Study of KW-6002 (Istradefylline) in Parkinson's Disease in Patients With Motor Response Complications on Levodopa - Full Text View

Sponsored by:	University of Chicago
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00203957

Purpose

The purpose of this study is to confirm the long term tolerability and safety of oral 20 or 40 mg/d doses of Istradefylline.

Condition	Intervention	Phase
Parkinson's Disease	Drug: Istradefylline	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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy

Further study details as provided by University of Chicago:

Primary Outcome Measures:

To evaluate the safety profile of istradefylline

Estimated Enrollment:	10
Study Start Date:	March 2005

Detailed Description:

This is a Phase III open-label study, in which patients with Parkinson’s disease (PD) who have completed a qualifying istradefylline study will be treated with istradefylline for a period of up to one additional year. Starting dosage of istradefylline will be 40 mg/d and maintenance dosage will be at the discretion of the Investigator. The available doses for istradefylline are 20 and 40 mg/d. Open-label istradefylline treatment will be initiated after a patient has satisfied all criteria for participation. Patients will undergo screening and baseline evaluations during which they will be assessed for eligibility. Screening procedures will vary slightly depending upon the allocation of patients to one of the following two groups:

Group A: Patients who have completed double-blind treatment studies 6002-US-0 13, 6002- US-Ol S or 6002-EU-007 immediately prior to entering this open-label trial and may have had an interruption of study drug of 14 days or less. The screening visit for these patients will correspond to the final visit of the previous istradefylline study.

Group B: Patients who have previously completed double-blind treatment studies 6002-US- 013, 6002-US-O 18 or 6002-EU-007 or discontinued from open-label study 6002-US-007 and have had an interruption of study drug greater than 14 days. Screening for these patients will occur at the Week -2 and Day -1 Visits. Visits should occur in the ON state and procedures should be conducted in the order specified, whenever possible.

Safety outcomes will be assessed by physical examination (including neurological examination), clinical laboratory tests and 12-lead electrocardiogram (ECG) at screening and at selected subsequent scheduled visits. Vital signs, including weight, concomitant medications, and adverse events will be monitored regularly throughout the trial. Changes in anti-parkinsonian medications will be permitted at the Investigator’s discretion.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who completed double-blind treatment study 6002-US-0 13, 6002-US-0 18 or 6002-EU-007, or who discontinued from open-label study 6002-US-007.
Patients who are female must be non-pregnant and non-nursing. Women of Child Bearing Potential (WOCBP) must use a reliable method of contraception (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive, double- bather methods, such as condom and diaphragm, condom and foam, condom and sponge or intra-uterine devices) and have a negative serum (North American sites) or urine (non-North American sites) pregnancy test at screening and at baseline. Women are considered to not be of childbearing potential if they have been surgically sterilized.
Patients who are able to give written informed consent

Exclusion Criteria:

Group B Patients who are treated within 30 days before baseline (or five half-lives of the compound, if longer) with any investigational agent other than istradefylline
Patients who have a history of a psychotic illness.
Patients who are treated within three months (six months if patient was treated with depot) before baseline or during the trial with an anti-psychotic agent.
Patients who are treated with any centrally acting drug that has known dopamine antagonist properties at therapeutic doses (e.g., buspirone, amoxapine).
Patients who have atypical parkinsonism.
Patients who have secondary parkinsonism variants.
Patients who have a diagnosis of cancer or evidence of continued malignancy within five years of study enrollment (except for patients that have had basal cell carcinoma or carcinoma in situ of the cervix surgically excised).
Patients who have a clinically significant illness of any organ system which may compromise the safety of the patient during the trial or affect the ability of the patient to complete the trial.
Patients who, for any reason, are judged by the Investigator to be inappropriate for this trial, including a patient who is unable to communicate or to cooperate with the Investigator.
Patients who have an ALT and/or an AST level greater than 1.5 ULN at screening will be ineligible to participate in the trial.
Patients who have a history of drug or alcohol abuse or dependence within the last year (DSM-IVR).
Patients with significant drug allergies.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203957

Locations

United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator:

Arif Dalvi, M.D.

University of Chicago

More Information

No publications provided

Study ID Numbers:	13711A, Kyowa Pharmaceuticals
Study First Received:	September 13, 2005
Last Updated:	March 16, 2007
ClinicalTrials.gov Identifier:	NCT00203957 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Chicago:

Parkinson's Disease

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 May 07, 2009