REQUIP (Ropinirole Hydrochloride)IR Long-Term Phase 4 Study

Condition(s) targeted: Parkinson's Disease

Intervention: ropinirole hydrochloride (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718

REQUIP was granted approval for the treatment of Parkinson's Disease on 20 October 2006.

REQUIP is expected to be used for a long term in clinical practice. However, no long-term clinical data with REQUIP administered three times daily are currently available from Japanese patients, and the clinical experience with REQUIP 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 (UPDRS, Awake time spent "Off"/"On", Modified Hoehn & Yahr stage, Schwab-England scale, Proportion of subjects remaining in this study and CGI) and the long-term safety of REQUIP administered three times daily for in Parkinson's Disease patients.

Official title: Post-Marketing Clinical Study of REQUIP Tablets in Patients With Parkinson's Disease - Evaluation of Long-Term Efficacy and Safety -

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Efficacy - Change from baseline in Japanese UPDRS Part III total score (recorded in an "on" state) - Change from baseline in Japanese UPDRS Part III total score

Secondary outcome: Safety - Adverse events: type, severity and frequency - Clinical laboratory tests (hematology, clinical chemistry) - ECG (standard 12-lead ECG) - Vital signs (blood pressure, pulse rate)

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 ReQuip.

- 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) that meets the SOP

effectiveness criteria as stated in the product label

- 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 (PAB/SD Notification No. 80, dated 29 June 1992) .

- 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 ReQuip.

- 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.

US GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Investigational Site, Iwate 020-8505, Japan; Recruiting

GSK Investigational Site, Tokyo 160-0017, Japan; Recruiting

GSK Investigational Site, Hyogo 651-2273, Japan; Recruiting

GSK Investigational Site, Saitama 364-8501, Japan; Recruiting

GSK Investigational Site, Miyagi 982-8555, Japan; Recruiting

GSK Investigational Site, Kanagawa 247-8533, Japan; Recruiting

GSK Investigational Site, Kanagawa 253-8558, Japan; Recruiting

GSK Investigational Site, Osaka 543-8555, Japan; Recruiting

GSK Investigational Site, Tokyo 187-8551, Japan; Recruiting

GSK Investigational Site, Saga 849-8501, Japan; Recruiting

GSK Investigational Site, Osaka 590-0132, Japan; Recruiting

GSK Investigational Site, Chiba 270-2251, Japan; Recruiting

GSK Investigational Site, Osaka 598-0048, Japan; Recruiting

GSK Investigational Site, Miyagi 989-2202, Japan; Recruiting

GSK Investigational Site, Kyoto 616-8255, Japan; Recruiting

GSK Investigational Site, Fukuoka 819-8585, Japan; Recruiting

GSK Investigational Site, Ibaraki 300-0053, Japan; Recruiting

GSK Investigational Site, Tokyo 154-8551, Japan; Recruiting

GSK Investigational Site, Osaka 578-8588, Japan; Recruiting

GSK Investigational Site, Osaka 558-8558, Japan; Recruiting

GSK Investigational Site, Fukuoka 816-0943, Japan; Recruiting

GSK Investigational Site, Tokushima 776-8585, Japan; Withdrawn

GSK Investigational Site, Fukuoka 802-0071, Japan; Withdrawn

GSK Investigational Site, Okayama 710-0803, Japan; Withdrawn

Starting date: June 2007
Ending date: March 2010
Last updated: October 16, 2008