Parkinson's Disease
Conditions
Interventions
Product Name: Istradefylline
Product Code: KW-6002
Pharmaceutical Form: Tablet
INN or Proposed INN: Istradefylline
Current Sponsor code: KW-6002
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Kyowa Hakko U.K. Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who completed double-blind treatment study 6002-US-013, 6002-US-018 or 6002-EU-007, or who discontinued from open-label study 6002-US-007. 2) 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, doublebarrier 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 (physician-documented hysterectomy or tubal ligation) or if they are postmenopausal [complete absence of menses for two consecutive years and a serum FSH level of > 30 IU/L in the absence of hormone replacement therapy (HRT)]. 3) Patients who are able to give written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1)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. 2)Patients who have a history of a psychotic illness. 3)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. 4)Patients who are treated with any centrally acting drug that has known dopamine antagonist properties at therapeutic doses (e.g., buspirone, amoxapine). 5)Patients who have atypical parkinsonism. 6)Patients who have secondary parkinsonism variants. 7)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). 8)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. 9)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. 10)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. 11)Patients who have a history of drug or alcohol abuse or dependence within the last year (DSM-IVR). 12)Patients with significant drug allergies. 13)Patients who, in the opinion of the Investigator, currently have a clinically relevant depression (whether or not under active treatment). 14)Patients who have a history of seizures or seizure disorders. 15)Patients who have a history of neuroleptic malignant syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the long-term tolerability and safety of oral 20 or 40 mg/d doses of istradefylline.;Secondary Objective: ;Primary end point(s): The following information will be collected to evaluate the safety profile of istradefylline in the study population: •Adverse events •Complete medical history •Physical examination (including full neurological examination) •Vital signs, including weight •Clinical laboratory tests (chemistry, hematology, and urinalysis) •12-Lead ECG | — |
Countries
Estonia, Italy, Latvia, Lithuania, Spain, United Kingdom
Outcome results
None listed