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

NCT ID: NCT00485069

Last Updated: 2010-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-12-31

Brief Summary

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.

Conditions

Parkinson Disease; Parkinson's Disease

Keywords

Ropinirole hydrochloride; L-dopa; Parkinson's Disease; Dopamine agonist

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ropinirole Hydrochloride

Group Type: EXPERIMENTAL

ROP

Intervention Type: DRUG

Ropinirole Hydrochloride monotherapy group (ROP): Patients will receive ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose will start at 0.75 mg/day and will be increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose will be increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose will be maintained at a level without further symptomatic improvement is expected. Concomitant use of L-dopa is prohibited during the study.

ROP+L-Dopa

Intervention Type: DRUG

Ropinirole Hydrochloride with L-Dopa adjunct therapy group (ROP+L-Dopa): Patients will receive ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose will start at 0.75 milligrams (mg)/day and will be increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose will be increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose will be maintained at a level without further symptomatic improvement is expected. The dosing regimen of L-dopa remain unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.

Interventions

ROP

Ropinirole Hydrochloride monotherapy group (ROP): Patients will receive ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose will start at 0.75 mg/day and will be increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose will be increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose will be maintained at a level without further symptomatic improvement is expected. Concomitant use of L-dopa is prohibited during the study.

Intervention Type: DRUG

ROP+L-Dopa

Ropinirole Hydrochloride with L-Dopa adjunct therapy group (ROP+L-Dopa): Patients will receive ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose will start at 0.75 milligrams (mg)/day and will be increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose will be increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose will be maintained at a level without further symptomatic improvement is expected. The dosing regimen of L-dopa remain unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.

Intervention Type: DRUG

Eligibility 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 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

GSK Clinical Disclosure

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Chiba, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Hyōgo, , Japan

GSK Investigational Site

Ibaraki, , Japan

GSK Investigational Site

Kanagawa, , Japan

GSK Investigational Site

Kanagawa, , Japan

GSK Investigational Site

Kyoto, , Japan

GSK Investigational Site

Miyagi, , Japan

GSK Investigational Site

Miyagi, , Japan

GSK Investigational Site

Numakunai, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Saga, , Japan

GSK Investigational Site

Saitama, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

Countries

Japan

Other Identifiers

108862

Identifier Type: -

Identifier Source: org_study_id