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CompletedNCT00485069Updated Dec 15, 2010Results posted

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

A Phase 4 interventional study of ROP and ROP+L-Dopa in Parkinson Disease and Parkinson's Disease, sponsored by GlaxoSmithKline. Completed at 22 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2010-12-15.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
123
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Parkinson Disease
  • Parkinson's Disease

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Keywords

  • Ropinirole hydrochloride
  • L-dopa
  • Parkinson's Disease
  • Dopamine agonist
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 123 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
123 participants (actual)

Study arms

  • Experimental
    Ropinirole Hydrochloride

    Drug: ROP · Drug: ROP+L-Dopa

Interventions

  • DrugROP

    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.

  • DrugROP+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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Week 52, and FAP (up to Week 52)

Secondary outcomes

  1. 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.

    Time frame: Baseline, Week 52, and FAP (up to Week 52)

  2. 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.

    Time frame: Baseline, Week 52, and FAP (up to Week 52)

  3. 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.

    Time frame: Baseline, Week 52, and FAP (up to Week 52)

  4. 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.

    Time frame: Baseline, Week 52, and FAP (up to Week 52)

  5. 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.

    Time frame: Baseline, Week 52, and FAP (up to Week 52)

  6. 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.

    Time frame: Baseline, Week 52, and FAP (up to Week 52)

  7. 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.

    Time frame: Baseline, Week 52, and FAP (up to Week 52)

  8. 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.

    Time frame: Baseline, Week 52, and FAP (up to Week 52)

  9. 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.

    Time frame: Baseline, Week 52, and FAP (up to Week 52)

  10. 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.

    Time frame: Baseline, Week 52, and FAP (up to Week 52)

  11. 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.

    Time frame: Baseline, Week 52, and FAP (up to Week 52)

  12. 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.

    Time frame: Baseline, Week 52, and FAP (up to Week 52)

  13. 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.

    Time frame: Baseline, Week 52, and FAP (up to Week 52)

  14. 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.

    Time frame: Baseline, Week 52, and FAP (up to Week 52)

  15. 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.

    Time frame: Baseline, Week 52, and FAP (up to Week 52)

  16. 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.

    Time frame: Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group

  17. 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).

    Time frame: Baseline, Week 52, and FAP (up to Week 52)

  18. 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).

    Time frame: Baseline, Week 52, and FAP (up to Week 52)

  19. 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.

    Time frame: Days 0-422

  20. 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.

    Time frame: Days 0-419

  21. 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."

    Time frame: Week 52 and FAP (up to Week 52)

  22. 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.

    Time frame: Baseline, Week 52, and FAP (up to Week 52)

07

Results

Posted Dec 15, 2010

Participant flow

Participant flow — Overall Study
MilestoneROP+L-DopaRopinirole Hydrochloride
Started6558
Completed4746
Not completed1812
Withdrew: Adverse event104
Withdrew: Lack of efficacy21
Withdrew: Protocol violation01
Withdrew: Withdrawal by subject66

Outcome measures

PrimaryMean 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.

Time frame:
Baseline, Week 52, and FAP (up to Week 52)
Reported as:
Mean · units on a scale
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)
units on a scaleROP+L-DopaRopinirole Hydrochloride
Week 52, n=45, 46-7.0 ± 8.17-6.9 ± 7.56
FAP, n=61, 58-5.8 ± 8.33-5.5 ± 8.08
SecondaryMean 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.

Time frame:
Baseline, Week 52, and FAP (up to Week 52)
Reported as:
Mean · units on a scale
Mean Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP
units on a scaleROP+L-DopaRopinirole Hydrochloride
Week 52, n=47, 46-0.4 ± 1.11-0.1 ± 0.90
FAP, n=64, 58-0.2 ± 1.26-0.0 ± 0.96
SecondaryMean 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.

Time frame:
Baseline, Week 52, and FAP (up to Week 52)
Reported as:
Mean · units on a scale
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
units on a scaleROP+L-Dopa, "On" StateROP+L-Dopa, "Off" State (Only Participants With "Off" State)
Week 52, n=47, 13-3.5 ± 4.19-2.8 ± 3.77
FAP, n=64, 22-2.3 ± 4.54-0.3 ± 6.46
SecondaryMean 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.

Time frame:
Baseline, Week 52, and FAP (up to Week 52)
Reported as:
Mean · units on a scale
Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group
units on a scaleRopinirole Hydrochloride
Week 52, n=46-2.2 ± 3.60
FAP, n=58-1.8 ± 3.86
SecondaryMean 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.

