A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients
This study has been completed.
Sponsor:
Kyowa Hakko Kirin Pharma, Inc.
Information provided by:
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00199433
First received: September 12, 2005
Last updated: June 22, 2010
Last verified: February 2007
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Purpose
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40 mg per day of istradefylline (KW6002) as monotherapy in patients with Parkinson's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease Movement Disorder Syndrome |
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: | A Phase 2, Double-blind, Placebo-controlled, Randomized, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of 40mg/Day KW-6002 (Istradefylline) as Monotherapy in Subjects With Parkinson's Disease |
Resource links provided by NLM:
Further study details as provided by Kyowa Hakko Kirin Pharma, Inc.:
Primary Outcome Measures:
- Change from baseline in the UPDRS subscale III at endpoint.
Secondary Outcome Measures:
- Interim actual and change from baseline values in UPDRS total and subscale scores, Clinical Global Impression, measures of motor performance, and neuropsychological testing.
- Safety:
- Exam
- vitals
- weight
- ECG
- laboratory tests and adverse events
| Estimated Enrollment: | 160 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | August 2006 |
Parkinson's disease is a progressive disease which results in deterioration of motor function and is the result of dopamine depletion in specific brain structures. Current therapeutic approaches include dopamine replacement and the use of dopamine receptor agonist drugs. These therapies are effective but may be associated with unwanted complications like wearing off phenomena and involuntary abnormal movements (dyskinesia). Istradefylline may provide a nondopaminergic approach to the treatment of Parkinson's disease.
This study will compare the efficacy of 40 mg per day of istradefylline in improving the symptoms of Parkinson's disease with placebo.
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Early PD by UKPDS criteria
- Mild to moderate difficulty daily activities
- Females: Either postmenopausal or willing to use adequate contraception
Exclusion Criteria:
- Unable to discontinue current PD medication
- Exposure to Levodopa for more than 1 month
- Symptoms that may suggest a diagnosis other than Parkinson's disease
- Medical conditions and/or abnormal laboratory findings which preclude participation including cancer in the last 5 years, a history of drug abuse/dependence, abnormal cognitive status, a history of seizures, neuroleptic malignant syndrome, psychosis, or abnormal liver function tests
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199433
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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00199433 History of Changes |
| Other Study ID Numbers: | 6002-US-051 |
| Study First Received: | September 12, 2005 |
| Last Updated: | June 22, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Kyowa Hakko Kirin Pharma, Inc.:
|
Parkinson's Disease Movement Disorder Neurology, Clinical Trial |
Additional relevant MeSH terms:
|
Movement Disorders Parkinson Disease Central Nervous System Diseases Nervous System Diseases Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Neurodegenerative Diseases Istradefylline |
Adenosine A2 Receptor Antagonists Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013