.
  • Predictable end of dose wearing off.
  • Able to satisfactorily complete Hauser version of a Parkinson's diary.
  • Have an average of 180 minutes of OFF time on two 24 hour diaries.
  • Be at least 30 years of age.

Exclusion criteria

  • Neurosurgical treatment for PD.
  • History of psychosis.
  • Diagnosis of atypical parkinsonism, secondary parkinsonism variant or Parkinson's plus syndromes.
  • Diagnosis of cancer within 5 years.
  • Mini-mental status examination score of 25 or less.
  • History of seizures or neurologic malignant_syndrome.

Treatment and study plan

Istradefylline (KW-6002)

Drug

Primary outcomes

  1. To establish the efficacy of 10, 20 and 40 mg/d istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/carbidopa.

Secondary outcomes

  1. To evaluate the dose-response of 10, 20 and 40 mg/d istradefylline using the primary efficacy outcome variable.

  2. To evaluate the efficacy of 10, 20 and 40 mg/d istradefylline for reducing the total hours of OFF time.

  3. To evaluate the change in total hours of ON time (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia).

  4. To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination score (part III) and/or in Activities of Daily Living (ADL) score (part II).

  5. To evaluate the change in Parkinson's Disease Questionnaire (PDQ-39) and Medical Outcomes Study 36-item Short Form (SF-36).

  6. To evaluate the Patient Global Impression - Improvement scale (PGI-I).

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

  8. To evaluate the safety of 10, 20, and 40 mg/d istradefylline by changes in safety parameters as noted in Section 7.2.4.

Sponsors and collaborators

Lead sponsor

Kyowa Kirin, Inc.

Industry

Registry information

Official study title

A 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of 10, 20 and 40 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy.

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
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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