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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2010-21-12
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
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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
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Location
GSK Investigational Site
Kyoto, Japan, 601-1495
Status
Study Complete
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Location
GSK Investigational Site
Osaka, Japan, 598-0048
Status
Study Complete
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Location
GSK Investigational Site
Hyogo, Japan, 674-0081
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
Ehime, Japan, 791-0295
Status
Study Complete
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Location
GSK Investigational Site
Chiba, Japan, 270-1337
Status
Study Complete
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Location
GSK Investigational Site
Hyogo, Japan, 670-0981
Status
Study Complete
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Location
GSK Investigational Site
Chiba, Japan, 260-8712
Status
Study Complete
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Location
GSK Investigational Site
Osaka, Japan, 590-0132
Status
Study Complete
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Location
GSK Investigational Site
Nara, Japan, 632-8552
Status
Study Complete
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Location
GSK Investigational Site
Nagano, Japan, 399-8695
Status
Study Complete
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Location
GSK Investigational Site
Nagasaki, Japan, 859-3615
Status
Study Complete
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Location
GSK Investigational Site
Fukuoka, Japan, 800-0296
Status
Study Complete
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Location
GSK Investigational Site
Akita, Japan, 010-0874
Status
Study Complete
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Location
GSK Investigational Site
Osaka, Japan, 560-8552
Status
Study Complete
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Location
GSK Investigational Site
Fukushima, Japan, 963-8052
Status
Study Complete
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Location
GSK Investigational Site
Fukuoka, Japan, 814-0180
Status
Study Complete
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Location
GSK Investigational Site
Osaka, Japan, 578-8588
Status
Study Complete
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Location
GSK Investigational Site
Kanagawa, Japan, 247-8533
Status
Study Complete
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Location
GSK Investigational Site
Tochigi, Japan, 329-0498
Status
Study Complete
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Location
GSK Investigational Site
Saitama, Japan, 359-1141
Status
Study Complete
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Location
GSK Investigational Site
Saitama, Japan, 343-0032
Status
Study Complete
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Location
GSK Investigational Site
Kyoto, Japan, 600-8811
Status
Study Complete
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Location
GSK Investigational Site
Shizuoka, Japan, 416-0955
Status
Study Complete
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Location
GSK Investigational Site
Kanagawa, Japan, 232-0066
Status
Study Complete
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Location
GSK Investigational Site
Chiba, Japan, 290-0003
Status
Study Complete
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Location
GSK Investigational Site
Tokyo, Japan, 136-0075
Status
Study Complete
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Location
GSK Investigational Site
Hokkaido, Japan, 068-0027
Status
Study Complete
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Location
GSK Investigational Site
Tokyo, Japan, 113-8431
Status
Study Complete
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Location
GSK Investigational Site
Aichi, Japan, 454-0933
Status
Study Complete
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Location
GSK Investigational Site
Osaka, Japan, 596-8522
Status
Study Complete
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Location
GSK Investigational Site
Tokyo, Japan, 202-0004
Status
Study Complete
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Location
GSK Investigational Site
Nagano, Japan, 399-0157
Status
Study Complete
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Location
GSK Investigational Site
Okayama, Japan, 703-8265
Status
Study Complete
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Location
GSK Investigational Site
Miyagi, Japan, 983-8520
Status
Study Complete
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Location
GSK Investigational Site
Osaka, Japan, 530-8480
Status
Study Complete
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Location
GSK Investigational Site
Kanagawa, Japan, 252-0392
Status
Study Complete
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Location
GSK Investigational Site
Kyoto, Japan, 610-0113
Status
Study Complete
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Location
GSK Investigational Site
Kanagawa, Japan, 253-8558
Status
Study Complete
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Location
GSK Investigational Site
Kyoto, Japan, 616-8255
Status
Study Complete
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Location
GSK Investigational Site
Tokyo, Japan, 183-8524
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
Shiga, Japan, 524-0022
Status
Study Complete
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Location
GSK Investigational Site
Aichi, Japan, 465-8620
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
Chiba, Japan, 279-0021
Status
Study Complete
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Location
GSK Investigational Site
Ibaraki, Japan, 310-0011
Status
Study Complete
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Location
GSK Investigational Site
Aichi, Japan, 460-0008
Status
Study Complete
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Location
GSK Investigational Site
Aichi, Japan, 489-8642
Status
Study Complete
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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
Completed
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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