Last updated: 11/03/2018 10:08:20

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

GSK study ID
108862
See study documents
Clinicaltrials.gov ID
NCT00485069
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Post-Marketing Clinical Study of REQUIP (Ropinirole Hydrochloride) Tablets in Patients with Parkinson's Disease- Evaluation of Long-Term Efficacy and Safety -
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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)

Timeframe: Baseline, Week 52, and FAP (up to Week 52)

Secondary outcomes:

Mean Change from Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Baseline, Week 52, and FAP (up to Week 52)

Japanese UPDRS Part I Mean Total Score at Baseline, Week 52, and FAP

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Baseline, Week 52, and FAP (up to Week 52)

Japanese UPDRS Part IV Mean Total Score at Baseline, Week 52, and FAP

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Days 0-422

Percentage of Participants Remaining in the Study on the Indicated Days in the ROP Group

Timeframe: Days 0-419

Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale at Week 52 and FAP

Timeframe: 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

Timeframe: Baseline, Week 52, and FAP (up to Week 52)

Interventions:
  • Drug: ROP
  • Drug: ROP+L-Dopa
    • Enrollment:
    123
    Primary completion date:
    2009-08-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Fumihito Yoshii, Hidekatsu Motoyama. Efficacy and safety of long-term and high-dose treatment with ropinirole in Japanese patients with Parkinson's disease (LEAD-PD study). [Ther Res]. 2011;32(8):1033-1046.
    Medical condition
    Parkinson Disease
    Product
    ropinirole
    Collaborators
    Not applicable
    Study date(s)
    June 2007 to December 2009
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    20+ years
    Accepts healthy volunteers
    No
    • 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.
    • 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).
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Miyagi, Japan, 989-2202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tokyo, Japan, 187-8551
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chiba, Japan, 270-2251
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Osaka, Japan, 543-8555
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hyogo, Japan, 651-2273
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Saga, Japan, 849-8501
    Status
    Study Complete
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    Showing 1 - 6 of 22 Results

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2009-08-12
    Actual study completion date
    2009-08-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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