A Study of Istradefylline (KW-6002) for the Treatment of Parkinson’s Disease in Patients Taking Levodopa - Full Text View

Sponsored by:	Kyowa Hakko Kirin Pharma, Inc.
Information provided by:	Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:	NCT00199407

Purpose

To establish the efficacy of a 20 mg/day dose 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 III

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Istradefylline Carbidopa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12-Week, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of a 20 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy.

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

Primary Outcome Measures:

To establish the efficacy of a 20 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson’s disease (PD) treated with levodopa/carbidopa.

Secondary Outcome Measures:

To evaluate the efficacy of a 20 mg/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) Motor Examination score (part III) and/or in Activities of Daily Living (ADL) score (part II).
To evaluate the change in Parkinson’s Disease Questionnaire (PDQ-39) and Medical Outcomes Study 36-item Short Form (SF-36).
To evaluate the change in the Patient Global Impression - Improvement scale (PGI-I).
To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).
To evaluate the safety of a 20 mg/d dose of istradefylline.

Estimated Enrollment:	230
Study Start Date:	June 2004
Estimated Study Completion Date:	November 2005

Detailed Description:

To establish the efficacy of a 20 mg/d dose 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 to 1 ratio to either 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 as compared to placebo.

Eligibility

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

Criteria

Inclusion Criteria:

UK Parkinson’s Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.
PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale.
On levodopa/carbidopa for at least one year, stable dose in past 4 weeks.
Currently take at least three doses of levodopa/carbidopa per day.
Predictable end of dose wearing off.
Able to satisfactorily complete Hauser version of a Parkinson’s diary.
Have an average of 180 minutes of OFF time on two 24 hour diaries.
Be at least 30 years of age.

Exclusion Criteria:

Neurosurgical treatment for PD.
History of psychosis.
Diagnosis of atypical parkinsonism, secondary parkinsonism variant or Parkinson’s plus syndromes.
Diagnosis of cancer within 5 years.
Mini-mental status examination score of 25 or less.
History of seizures or neurologic malignant_syndrome.
Clinical depression.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199407

Locations

United States, New Jersey
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

Study ID Numbers:	6002-US-013
Study First Received:	September 12, 2005
Last Updated:	February 27, 2007
ClinicalTrials.gov Identifier:	NCT00199407
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

Study placed in the following topic categories:

Levodopa
Dopamine
Ganglion Cysts
Movement Disorders
Parkinson Disease
Carbidopa

Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs

Nervous System Diseases
Antiparkinson Agents
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009