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

NCT00203957 | Completed Phase 3 DMC

• 2 other identifiers: 13711AKyowa Pharmaceuticals
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety profile of istradefylline

  52 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Patients who completed double-blind treatment studies 6002-US-013, 6002-US-013, 6002-US-018 immediately prior to entering this open-label trial and may have had an interuption of study drug of 14 days or less.

Drug: Istradefylline

Group B

EXPERIMENTAL

Patients who previously completed double-blind treatment studies 6002-US-013, 6002-US-018 or 6002-EU-007 or discontinued from open label study 6002-US-007 and have had an interuption of study drug greater than 14 days.

Drug: Istradefylline

Interventions

Istradefylline DRUG

Patients will receive starting dose of 40mg/d. The allowable doses are 20 and 40mg/d

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

istradefylline

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Arif Dalvi, M.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: March 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: June 11, 2013

Record last verified: 2013-06

Locations

US (1)