Time frame:
Baseline, Week 52, and FAP (up to Week 52)
Reported as:
Mean · units on a scale
Mean Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP
units on a scaleROP+L-DopaRopinirole Hydrochloride
Week 52, n=47, 460.1 ± 1.540.3 ± 1.24
FAP, n=64, 580.3 ± 1.750.3 ± 1.15
SecondaryJapanese 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.

Time frame:
Baseline, Week 52, and FAP (up to Week 52)
Reported as:
Mean · units on a scale
Japanese UPDRS Part I Mean Total Score at Baseline, Week 52, and FAP
units on a scaleROP+L-DopaRopinirole Hydrochloride
Baseline, n=65, 580.8 ± 1.350.8 ± 1.10
Week 52, n=47, 460.4 ± 0.770.7 ± 1.11
FAP, n=64, 580.7 ± 1.300.8 ± 1.15
SecondaryMean 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.

Time frame:
Baseline, Week 52, and FAP (up to Week 52)
Reported as:
Mean · percent change in score
Mean Percent Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP
percent change in scoreROP+L-DopaRopinirole Hydrochloride
Week 52, n=19, 22-68.86 ± 41.929-22.73 ± 79.772
FAP, n=27, 26-38.09 ± 109.715-21.92 ± 73.595
SecondaryJapanese 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.

Time frame:
Baseline, Week 52, and FAP (up to Week 52)
Reported as:
Mean · units on a scale
Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP by "On"/"Off" State in the ROP+L-Dopa Group
units on a scaleROP+L-Dopa, "On" StateROP+L-Dopa, "Off" Sate (Only Participants With "Off" State)
Baseline, n=65, 277.9 ± 5.5114.3 ± 9.04
Week 52, n=47, 164.1 ± 4.3711.4 ± 5.93
FAP, n=64, 265.5 ± 6.1815.2 ± 10.98
SecondaryJapanese 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.

Time frame:
Baseline, Week 52, and FAP (up to Week 52)
Reported as:
Mean · units on a scale
Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP in ROP Group
units on a scaleRopinirole Hydrochloride
Baseline, n=587.7 ± 4.59
Week 52, n=465.4 ± 4.65
FAP, n=585.9 ± 4.52
SecondaryMean 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.

Time frame:
Baseline, Week 52, and FAP (up to Week 52)
Reported as:
Mean · percent change in score
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
percent change in scoreROP+L-Dopa, "On" StateROP+L-Dopa, "Off" State (Only Participants With "Off" State)
Week 52, n=47, 13-48.98 ± 45.862-17.68 ± 31.381
FAP, n=62, 22-29.00 ± 73.391-4.10 ± 36.155
SecondaryMean 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.

Time frame:
Baseline, Week 52, and FAP (up to Week 52)
Reported as:
Mean · percent change in score
Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group
percent change in scoreRopinirole Hydrochloride
Week 52, n=44-24.35 ± 59.429
FAP, n=56-16.74 ± 61.175
SecondaryJapanese 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.

Time frame:
Baseline, Week 52, and FAP (up to Week 52)
Reported as:
Mean · units on a scale
Japanese UPDRS Part III Mean Total Score (in "On" State for the ROP+L-Dopa Group) at Baseline, Week 52, and FAP
units on a scaleROP+L-DopaRopinirole Hydrochloride
Baseline, n=62,5820.5 ± 12.4419.8 ± 12.10
Week 52, n=46, 4612.7 ± 10.2613.1 ± 10.86
FAP, n=64, 5814.3 ± 12.2014.3 ± 11.01
SecondaryMean 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.

Time frame:
Baseline, Week 52, and FAP (up to Week 52)
Reported as:
Mean · percent change in score
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
percent change in scoreROP+L-DopaRopinirole Hydrochloride
Week 52, n=45, 46-36.83 ± 40.001-37.73 ± 34.739
FAP, n=61, 58-30.42 ± 41.427-27.79 ± 42.531
SecondaryJapanese 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.

Time frame:
Baseline, Week 52, and FAP (up to Week 52)
Reported as:
Mean · units on a scale
Japanese UPDRS Part IV Mean Total Score at Baseline, Week 52, and FAP
units on a scaleROP+L-DopaRopinirole Hydrochloride
Baseline, n=65, 582.1 ± 3.010.5 ± 1.17
Week 52, n=47, 461.5 ± 1.770.8 ± 1.33
FAP, n=64, 582.4 ± 3.300.8 ± 1.26
SecondaryMean 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.

