REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 Study
REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 Study
Ropinirole Hydrochloride (ROP) was granted approval for the treatment of Parkinson's Disease
 (PD) on 20 October 2006.

 ROP is expected to be used for a long term in clinical practice. However, no long-term
 clinical data with ROP administered three times daily are currently available from Japanese
 patients, and the clinical experience with ROP at >10mg/day is limited.

 For this reason, this study was designed as a multicenter open-label uncontrolled study.

 This study will evaluate the long-term efficacy (Japanese Unified Parkinson's Disease Rating
 Scale (UPDRS), Awake time spent "Off"/"On", Modified Hoehn & Yahr stage, Schwab-England
 scale, Proportion of subjects remaining in this study and Clinical Global Impression (CGI))
 and the long-term safety of ROP administered three times daily for in PD patients.
Inclusion criteria:

 Subjects eligible for enrollment in the study must meet all of the following criteria. Note
 that both inpatients and outpatients are eligible.

 -  Patients with a diagnosis of PD (including juvenile parkinsonism) with Modified Hoehn
 & Yahr Stages I to IV.

 -  Patients who have been receiving another dopamine agonist for at least 4 weeks prior
 to the start of the screening phase and are expected to benefit from conversion to
 ROP.

 -  Age: 20 years (at the time of written informed consent).

 -  Informed consent: Patients who are able to give written informed consent in person
 (i.e., patients who are capable of giving written informed consent on their own).

 -  Gender: Male or female

 Females of childbearing potential are eligible for enrollment in the study, only if the
 subject has a negative pregnancy test at the start of the screening phase and agrees to
 conduct pregnancy testing at the protocol-specified visits during the study and use one of
 the following acceptable methods of contraceptions properly and accurately:

 -  Abstinence

 -  Oral contraceptive, either combined or progestogen alone

 -  Injectable progestogen

 -  Implants of levonorgestrel

 -  Estrogenic vaginal ring (Caution: This should be used cautiously, because the blood
 concentration of the study drug may be increased.)

 -  Percutaneous contraceptive patches

 -  Intrauterine device (IUD) or intrauterine system (IUS)

 -  Male partner sterilization (vasectomy with documentation of azoospermia) prior to the
 female subject's entry into the study, and this male is the sole partner for that
 subject)

 -  Double barrier method: condom or occlusive cap (diaphragm or cervical / vault caps)
 plus spermicidal agent (foam/gel/film/cream/suppository)

 Exclusion criteria:

 Subjects meeting any of the following criteria must not be enrolled in the study:

 -  Patients who present with any serious medical condition other than PD (e.g., cardiac,
 hepatic or renal disorder or hematopoietic disorder).

 Serious is defined as Grade 3 as a rule according to the Classification of the Severity of
 Adverse Experiences.

 -  Patients with postural hypotension with any subjective symptoms (e.g., dizziness and
 syncope).

 -  Patients who have had any serious psychiatric symptoms (e.g., confusion,
 hallucination, delusion, abnormal behavior) (including symptoms caused by anti-PD
 drugs) within 6 months (26 weeks) prior to written informed consent.

 -  Patients who have initiated any of the following drugs within 4 weeks of the start of
 the screening phase and have the dosing regimen of the drug changed within 4 weeks of
 the start of the screening phase.

 -  L-dopa (+DCI) (NOTE: This does not apply to the monotherapy group.)

 -  Anticholinergic agents: trihexyphenidyl hydrochloride, piroheptine hydrochloride,
 mazaticol hydrochloride, metixene hydrochloride, biperiden, profenamine

 -  amantadine hydrochloride

 -  droxidopa

 -  citicoline

 -  selegiline hydrochloride

 -  entacapone

 -  zonisamide

 -  Patients with severe dementia with a Japanese UPDRS Part I (mentation, behavior, and
 mood) score of 3 or 4.

 -  Female patients who are pregnant or lactating, who may be pregnant, or who plan for
 pregnancy during the study period or within 30 days after the last dose of the study
 drug.

 -  Patients with a history of drug allergy to any ingredients of ROP tablets.

 -  Patients who have received surgical treatment for PD in the past (e.g., pallidectomy,
 deep brain stimulation).

 -  Patients who have been treated with any other investigational product within 12 weeks
 prior to the start of the screening phase.

 -  Patients who, in the judgement of the investigator (or sub-investigator), have
 evidence of alcohol or drug abuse.

 -  Others whom the investigator (or sub-investigator) considers ineligible for the study.