Parkinson DiseasePhase 4NCT00485069
REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 Study
A Phase 4 study testing ROP and ROP+L-Dopa in people with Parkinson Disease and Parkinson's Disease, run by GlaxoSmithKline at 22 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Parkinson Disease, Parkinson's Disease
- What is being tested?
- ROP and ROP+L-Dopa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 22 sitesJapan
- Study dates
- Jun 2007to Dec 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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)
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Japan22 sites
GSK Investigational Site
Chiba, 270-2251
GSK Investigational Site
Fukuoka, 814-0180
GSK Investigational Site
Fukuoka, 816-0943
GSK Investigational Site
Fukuoka, 819-8585
GSK Investigational Site
Hyōgo, 651-2273
GSK Investigational Site
Ibaraki, 300-0053
GSK Investigational Site
Kanagawa, 247-8533
GSK Investigational Site
Kanagawa, 253-8558
GSK Investigational Site
Kyoto, 616-8255
GSK Investigational Site
Miyagi, 982-8555
GSK Investigational Site
Miyagi, 989-2202
GSK Investigational Site
Numakunai, 020-8505
GSK Investigational Site
Osaka, 543-8555
GSK Investigational Site
Osaka, 558-8558
GSK Investigational Site
Osaka, 578-8588
GSK Investigational Site
Osaka, 590-0132
GSK Investigational Site
Osaka, 598-0048
GSK Investigational Site
Saga, 849-8501
GSK Investigational Site
Saitama, 364-8501
GSK Investigational Site
Tokyo, 154-8551
GSK Investigational Site
Tokyo, 160-0017
GSK Investigational Site
Tokyo, 187-8551
About this study
Official title: Post-Marketing Clinical Study of REQUIP (Ropinirole Hydrochloride) Tablets in Patients With Parkinson's Disease- Evaluation of Long-Term Efficacy and Safety -
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.
Read more
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
- Being tested
- ROP, ROP+L-Dopa
- Keywords
- Ropinirole hydrochloride, L-dopa, Parkinson's Disease, Dopamine agonist
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROPDrug
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-DopaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ropinirole Hydrochloride | Experimental | Not described Receives: Drug: ROP; Drug: ROP+L-Dopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score (in "On" State for the ROP+L-Dopa Group) at Week 52 and Final Assessment Point (FAP)
The Japanese UPDRS assesses the status of Parkinson's Disease (PD) patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. "On" state is where PD symptoms are well controlled by the drug. Participants with "off" state at baseline or without post-baseline data were not included in the ROP+L-dopa group at FAP. These participants as well as one with "off" state at Week 52 and those prematurely withdrawn were not included at Week 52.
Measured: Baseline, Week 52, and FAP (up to Week 52)
Secondary outcomes (22)
Mean Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP
The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.
Measured: Baseline, Week 52, and FAP (up to Week 52)
Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP by "On"/"Off" State in the ROP+L-Dopa Group
The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "On" state is where PD symptoms are well controlled by the drug. "Off" state is where PD symptoms are not adequately controlled by the drug.
Measured: Baseline, Week 52, and FAP (up to Week 52)
Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group
The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.
Measured: Baseline, Week 52, and FAP (up to Week 52)
Mean Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP
The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.
Measured: Baseline, Week 52, and FAP (up to Week 52)
Japanese UPDRS Part I Mean Total Score at Baseline, Week 52, and FAP
The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.
Measured: Baseline, Week 52, and FAP (up to Week 52)
Mean Percent Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP
The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.
Measured: Baseline, Week 52, and FAP (up to Week 52)
Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP by "On"/"Off" State in the ROP+L-Dopa Group
The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "On" state is where PD symptoms are well controlled by the drug. "Off" state is where PD symptoms are not adequately controlled by the drug. LOCF was used for the FAP data. Some participants were not included at FAP as having no post-baseline data in "on" state or having no data in "off" state at Week 52/withdrawal.
Measured: Baseline, Week 52, and FAP (up to Week 52)
Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP in ROP Group
The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.