Time frame:
Baseline, Week 52, and FAP (up to Week 52)
Reported as:
Mean · percent change in score
Mean Percent Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP
percent change in scoreROP+L-DopaRopinirole Hydrochloride
Week 52, n=23, 17-8.70 ± 62.8890.00 ± 115.920
FAP, n=37, 2013.30 ± 91.068-2.50 ± 109.394
SecondaryNumber 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.

Time frame:
Baseline, Week 52, and FAP (up to Week 52)
Reported as:
Number · participants
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
participantsROP+L-Dopa, "On" StateROP+L-Dopa, "Off" State (Only Participants With "Off" State)
Baseline, n=65, 27, Stage 000
Baseline, n=65, 27, Stage 150
Baseline, n=65, 27, Stage 1.531
Baseline, n=65, 27, Stage 2222
Baseline, n=65, 27, Stage 2.5169
Baseline, n=65, 27, Stage 3167
Baseline, n=65, 27, Stage 436
Baseline, n=65, 27, Stage 502
Week 52, n=47, 16, Stage 010
Week 52, n=47, 16, Stage 1101
Week 52, n=47, 16, Stage 1.561
Week 52, n=47, 16, Stage 2151
Week 52, n=47, 16, Stage 2.564
Week 52, n=47, 16, Stage 384
Week 52, n=47, 16, Stage 414
Week 52, n=47, 16, Stage 501
FAP, n=63, 25, Stage 010
FAP, n=63, 25, Stage 1131
FAP, n=63, 25, Stage 1.571
FAP, n=63, 25, Stage 2211
FAP, n=63, 25, Stage 2.575
FAP, n=63, 25, Stage 3117
FAP, n=63, 25, Stage 437
FAP, n=63, 25, Stage 503
SecondaryNumber 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.

Time frame:
Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group
Reported as:
Number · participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group
participantsRopinirole Hydrochloride
Baseline, n=58, Stage 00
Baseline, n=58, Stage 19
Baseline, n=58, Stage 1.52
Baseline, n=58, Stage 221
Baseline, n=58, Stage 2.514
Baseline, n=58, Stage 312
Baseline, n=58, Stage 40
Baseline, n=58, Stage 50
Week 52, n=46, Stage 01
Week 52, n=46, Stage 112
Week 52, n=46, Stage 1.51
Week 52, n=46, Stage 214
Week 52, n=46, Stage 2.513
Week 52, n=46, Stage 35
Week 52, n=46, Stage 40
Week 52, n=46, Stage 50
FAP, n=58, Stage 01
FAP, n=58, Stage 113
FAP, n=58, Stage 1.52
FAP, n=58, Stage 217
FAP, n=58, Stage 2.518
FAP, n=58, Stage 37
FAP, n=58, Stage 40
FAP, n=58, Stage 50
SecondaryMean 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).

Time frame:
Baseline, Week 52, and FAP (up to Week 52)
Reported as:
Mean · percent change
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
percent changeROP+L-Dopa, "On" StateROP+L-Dopa, "Off" State (Only Participants With "Off" State)
Week 52, n=47, 133.4 ± 10.525.8 ± 16.31
FAP, n=63, 213.0 ± 9.972.6 ± 14.63
SecondaryMean 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).

Time frame:
Baseline, Week 52, and FAP (up to Week 52)
Reported as:
Mean · percent change
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
percent changeRopinirole Hydrochloride
Week 52, n=462.1 ± 6.74
FAP, n=581.5 ± 7.28
SecondaryPercentage 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.

Time frame:
Days 0-422
Reported as:
Number · percentage of participants
Percentage of Participants Remaining in the Study on the Indicated Days in the ROP+L-Dopa Group
percentage of participantsROP+L-Dopa
Day 0100
Day 2298
Day 3395
Day 4394
Day 8592
Day 10191
Day 11289
Day 12888
Day 15486
Day 16983
Day 19682
Day 20380
Day 23878
Day 28277
Day 30175
Day 34174
Day 36572
Day 42272
SecondaryPercentage 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.

Time frame:
Days 0-419
Reported as:
Number · percentage of participants
Percentage of Participants Remaining in the Study on the Indicated Days in the ROP Group
percentage of participantsRopinirole Hydrochloride
Day 0100
Day 1498
Day 2997
Day 3695
Day 6693
Day 7191
Day 8590
Day 16788
Day 16986
Day 17584
Day 21083
Day 24181
Day 25379
Day 41979
SecondaryNumber 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."

