Last updated: 11/07/2018 01:21:47

Clinical Evaluation of ropinirole Prolonged release/extended release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in subjects with advanced Parkinson’s disease

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GSK study ID
106066
See study documents
Clinicaltrials.gov ID
NCT00823836
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: Clinical Evaluation of ropinirole PR/XR Tablet for Adjunctive Therapy to L-dopa in subjects with advanced Parkinson’s disease
Trial description: To investigate the efficacy and the safety of ropinirole PR/XR tablets to ropinirole immediate release (IR) tablets with advanced Parkinson’s disease in conjunction with L-dopa in a double-blind, parallel group comparison study.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Mean Change From Week 0 (Baseline) in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score at the Final Assessment Point (FAP) (up to Week 24) in the Non-Inferiority Verification Phase

Timeframe: Week 0 and FAP (up to Week 24)

Secondary outcomes:

Percentage of Responders on the Japanese UPDRS Part III Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase

Timeframe: FAP (up to Week 24)

Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase

Timeframe: Week 0 and FAP (up to Week 24)

Mean Change From Week 0 in the Japanese UPDRS Part II (at "On") Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase

Timeframe: Week 0 and FAP (up to Week 24)

Mean Change From Week 0 in the Japanese UPDRS Part II (at "Off") Total Score at Week 24 in the Non-Inferiority Verification Phase

Timeframe: Week 0 and FAP (up to Week 24)

Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase

Timeframe: Week 0 and FAP (up to Week 24)

Japanese UPDRS Part I Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase

Timeframe: Week 0 and FAP (up to Week 24)

Japanese UPDRS Part II (at "On") Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase

Timeframe: Week 0 and FAP (up to Week 24)

Japanese UPDRS Part II (at "Off") Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase

Timeframe: Week 0 and FAP (up to Week 24)

Japanese UPDRS Part III Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase

Timeframe: Week 0 and FAP (up to Week 24)

Japanese UPDRS Part IV Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase

Timeframe: Week 0 and FAP (up to Week 24)

Percentage of Responders on the Clinical Global Impression-Improvement (CGI-I) at FAP (up to Week 24) in the Non-Inferiority Verification Phase

Timeframe: FAP (up to Week 24)

Percentage of Responders in Change from Week 0 in Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase

Timeframe: FAP (up to Week 24)

Percentage of Responders in Percent Change from Week 0 in Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase

Timeframe: FAP (up to Week 24)

Mean Change From Week 0 in Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase

Timeframe: Week 0 and FAP (up to Week 24)

Mean Change From Week 0 in Percentage of Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase

Timeframe: Week 0 and FAP (up to Week 24)

Mean Percent Change From Week 0 in Percentage of Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase

Timeframe: Week 0 and FAP (up to Week 24)

Mean Change From Week 0 in Awake Time Spent "On" at FAP (up to Week 24) in the Non-Inferiority Verification Phase

Timeframe: Week 0 and FAP (up to Week 24)

Mean Change From Week 0 in Percentage of Awake Time Spent “On” at FAP (up to Week 24) in the Non-Inferiority Verification Phase

Timeframe: Week 0 and FAP (up to Week 24)

Mean Change From Week 0 in Awake Time Spent "On" With Troublesome Dyskinesias at FAP (up to Week 24) in the Non-Inferiority Verification Phase

Timeframe: Week 0 and FAP (up to Week 24)

Mean Change From Week 0 in Percentage of Awake Time Spent "On" With Troublesome Dyskinesias at FAP (up to Week 24) in the Non-Inferiority Verification Phase

Timeframe: Week 0 and FAP (up to Week 24)

Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase

Timeframe: Week 0 and FAP (up to Week 24)

Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase

Timeframe: Week 0 and FAP (up to Week 24)

Percentage of Participants Remaining in the Study on the Indicated Days during the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: 0-175 days (up to Week 24)

Percentage of Participants Remaining in the Study on the Indicated Days during the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group

Timeframe: 0-175 days (up to Week 24)

Mean Change From Week 24 (Period Baseline) in the Japanese UPDRS Part I Total Score at FAP (from Week 26 up to Week 32) in the PR/XR Switching Phase

Timeframe: Week 24 and FAP (from Week 26 up to Week 32)

Mean Change From Week 24 in the Japanese UPDRS Part II (at "On") Total Score at FAP (from Week 26 up to Week 32) in the PR/XR Switching Phase

Timeframe: Week 24 and FAP (from Week 26 up to Week 32)

Mean Change From Week 24 in the Japanese UPDRS Part II (at "Off") Total Score at FAP (from Week 26 up to Week 32) in the PR/XR Switching Phase

Timeframe: Week 24 and FAP (from Week 26 up to Week 32)

Mean Change From Week 24 in the Japanese UPDRS Part III Total Score at FAP (from Week 26 up to Week 32) in the PR/XR Switching Phase

