A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa - Full Text View

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.

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

Genetics Home Reference related topics:

Parkinson disease

MedlinePlus related topics:

Parkinson's Disease

ChemIDplus related topics:

Levodopa Istradefylline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/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 2 Study)

Further study details as provided by Kyowa Pharmaceutical:

Primary Outcome Measures:

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 Parkinson's disease (PD) treated with levodopa/dopa-decarboxylase inhibitor. [ Time Frame: Last Visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean percentage of awake time per day spent in the OFF state. [ Time Frame: Every Visit ] [ Designated as safety issue: No ]
To evaluate 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). [ Time Frame: Every Visit ] [ Designated as safety issue: No ]
To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS). [ Time Frame: Every Visit ] [ Designated as safety issue: No ]
To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I). [ Time Frame: Visit 4 and Last Visit ] [ Designated as safety issue: No ]
To evaluate the safety of 20 mg/day and 40mg/day doses of istradefylline [ Time Frame: Every Visit ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	360
Study Start Date:	March 2007
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

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

Detailed Description:

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 40mg/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.

Eligibility

Ages Eligible for Study:	20 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/dopa-decarboxylase inhibitor for at least one year.
Taking at least three doses and >=300mg of levodopa 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.
Be at least 20 years of age.
Be willing and able to give written informed consent.

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 25 or less.
History of drug or alcohol abuse or dependence within the past two years.
History of psychosis.
Significant drug allergies.
Taking anticonvulsants for seizures.
History of neurological malignant syndrome.
Pregnant or lactating females.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455507

Locations


Japan
	Contact Kyowa Hakko Kogyo Co., Ltd.
	Tokyo, Japan

Sponsors and Collaborators

Kyowa Hakko Kogyo Co., Ltd.

Investigators


Study Director:	Keizo Toyama	Kyowa Hakko Kogyo Co., Ltd.

More Information

Responsible Party:	Kyowa Hakko Kogyo, Ltd. ( Study Director )
Study ID Numbers:	6002-0608
First Received:	April 2, 2007
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00455507
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyowa Pharmaceutical:

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:

Nervous System Diseases

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Kyowa Hakko Kogyo Co., Ltd.
Information provided by:	Kyowa Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00455507