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Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking Levodopa (6002-009)

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ClinicalTrials.gov Identifier: NCT00955526
Recruitment Status : Completed
First Posted : August 10, 2009
Last Update Posted : August 29, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40 mg/day istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Istradefylline Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 373 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Placebo-Controlled, Double-Blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)
Study Start Date : July 2009
Primary Completion Date : February 2011
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Istradefylline 20mg Drug: Istradefylline
20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks)
Other Name: KW-6002
Experimental: Istradefylline 40mg Drug: Istradefylline
40mg KW-6002 per day (two 20 mg tablets orally once daily for 12 weeks)
Other Name: KW-6002
Placebo Comparator: Placebo Drug: Placebo
Two placebo tablets once daily for 12 weeks


Outcome Measures

Primary Outcome Measures :
  1. Reducing the mean total hours of awake time per day spent in the OFF state

Secondary Outcome Measures :
  1. Reducing the mean percentage of awake time per day spent in the OFF state
  2. Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia)
  3. Change in Unified Parkinson's Disease Rating Scale (UPDRS)
  4. Change in the Clinical Global Impression - Improvement scale (CGI-I)
  5. Adverse events

Eligibility Criteria

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be willing and able to give written informed consent
  2. UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD
  3. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale
  4. On levodopa/dopa-decarboxylase inhibitor for at least one year
  5. Taking at least three doses and >=300 mg of levodopa/dopa-decarboxylase inhibitor per day for at least four weeks before randomization
  6. Predictable end of dose wearing off
  7. Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary
  8. Have an average of two hours of OFF time on 24-hour diaries
  9. On a stable regimen of any other anti-Parkinson's drugs for at least four weeks before randomization
  10. On a stable dose of domperidone for at least 14 days before randomization

Exclusion Criteria:

  1. Taking any excluded medications
  2. Neurosurgical treatment or Transcranial Magnetic Stimulation for PD
  3. Diagnosis of cancer within 5 years
  4. Diagnosis of clinically significant illness of any organ system
  5. Diagnosis of dementia or mini-mental status examination score of 23 or less
  6. History of drug or alcohol abuse or dependence within the past two years
  7. History of psychosis
  8. History of significant drug allergies
  9. Taking anticonvulsants for seizures
  10. History of neuroleptic malignant syndrome
  11. Pregnant or lactating females
Contacts and Locations

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): NCT00955526


Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
Investigators
Study Director: Study Director Kyowa Hakko Kirin Co., Ltd
More Information

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT00955526     History of Changes
Other Study ID Numbers: 6002-009
First Posted: August 10, 2009    Key Record Dates
Last Update Posted: August 29, 2012
Last Verified: August 2012

Keywords provided by Kyowa Hakko Kirin Co., Ltd:
Parkinson's disease
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