Time frame:
Week 52 and FAP (up to Week 52)
Reported as:
Number · participants
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale at Week 52 and FAP
participantsROP+L-DopaRopinirole Hydrochloride
Week 52, n=47, 463328
FAP, n=64, 583431
SecondaryMean 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.

Time frame:
Baseline, Week 52, and FAP (up to Week 52)
Reported as:
Mean · hours
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
hoursROP+L-Dopa, "Off" HoursROP+L-Dopa, "On" Hours
Week 52, n=16-0.09 ± 3.5021.00 ± 4.090
FAP, n=22-0.40 ± 3.4531.00 ± 3.867

Adverse events

Collected over From Baseline (Week 0) through the end of follow-up (up to Week 56).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ROP+L-Dopa—7/65 (10.8%)42/65 (64.6%)
Ropinirole Hydrochloride—3/58 (5.2%)43/58 (74.1%)
Most frequent serious events
Most frequent serious events
EventROP+L-DopaRopinirole Hydrochloride
CataractEye disorders0/651/58
DehydrationMetabolism and nutrition disorders0/651/58
Gastric cancer recurrentNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/651/58
Meniscus lesionInjury, poisoning and procedural complications1/650/58
Spinal compression fractureInjury, poisoning and procedural complications1/650/58
Parkinson's DiseaseNervous system disorders1/650/58
Sudden onset of sleepNervous system disorders1/650/58
VertigoEar and labyrinth disorders1/650/58
PyelonephritisInfections and infestations1/650/58
Back painMusculoskeletal and connective tissue disorders1/650/58
Most frequent other events
Showing 10 of 19
Most frequent other events
EventROP+L-DopaRopinirole Hydrochloride
NasopharyngitisInfections and infestations13/6519/58
SomnolenceNervous system disorders16/6514/58
Parkinson's DiseaseNervous system disorders7/650/58
NauseaGastrointestinal disorders7/654/58
ConstipationGastrointestinal disorders7/652/58
HallucinationPsychiatric disorders4/655/58
Orthostatic hypotensionVascular disorders3/655/58
DizzinessNervous system disorders0/654/58
Back painMusculoskeletal and connective tissue disorders4/654/58
HeadacheNervous system disorders4/653/58

Baseline characteristics

Age Continuous
Age Continuous(Years)ROP+L-DopaRopinirole HydrochlorideTotal
Mean66.0 ± 7.9465.5 ± 7.1865.8 ± 7.56
Sex: Female, Male
Sex: Female, Male(Participants)ROP+L-DopaRopinirole HydrochlorideTotal
Female273158
Male382765
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)ROP+L-DopaRopinirole HydrochlorideTotal
Asian - Japanese Heritage6558123
Other000
08

Study locations

22 sites
  • GSK Investigational Site
    Chiba, 270-2251, Japan
  • GSK Investigational Site
    Fukuoka, 814-0180, Japan
  • GSK Investigational Site
    Fukuoka, 816-0943, Japan
  • GSK Investigational Site
    Fukuoka, 819-8585, Japan
  • GSK Investigational Site
    Hyogo, 651-2273, Japan
  • GSK Investigational Site
    Ibaraki, 300-0053, Japan
  • GSK Investigational Site
    Iwate, 020-8505, Japan
  • GSK Investigational Site
    Kanagawa, 247-8533, Japan
  • GSK Investigational Site
    Kanagawa, 253-8558, Japan
  • GSK Investigational Site
    Kyoto, 616-8255, Japan
  • GSK Investigational Site
    Miyagi, 982-8555, Japan
  • GSK Investigational Site
    Miyagi, 989-2202, Japan
  • GSK Investigational Site
    Osaka, 543-8555, Japan
  • GSK Investigational Site
    Osaka, 558-8558, Japan
  • GSK Investigational Site
    Osaka, 578-8588, Japan
  • GSK Investigational Site
    Osaka, 590-0132, Japan
  • GSK Investigational Site
    Osaka, 598-0048, Japan
  • GSK Investigational Site
    Saga, 849-8501, Japan
  • GSK Investigational Site
    Saitama, 364-8501, Japan
  • GSK Investigational Site
    Tokyo, 154-8551, Japan
  • GSK Investigational Site
    Tokyo, 160-0017, Japan
  • GSK Investigational Site
    Tokyo, 187-8551, Japan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00485069
Lead sponsor
GlaxoSmithKline
First posted
Jun 12, 2007
Start date
Jun 2007
Primary completion
Dec 2009
Completion
Dec 2009
Results posted
Dec 15, 2010
Last update
Dec 15, 2010

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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