12-Week, Double-Blind, Placeob-Controlled Study of 20 and 60 mg/Day Istradefylline in Parkinson's Disease Patients on Levodopa/Carbodopa

This study has been completed.
Sponsor:
Information provided by:
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00456794
First received: April 3, 2007
Last updated: June 22, 2010
Last verified: April 2007
  Purpose

A 12-week, multicenter, double-blind, randomized study designed to evaluate the safety and efficacy of 20 and 60 mg/day istradefylline compared with placebo in subjects with OFF-time phenomena and advanced Parkinson's disease treated with levodopa/carbidopa.


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: A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of Doses of 20 and 60 mg/Day Istradefylline as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Pharma, Inc.:

Primary Outcome Measures:
  • Change from Baseline to Endpoint in percentage of awake time per day in an OFF state based on the subjects' valid ON/OFF Parkinson's disease diary data.

Secondary Outcome Measures:
  • Actual values and mean change from Baseline in percentage and total hours of awake time per day in the OFF state and ON state, UPDRS I-IV, II and III Scores during ON and OFF states, Global Clinical Impression-Improvement (CGI-I), safety

Estimated Enrollment: 325
Study Start Date: March 2002
Study Completion Date: October 2003
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. United Kingdom Parkinson's Disease Society brain bank diagnostic criteria (Steps 1 and 2).
  2. Modified Hoehn and Yahr in the OFF state of II-IV.
  3. Treated with levodopa/carbidopa for at least one year with a stable regimen for 4 weeks prior to randomization.
  4. Taking at least 4 doses of levodopa/carbidopa per day (3 doses if at least 2 doses contained slow-release formuation) with predictable end of dose wearing off.
  5. Successfully competed Parkinson's disease patient diary training with at least 120 minutes of OFF time per day.
  6. Stable regimen of other antiparkinson's medications for 4 weeks prior to randomization.
  7. At least 30 years of age and able to give written informed consent.

Exclusion Criteria:

  1. Treatment with liquid levodopa/carbidopa within 4 weeks of randomization.
  2. Treatment with MAO inhibitors except selegiline.
  3. Treatment within 3 months with centrally acting dopamine antagonists (6 months for depot formuations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine.
  4. Neurosurgical operation for Parkinson's disease.
  5. Atypical parkinsonism or secondary parkinsonism variants.
  6. Diagnosis of cancer or evidence of continued disease within 5 years.
  7. Clinically significant illness of any organ system (e.g., ALT or AST > 1.5 times the upper limit of normal).
  8. Mini-Mental Status Examination score of 25 or less.
  9. History of drug or alcohol abuse or dependence within 2 years.
  10. History of psychotic illness or seizures.
  11. Clinically relevant depression disorder.
  12. History of neuroleptic malignant syndrome.
  13. Pregnancy or lactation. Women of child bearing potential must use a reliable method of contraception.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456794

Locations
United States, New Jersey
Contact Kyowa Pharmaceutical, Inc.
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Kyowa Hakko Kirin Pharma, Inc.
Investigators
Study Director: Neil Sussman, MD Kyowa Hakko Kirin Pharma, Inc.
  More Information

No publications provided by Kyowa Hakko Kirin Pharma, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00456794     History of Changes
Other Study ID Numbers: 6002-US-006
Study First Received: April 3, 2007
Last Updated: June 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Kyowa Hakko Kirin Pharma, Inc.:
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 October 01, 2014