Timeframe: Week 24 and FAP (from Week 26 up to Week 32)

Mean Change From Week 24 in the Japanese UPDRS Part IV Total Score at FAP (from Week 26 up to Week 32) in the PR/XR Switching Phase

Timeframe: Week 24 and FAP (from Week 26 up to Week 32)

Japanese UPDRS Part I Total Score at Week 24 and FAP (from Week 26 up to Week 32) in the PR/XR Switching Phase

Timeframe: Week 24 and FAP (from Week 26 up to Week 32)

Japanese UPDRS Part II (at "On") Total Score at Week 24 and FAP (from Week 26 up to Week 32) in the PR/XR Switching Phase

Timeframe: Week 24 and FAP (from Week 26 up to Week 32)

Japanese UPDRS Part II (at "Off") Total Score at Week 24 and FAP (from Week 26 up to Week 32) in the PR/XR Switching Phase

Timeframe: Week 24 and FAP (from Week 26 up to Week 32)

Japanese UPDRS Part III Total Score at Week 24 and FAP (from Week 26 up to Week 32) in the PR/XR Switching Phase

Timeframe: Week 24 and FAP (from Week 26 up to Week 32)

Japanese UPDRS Part IV Total Score at Week 24 and FAP (from Week 26 up to Week 32) in the PR/XR Switching Phase

Timeframe: Week 24 and FAP (from Week 26 up to Week 32)

Mean Change From Week 24 in Awake Time Spent “Off” at FAP (from Week 26 up to Week 32) in the PR/XR Switching Phase

Timeframe: Week 24 and FAP (from Week 26 up to Week 32)

Mean Change From Week 24 in Percentage of Awake Time Spent “Off” at FAP (from Week 26 up to Week 32) in the PR/XR Switching Phase

Timeframe: Week 24 and FAP (from Week 26 up to Week 32)

Mean Change From Week 24 in Awake Time Spent “On” With Troublesome Dyskinesias at FAP (from Week 26 up to Week 32) in the PR/XR Switching Phase

Timeframe: Week 24 and FAP (from Week 26 up to Week 32)

Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (from Week 26 up to Week 32) in the PR/XR Switching Phase

Timeframe: Week 24 and FAP (from Week 26 up to Week 32)

Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (from Week 26 up to Week 32) in the PR/XR Switching Phase

Timeframe: Week 24 and FAP (from Week 26 up to Week 32)

Percentage of Participants Remaining in the Study on the Indicated Days during the PR/XR Switching Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: 0-89 days within the PR/XR Switching Phase (between Weeks 24 and 32)

Percentage of Participants Remaining in the Study on the Indicated Days during the PR/XR Switching Phase in the Ropinirole IR-Ropinirole PR Group

Timeframe: 0-89 days within the PR/XR Switching Phase (between Weeks 24 and 32)

Percentage of Responders on the Japanese UPDRS Part III Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: Week 54

Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: Weeks 0 and 54

Mean Change From Week 0 in the Japanese UPDRS Part II (at "On") Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: Weeks 0 and 54

Mean Change From Week 0 in the Japanese UPDRS Part II (at "Off") Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: Weeks 0 and 54

Mean Change From Week 0 in the Japanese UPDRS Part III Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: Weeks 0 and 54

Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: Weeks 0 and 54

Japanese UPDRS Part I Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: Weeks 0 and 54

Japanese UPDRS Part II (at "On") Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: Weeks 0 and 54

Japanese UPDRS Part II (at "Off") Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: Weeks 0 and 54

Japanese UPDRS Part III Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: Weeks 0 and 54

Japanese UPDRS Part IV Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: Weeks 0 and 54

Percentage of Responders on the CGI-I at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: Week 54

Percentage of Responders in Change from Week 0 in Awake Time Spent "Off" at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: Week 54

Percentage of Responders in Percent Change from Week 0 in Awake Time Spent "Off" at Week 54 in the Long-term Phase

Timeframe: Week 54

Mean Change From Week 0 in Awake Time Spent “Off” at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: Weeks 0 and 54

Mean Change From Week 0 in Percentage of Awake Time Spent “Off” at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: Weeks 0 and 54

Mean Change From Week 0 in Awake Time Spent “On” With Troublesome Dyskinesias at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: Weeks 0 and 54

Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: Weeks 0 and 54

Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: Weeks 0 and 54

Percentage of Participants Remaining in the Study on the Indicated Days during the Long-term Phase in the Ropinirole PR-Ropinirole PR Group

Timeframe: 0-385 days (up to Week 54)

