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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00203957
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: University of Chicago
• Public title: Study of KW-6002 (Istradefylline) in Parkinson's Disease in Patients With Motor Response Complications on Levodopa
• Scientific 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
• Date of first enrolment: March 2005
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00203957
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Arif Dalvi, M.D.
• Affiliation: University of Chicago

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Istradefylline

Primary Outcome(s)

To evaluate the safety profile of istradefylline [Time Frame: 52 weeks]

Secondary ID(s)

Kyowa Pharmaceuticals

13711A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors