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

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ClinicalTrials.gov Identifier: NCT00199420
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 14, 2016
Sponsor:
Information provided by:
Kyowa Kirin Pharmaceutical Development, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Istradefylline (KW-6002) Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 580 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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.
Study Start Date : July 2004
Actual Primary Completion Date : November 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa




Primary Outcome Measures :
  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 Outcome Measures :
  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.


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.
  2. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale.
  3. On levodopa/carbidopa for at least one year, stable dose in past 4 weeks.
  4. Currently take at least three doses of levodopa/carbidopa per day.
  5. Predictable end of dose wearing off.
  6. Able to satisfactorily complete Hauser version of a Parkinson's diary.
  7. Have an average of 180 minutes of OFF time on two 24 hour diaries.
  8. Be at least 30 years of age.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199420


Locations
United States, New Jersey
Kyowa Pharmaceutical Inc.
Princeton, New Jersey, United States, 08540
Kyowa Pharmaceutical
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.

ClinicalTrials.gov Identifier: NCT00199420     History of Changes
Obsolete Identifiers: NCT00203983
Other Study ID Numbers: 6002-US-018
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016

Keywords provided by Kyowa Kirin Pharmaceutical Development, Inc.:
levodopa
end of dose wearing off
OFF time

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