Interventions:
  • Drug: ropinirole PR/XR
  • Drug: ropinirole IR
    • Enrollment:
    302
    Primary completion date:
    2010-21-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Parkinson Disease
    Product
    ropinirole
    Collaborators
    Not applicable
    Study date(s)
    March 2009 to December 2010
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    20+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria at the start of the screening
    • Patients who are diagnosed with advanced Parkinson’s disease (PD) with severity of the modified Hoehn & Yahr criteria Stages II-IV.
    • Late stage advanced subjects demonstrating incapacitating peak dose or biphasic dyskinesia on their stable dose of L-dopa.
    • Patients who present serious physical signs and symptoms other than those of the PD (e.g. cardiac/hepatic/renal disorder and haematopoietic disorder). The severity refers to Grade 3 according to "the Classification of the Severity of Adverse Experiences (Pharmaceutical affairs bureau/Safety division (PAB/SD) Notification No. 80, dated 29 June 1992).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria at the start of the screening -Patients who are diagnosed with advanced Parkinson’s disease (PD) with severity of the modified Hoehn & Yahr criteria Stages II-IV. -Subjects receiving a stable dose of L-dopa for at least 4 weeks prior to screening phase and demonstrating lack of control with L-dopa therapy in the following circumstances. Wearing-off phenomena. On-off fluctuations. Delayed-on/No on phenomena. Not adequately controlled on L-dopa -QTc<450 millisecond (msec) or <480msec for patients with Bundle Branch Block – values based on either single ECG values or triplicate electrocardiogram (ECG) averaged QTc values obtained over a brief recording period. -Age:20 years or older(at the time of informed written consent) -Informed consent: Patients who are able to give informed written consent in person. (i.e. patients who are capable of giving informed written consent on one’s own) -Sex: either sex. Female of child-bearing potential will be eligible for inclusion in this study. However they have to have a negative pregnancy test at the screening visit, agree to further pregnancy testing at the time points determined in study assessments and procedures and practice one of the following methods of contraception from the screening visit until the end of the follow-up examination. Abstinence. Injectable progestogen. Implants of levonorgestrel. Estrogenic vaginal ring. Percutaneous contraceptive patches. Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label. Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. Double barrier method: condom or occlusive cap (diaphragm or cervical / vault caps) plus spermicidal agent (foam /gel / film / cream / suppository) -Both inpatient and outpatient status. Inclusion Criteria at the start of the non-inferiority verification phase -Patients whose Unified Parkinson's Disease Rating Scale (UPDRS) PartIII total (on) scores is 10 points or more at week 0.
    Exclusion criteria:
    • Late stage advanced subjects demonstrating incapacitating peak dose or biphasic dyskinesia on their stable dose of L-dopa. -Patients who present serious physical signs and symptoms other than those of the PD (e.g. cardiac/hepatic/renal disorder and haematopoietic disorder). The severity refers to Grade 3 according to "the Classification of the Severity of Adverse Experiences (Pharmaceutical affairs bureau/Safety division (PAB/SD) Notification No. 80, dated 29 June 1992). -Patients with symptomatic postural hypotension. (e.g. dizziness and syncope). -Patients with a current or history of drug abuse or alcoholism. -Patients who have received surgical treatment for PD in the past (e.g. pallidectomy, deep brain stimulation). -Female patients who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study or within 30 days after the last dose of the study drug. -Patients with chronic hepatitis typeB and/or type C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody. -Patients with a history of drug allergy to ropinirole hydrochloride (HCl). -Patients with a current or history of cancer or malignant tumor. -Others whom the investigator (subinvestigator) considers ineligible for the study. Exclusion criteria at the start of the non-inferiority verification phase -Patients with severe dementia (e.g. score 3 or 4 of the UPDRS item 1 (Intellectual Impairment)) -Patients with current or history of major psychosis (e.g. schizophrenia or psychotic depression) core 3 or 4 of the UPDRS item 2 (thought disorder) or item 3(depression). -Patients who have used any dopamine agonist within 4 weeks prior to the non-inferiority verification phase -Patients who have been treated with the following drugs at 4 weeks or earlier before the start of the non-inferiority verification phase, and whose treatment regimen of the drug has been changed. Anticholinergic agents: trihexyphenidyl hydrochloride (e.g. Artane®), piroheptine hydrochloride (Trimol®), mazaticol hydrochloride (Pentona®), metixene hydrochloride (Cholinfall®), biperiden hydrochloride (Akineton®), profenamine (Parkin®), amantadine hydrochloride (e.g. Symmetrel®),droxidopa (Dops®), citicoline (e.g. Nicholin®), selegiline hydrochloride (FP®), entacapone, (comutan®) zonisamide, Estrogens: e.g. estriol (e.g. Estriel®), CYP1A2 inhibitors: Ciprofloxacin HCl (e.g. Ciproxan®, enoxacin and fluvoxamine). -Patients who have been treated with any other investigational drug within 12 weeks prior to the treatment phase.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Shizuoka, Japan, 420-8688
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kanagawa, Japan, 251-0038
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fukuoka, Japan, 819-8585
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fukuoka, Japan, 816-0864
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kyoto, Japan, 601-1495
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Osaka, Japan, 598-0048
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 53 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
    2010-21-12
    Actual study completion date
    2010-21-12

    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.

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