Measured: Baseline, Week 52, and FAP (up to Week 52)
Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP by "On"/"Off" State in the ROP+L-Dopa Group
The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "On" state is where PD symptoms are well controlled by the drug. "Off" state is where PD symptoms are not adequately controlled by the drug. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.
Measured: Baseline, Week 52, and FAP (up to Week 52)
Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group
The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.
Measured: Baseline, Week 52, and FAP (up to Week 52)
Japanese UPDRS Part III Mean Total Score (in "On" State for the ROP+L-Dopa Group) at Baseline, Week 52, and FAP
The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. "On" state is where PD symptoms are well controlled by the drug. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data.
Measured: Baseline, Week 52, and FAP (up to Week 52)
Mean Percent Change From Baseline in the Japanese UPDRS Part III Total Score (in "On" State for the ROP+L-Dopa Group) at Week 52 and FAP
The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. "On" state is where PD symptoms are well controlled by the drug. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.
Measured: Baseline, Week 52, and FAP (up to Week 52)
Japanese UPDRS Part IV Mean Total Score at Baseline, Week 52, and FAP
The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.
Measured: Baseline, Week 52, and FAP (up to Week 52)
Mean Percent Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP
The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.
Measured: Baseline, Week 52, and FAP (up to Week 52)
Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP by "On"/"Off" State in the ROP+L-Dopa Group
The Modified Hoehn \& Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. LOCF was used for the FAP data to impute post-baseline missing values. Some participants in each state were not included at FAP as having no post-baseline data in the corresponding state or having no data in the corresponding state at Week 52/withdrawal.
Measured: Baseline, Week 52, and FAP (up to Week 52)
Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group
The Modified Hoehn \& Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided.
Measured: Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group
Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP by "On"/"Off" State in the ROP+L-Dopa Group
The Schwab and England Activities of Daily Living Scale Score is measured as percentage, from 100% (Completely independent. Able to do all chores without slowness, difficulty or impairment. Essentially normal. Unaware of any difficulty) to 0% (Vegetative functions such as swallowing, bladder and bowel functions are not functioning. Bedridden).
Measured: Baseline, Week 52, and FAP (up to Week 52)
Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP in ROP Group
The Schwab and England Activities of Daily Living Scale Score is measured as percentage, from 100% (Completely independent. Able to do all chores without slowness, difficulty or impairment. Essentially normal. Unaware of any difficulty) to 0% (Vegetative functions such as swallowing, bladder and bowel functions are not functioning. Bedridden).
Measured: Baseline, Week 52, and FAP (up to Week 52)
Percentage of Participants Remaining in the Study on the Indicated Days in the ROP+L-Dopa Group
The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 52) was the event, and participants who had completed the study were censored.
Measured: Days 0-422
Percentage of Participants Remaining in the Study on the Indicated Days in the ROP Group
The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 52) was the event, and participants who had completed the study were censored.
Measured: Days 0-419
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale at Week 52 and FAP
CGI is measured on the following 7-point scale: 1, Very much improved; 2, Much Improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; and 7, Very much worse. Responders are defined as those participants scored as "very much improved" or "much improved."
Measured: Week 52 and FAP (up to Week 52)
Mean Change From Baseline in Awake Time "Off" (Hours) and Awake Time "On" (Hours) at Week 52 and FAP in the ROP+L-Dopa Group Excluding Participants With "0" Off (Hour) at Baseline
"Off" state is where PD symptoms are not adequately controlled by the drug. "On" state is where PD symptoms are well controlled by the drug. The "off's" duration (awake time spent "off") and the "on's" duration (awake time spent "on") on each day were calculated.
Measured: Baseline, Week 52, and FAP (up to Week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485069
- Sponsor's protocol ID
- 108862
- Status last verified
- Nov 2010
- First submitted
- 11 Jun 2007
- Last updated
- 15 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Clinical Study of REQUIP (Ropinirole Hydrochloride) Tablets in Patients With Parkinson's Disease- Evaluation of Long-Term Efficacy and Safety -
- ClinicalTrials.gov ID
- NCT00485069
- Acronym / sponsor ID
- 108862
- Conditions
- Parkinson Disease, Parkinson's Disease
- Keywords
- Ropinirole hydrochloride, L-dopa, Parkinson's Disease, Dopamine agonist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 12 Jun 2007 (estimated)
- Results
- Posted 15 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ropinirole Hydrochloride | Experimental | Drug: ROP, Drug: ROP+L-Dopa |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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).
