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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1175

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

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 with a dose equivalent higher than quetiapine 100 mg/day for levodopa or Parkinson’s disease-induced hallucinations.

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials