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

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ClinicalTrials.gov Identifier: NCT00199355
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 23, 2014
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd

Study Description
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Brief Summary:
To establish the efficacy of 20 mg/day and 40 mg/day doses 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 2

Detailed Description:
To establish the efficacy of 20 mg/d and 40mg/d doses 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 1:1:1 ratio to double blind treatment with oral doses of 20 or 40mg/d 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Placebo-Controlled , Double-Blind , Exploratory Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Adjunctive Therapy to Levodopa]
Study Start Date : April 2005
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To establish the efficacy of 20 mg/d and 40mg/d doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/DCI.

Secondary Outcome Measures :
  1. To evaluate the efficacy of 20 mg/d and 40mg/d dose of istradefylline for reducing the total hours of OFF time.
  2. To evaluate the change in percentage of ON time (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia).
  3. To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS).
  4. To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).
  5. To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).
  6. To evaluate the safety of 20 mg/d and 40mg/d doses of istradefylline.

Eligibility Criteria
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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/DCI for at least one year, stable dose in past 4 weeks.
  4. Currently take at least three doses of levodopa/DCI 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 120 minutes of OFF time on two 24 hour diaries.
  8. On a stable regimen of medications being administered within normal therapeutic limits for Parkinson's disease for at least four weeks before randomization.
  9. Be at least 30 years of age.

Exclusion Criteria:

  1. Neurosurgical treatment for PD.
  2. History of psychosis.
  3. Diagnosis of atypical Parkinsonism or secondary Parkinsonism variant.
  4. Diagnosis of cancer within 5 years.
  5. Diagnosis of clinically significant illness of any organ system.
  6. Mini-mental status examination score of 25 or less.
  7. Taking any excluded medications.
  8. History of drug or alcohol abuse or dependence within the past two years.
  9. History of seizures or neurological malignant syndrome.
  10. Clinical depression.
  11. Pregnant or lactating females.
Contacts and Locations
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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): NCT00199355


Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
Investigators
Study Director: Study Director Kyowa Hakko Kirin Co., Ltd
More Information
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Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT00199355     History of Changes
Other Study ID Numbers: 6002-0406
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 23, 2014
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