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROPRopinirole 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. | Drug | Ropinirole Hydrochloride |
| ROP+L-DopaRopinirole 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. | Drug | Ropinirole Hydrochloride |
Primary outcome
Mean Change From Baseline in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score (in "On" State for the ROP+L-Dopa Group) at Week 52 and Final Assessment Point (FAP)
Time frame: Baseline, Week 52, and FAP (up to Week 52)
The Japanese UPDRS assesses the status of Parkinson's Disease (PD) patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. "On" state is where PD symptoms are well controlled by the drug. Participants with "off" state at baseline or without post-baseline data were not included in the ROP+L-dopa group at FAP. These participants as well as one with "off" state at Week 52 and those prematurely withdrawn were not included at Week 52.
22 secondary outcomes
Mean Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP
Time frame: Baseline, Week 52, and FAP (up to Week 52)
Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP by "On"/"Off" State in the ROP+L-Dopa Group
Time frame: Baseline, Week 52, and FAP (up to Week 52)
Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group
Time frame: Baseline, Week 52, and FAP (up to Week 52)
Mean Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP
Time frame: Baseline, Week 52, and FAP (up to Week 52)
Japanese UPDRS Part I Mean Total Score at Baseline, Week 52, and FAP
Time frame: Baseline, Week 52, and FAP (up to Week 52)
Mean Percent Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP
Time frame: Baseline, Week 52, and FAP (up to Week 52)
Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP by "On"/"Off" State in the ROP+L-Dopa Group
Time frame: Baseline, Week 52, and FAP (up to Week 52)
Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP in ROP Group
Time frame: Baseline, Week 52, and FAP (up to Week 52)
Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP by "On"/"Off" State in the ROP+L-Dopa Group
Time frame: Baseline, Week 52, and FAP (up to Week 52)
Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group
Time frame: Baseline, Week 52, and FAP (up to Week 52)
Japanese UPDRS Part III Mean Total Score (in "On" State for the ROP+L-Dopa Group) at Baseline, Week 52, and FAP
Time frame: Baseline, Week 52, and FAP (up to Week 52)
Mean Percent Change From Baseline in the Japanese UPDRS Part III Total Score (in "On" State for the ROP+L-Dopa Group) at Week 52 and FAP
Time frame: Baseline, Week 52, and FAP (up to Week 52)
Japanese UPDRS Part IV Mean Total Score at Baseline, Week 52, and FAP
Time frame: Baseline, Week 52, and FAP (up to Week 52)
Mean Percent Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP
Time frame: Baseline, Week 52, and FAP (up to Week 52)
Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP by "On"/"Off" State in the ROP+L-Dopa Group
Time frame: Baseline, Week 52, and FAP (up to Week 52)
Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group
Time frame: Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group
Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP by "On"/"Off" State in the ROP+L-Dopa Group
Time frame: Baseline, Week 52, and FAP (up to Week 52)
Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP in ROP Group
Time frame: Baseline, Week 52, and FAP (up to Week 52)
Percentage of Participants Remaining in the Study on the Indicated Days in the ROP+L-Dopa Group
Time frame: Days 0-422
Percentage of Participants Remaining in the Study on the Indicated Days in the ROP Group
Time frame: Days 0-419
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale at Week 52 and FAP
Time frame: Week 52 and FAP (up to Week 52)
Mean Change From Baseline in Awake Time "Off" (Hours) and Awake Time "On" (Hours) at Week 52 and FAP in the ROP+L-Dopa Group Excluding Participants With "0" Off (Hour) at Baseline
Time frame: Baseline, Week 52, and FAP (up to Week 52)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ROP and ROP+L-Dopa in people with Parkinson Disease and Parkinson's Disease, run by GlaxoSmithKline at 22 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score (in "On" State for the ROP+L-Dopa Group) at Week 52 and Final Assessment Point (FAP) (time frame: Baseline, Week 52, and FAP (up to Week 52)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2010; AzTrials last refreshed its copy on 30 Oct 2026.