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

Sponsored by:	Kyowa Hakko Kirin Company, Limited
Information provided by:	Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:	NCT00955526

Purpose

The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state 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 40 mg/day 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.

Condition	Intervention	Phase
Parkinson's Disease	Drug: Istradefylline Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Placebo-Controlled, Double-Blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)

Resource links provided by NLM:

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

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Istradefylline

U.S. FDA Resources

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

Primary Outcome Measures:

Reducing the mean total hours of awake time per day spent in the OFF state [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reducing the mean percentage of awake time per day spent in the OFF state [ Designated as safety issue: No ]
Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia) [ Designated as safety issue: No ]
Change in Unified Parkinson's Disease Rating Scale (UPDRS) [ Designated as safety issue: No ]
Change in the Clinical Global Impression - Improvement scale (CGI-I) [ Designated as safety issue: No ]
Adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment:	360
Study Start Date:	June 2009
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Istradefylline 20mg: Experimental	Drug: Istradefylline 20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks)
Istradefylline 40mg: Experimental	Drug: Istradefylline 40mg KW-6002 per day (two 20 mg tablets orally once daily for 12 weeks)
Placebo: Placebo Comparator	Drug: Placebo Two placebo tablets once daily for 12 weeks

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Be willing and able to give written informed consent
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/dopa-decarboxylase inhibitor for at least one year
Taking at least three doses and >=300 mg of levodopa/dopa-decarboxylase inhibitor per day for at least four weeks before randomization
Predictable end of dose wearing off
Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary
Have an average of two hours of OFF time on 24-hour diaries
On a stable regimen of any other anti-Parkinson's drugs for at least four weeks before randomization
On a stable dose of domperidone for at least 14 days before randomization

Exclusion Criteria:

Taking any excluded medications
Neurosurgical treatment or Transcranial Magnetic Stimulation for PD
Diagnosis of cancer within 5 years
Diagnosis of clinically significant illness of any organ system
Diagnosis of dementia or mini-mental status examination score of 23 or less
History of drug or alcohol abuse or dependence within the past two years
History of psychosis
History of significant drug allergies
Taking anticonvulsants for seizures
History of neuroleptic malignant syndrome
Pregnant or lactating females

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955526

Contacts

Contact: Clinical Science Department

clinical.info@kyowa-kirin.co.jp

Locations

Japan
	Recruiting
Tokyo, Japan

Sponsors and Collaborators

Kyowa Hakko Kirin Company, Limited

Investigators

Study Director:

Hideo Ohta

Kyowa Hakko Kirin Co., Ltd.

More Information

No publications provided

Responsible Party:	( Kyowa Hakko Kirin Company, Limited )
Study ID Numbers:	6002-009
Study First Received:	August 7, 2009
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00955526 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Kyowa Hakko Kirin Company, Limited:

Parkinson's disease
levodopa
end of dose wearing off
OFF time

Study placed in the following topic categories:

Levodopa
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on September 11, 2009