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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT00199355
First received: September 12, 2005
Last updated: August 28, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Parkinson's Disease
 Drug: Istradefylline (KW-6002)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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]

Resource links provided by NLM:

Drug Information available for: Levodopa
U.S. FDA Resources

Further study details as provided by Kyowa Hakko Kirin Company, Limited:

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

Estimated Enrollment: 75
Study Start Date: April 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199355

Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
Investigators
Study Director: Study Director Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT00199355     History of Changes
Other Study ID Numbers: 6002-0406
Study First Received: September 12, 2005
Last Updated: August 28, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyowa Hakko Kirin Company, Limited:
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
 Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on June 17, 2013