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

Purpose

To establish the efficacy of 20 mg/day and 40 mg/day doses 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 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:	Placebo-Controlled , Double-Blind , Exploratory Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Adjunctive Therapy to Levodopa]

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa

U.S. FDA Resources

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

Primary Outcome Measures:

To establish the efficacy of 20 mg/d and 40mg/d doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/DCI.

Secondary Outcome Measures:

To evaluate the efficacy of 20 mg/d and 40mg/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).
To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).
To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).
To evaluate the safety of 20 mg/d and 40mg/d doses of istradefylline.


Estimated Enrollment:	75
Study Start Date:	April 2005
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Detailed Description:

To establish the efficacy of 20 mg/d and 40mg/d doses 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 1:1:1 ratio to double blind treatment with oral doses of 20 or 40mg/d 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:	30 Years and older (Adult, Senior)
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/DCI for at least one year, stable dose in past 4 weeks.
Currently take at least three doses of levodopa/DCI per day.
Predictable end of dose wearing off.
Able to satisfactorily complete Hauser version of a Parkinson's diary.
Have an average of 120 minutes of OFF time on two 24 hour diaries.
On a stable regimen of medications being administered within normal therapeutic limits for Parkinson's disease for at least four weeks before randomization.
Be at least 30 years of age.

Exclusion Criteria:

Neurosurgical treatment for PD.
History of psychosis.
Diagnosis of atypical Parkinsonism or secondary Parkinsonism variant.
Diagnosis of cancer within 5 years.
Diagnosis of clinically significant illness of any organ system.
Mini-mental status examination score of 25 or less.
Taking any excluded medications.
History of drug or alcohol abuse or dependence within the past two years.
History of seizures or neurological malignant syndrome.
Clinical depression.
Pregnant or lactating females.

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: NCT00199355

Locations


Japan

Tokyo, Japan

Sponsors and Collaborators

Kyowa Hakko Kirin Company, Limited

Investigators


Study Director:	Study Director	Kyowa Hakko Kirin Company, Limited

More Information


Responsible Party:	Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:	NCT00199355 History of Changes
Other Study ID Numbers:	6002-0406
Study First Received:	September 12, 2005
Last Updated:	May 21, 2014
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyowa Hakko Kirin Company, Limited:


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 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 September 23, 2016