12-Week, Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of 40 mg/Day KW-6002 in Parkinson's Disease Patients on Levodopa/Carbidopa

This study has been completed.
Sponsor:
Information provided by:
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00456586
First received: April 3, 2007
Last updated: June 22, 2010
Last verified: April 2007
  Purpose

12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with OFF phenomena advanced PD who were treated with levodopa/carbidopa.


Condition Intervention Phase
Parkinson's Disease
Drug: KW-6002 (istradefylline)
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 40 mg/Day KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To evaluate the safety and efficacy of 40 mg/day istradefylline for reducing OFF time in subjects with Parkinson's disease (PD) treated with levodopa/carbidopa.

Secondary Outcome Measures:
  • To establish the efficacy of 40 mg/day istradefylline for reducing motor symptoms and improving activities of daily living (ADL) in subjects with advanced PD treated with levodopa/carbidopa.

Estimated Enrollment: 180
Study Start Date: April 2002
Study Completion Date: May 2003
Detailed Description:

A 12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with OFF phenomena advanced PD who were treated with levodopa/carbidopa.

  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 (step 1 and 2).
  2. Modified Hoehn and Yahr Scale II-IV in the OFF state.
  3. Treated with levodopa/carbidopa for 1 year with a stable regimen for 4 weeks prior to randomization.
  4. Taking at least 4 doses of levodopa (3 doses if at least 2 doses containing slow release formulation) per day with predictable end of dose wearing off.
  5. Successfully completed Parkinson's disease patient diary training with at least 120 minutes of OFF time per day.
  6. Stable regimen of other antiparkinson's disease medications for at least 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/carbodopa within 4 weeks of randomization.
  2. Treatment with MAO inhibitors except selegiline.
  3. Treatment with centrally acting dopamine antagonists within 3 months (6 months for depot preparations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine.
  4. Neurosurgical surgery for Parkinson's disease.
  5. Atypical parkinsonism or secondary parkinsonism variants.
  6. Diagnosis of cancer or evidence of continued cancer within 5 years of enrollment or clinically significant illness of any organ system (e.g., ALT or AST > 1.5 times the upper limit of normal).
  7. Mini-Mental Status Examination score of 25 or less.
  8. History of drug or alcohol abuse or dependence within 2 years.
  9. History of psychotic illness or seizures.
  10. Current clinically relevant depression disorder.
  11. History of neuroleptic malignant syndrome.
  12. Pregnant or lactating females. Women of child-bearing potential must use 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: NCT00456586

Locations
United States, New Jersey
Contact Kyowa Pharmacuetical 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

ClinicalTrials.gov Identifier: NCT00456586     History of Changes
Other Study ID Numbers: 6002-US-005
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 therapy
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
Carbidopa
Levodopa
Istradefylline
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents

ClinicalTrials.gov processed this record on July 20, 2014