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Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Ropinirole prolonged release/extended release(PR/XR)
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's Disease, PD

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are diagnosed with PD with severity of the Modified Hoehn & Yahr staging at Stage I to III.
  • Age: 20 years or older (at the time of giving informed consent)
  • Gender: male and female
  • Both inpatient and outpatient status
  • 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)
  • Limited prior exposure to low or moderate doses of L-dopa (up to 3 months in total) or dopamine agonists (up to 6 months in total) provided treatment is discontinued for a minimum of 4 weeks prior to screening.

Exclusion Criteria:

  • Patients who present serious physical signs and symptoms other than those of the PD (e.g. cardiac/hepatic/renal disorder and haematopoietic disorder). The seriousness 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 who have had serious psychiatric symptoms (e.g. confusion, hallucination, delusion, abnormal behaviour, alcohol or drug dependence) during the past six months (26 weeks) (including symptoms caused by anti-Parkinson drugs).

  • Patients who have been treated with the following drugs at Week -4, and whose treatment regimen of the drug has been changed from Week -4 to Week 0.

    • 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®)
    • zonisamide
    • estrogen: estriol (e.g.Estriel®)
    • CYP1A2 inhibitors: Ciprofloxacin HCl (e.g. Ciproxan®, enoxacin and fluvoxamine)
  • Patients with severe dementia such as score 3 or 4 of the UPDRS Part I (Mentation, behaviour, and mood)
  • 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 current history or complication of carcinoma or malignant tumour.
  • Patients who have history of drug allergy to ropinirole hydrochloride (HCl).
  • 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 drug within 12weeks prior to the treatment phase.
  • Others whom the investigator (sub investigator) considers ineligible for the study.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ropinirole PR/XR

Arm Description

Outcomes

Primary Outcome Measures

Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites
The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Cmax: maximum concentration, Cmin: trough plasma concentration.
Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites
The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours (hr) post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. AUC0-24: area under the drug concentration 24 hr curve.
Food Effects on Tmax of SKF101468 (Ropinirole) and Its Metabolites
The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Tmax: time of maximum concentration. Data are presented as the median difference between fed and fasted states for ropinirole and each metabolite.
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites
Blood sampling in the fixed titration phase will be performed at 24 hour post dose of the last dose of 2, 4, and 8 mg (immediately before the morning dose). Blood sampling in the maintenance dose phase will be performed at 24 hour post dose of 10 mg or more for one week or longer (immediately before the morning dose), as sampling needs to be conducted at steady state.

Secondary Outcome Measures

Total Score in the Japanese UPDRS Part III
The Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.
Change From Baseline in the Japanese UPDRS Part III
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.
Percent Change From Baseline in the Japanese UPDRS Part III
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. A maximum total score is 108 points.The higher score indicates more severe PD symptoms.
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III
A responder is defined as a participant with a 30% or more reduction at baseline. The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.
Total Score in the Japanese UPDRS Part I
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.
Change From Baseline in the Japanese UPDRS Part I
The UPDRS (Unified Parkinson's Disease Rating Scale) assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.
Percent Change From Baseline in the Japanese UPDRS Part I
The UPDRS (Unified Parkinson's Disease Rating Scale) assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.
Total Score in the Japanese UPDRS Part II
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.
Change From Baseline in the Japanese UPDRS Part II
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.
Percent Change From Baseline in the Japanese UPDRS Part II
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.
Total Score in the Japanese UPDRS Part IV
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.
Change From Baseline in the Japanese UPDRS Part IV
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each 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 in the Japanese UPDRS Part IV
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.
Summary of the Modified Hoehn & Yahr Criteria Stages
Hoehn & Yahr criteria were measured on an 8-point scale. 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. No subjects evaluated had a score of 4 (severe disability) or 5 (wheelchair bound or bedridden unless aided).
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale
CGI is measured on a 7-point scale. 1: Very much improved, 2: Much Improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Responders are defined as those participants scored as "very much improved" or "much improved."
Percentage of Participants Who Remained in the Study on the Indicated Days
The percentage of participants remaining in the study was examined using the Kaplan-Meier method, in which a premature discontinuation will be considered as an event.
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Change From Baseline in Prolactin at Weeks 16 and 52
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Change From Baseline in Hematocrit at Weeks 16 and 52
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Change From Baseline in Red Blood Cell Count at Weeks 16 and 52
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Urinalysis Data
The number of participants with the indicated dipstick test values were measured. Dipstick test values: Neg Value, Trace, +1, +2, +3, +4. No participants had a score of +5.
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52
Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS.
Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52
Change from baseline was calculated as Week 16 and Week 52 values minus baseline values.
Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52
Change from baseline was calculated as Week 16 and Week 52 values minus baseline values.

Full Information

First Posted
February 9, 2007
Last Updated
August 30, 2018
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00434304
Brief Title
Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)
Official Title
Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease - an Open-Label, Uncontrolled Study -
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 9, 2007 (undefined)
Primary Completion Date
March 1, 2009 (Actual)
Study Completion Date
March 10, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
This study was designed to evaluate the pharmacokinetic profile, safety and efficacy in Parkinson's Disease patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's Disease, PD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropinirole PR/XR
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ropinirole prolonged release/extended release(PR/XR)
Intervention Description
Subjects will take the investigational drug once daily at the same time each day, it is recommended that this is in the morning for optimal benefit. Investigational drug is taken for 52 weeks, starting on the next day of the Week 0 visit. One tablet of ropinirole PR/XR 2 mg tablets will be orally dosed as the initial dose. The dose will be titrated weekly by 2 mg/day, and increased to 8 mg/day in Week 4. From Week 5 up to 16, the dose will be increased at minimum intervals of one week between titration steps until sufficient efficacy is obtained, according to individual clinical response and tolerability (the dose may be titrated up to 16 mg/day). In Week 16 and further, treatment dose at Week 16 will be continuously administered up to Week 52. If insufficient efficacy is judged in a subject during treatment, or unable to maintain the dose due to adverse event, the treatment dose may be changed. The dose is down tapered according to the maintenance dose at Week 52 (or withdrawal).
Primary Outcome Measure Information:
Title
Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites
Description
The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Cmax: maximum concentration, Cmin: trough plasma concentration.
Time Frame
Weeks 5-16
Title
Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites
Description
The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours (hr) post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. AUC0-24: area under the drug concentration 24 hr curve.
Time Frame
Weeks 5-16
Title
Food Effects on Tmax of SKF101468 (Ropinirole) and Its Metabolites
Description
The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Tmax: time of maximum concentration. Data are presented as the median difference between fed and fasted states for ropinirole and each metabolite.
Time Frame
Weeks 5-16
Title
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites
Description
Blood sampling in the fixed titration phase will be performed at 24 hour post dose of the last dose of 2, 4, and 8 mg (immediately before the morning dose). Blood sampling in the maintenance dose phase will be performed at 24 hour post dose of 10 mg or more for one week or longer (immediately before the morning dose), as sampling needs to be conducted at steady state.
Time Frame
Weeks 1-16
Secondary Outcome Measure Information:
Title
Total Score in the Japanese UPDRS Part III
Description
The Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.
Time Frame
Weeks 0-52
Title
Change From Baseline in the Japanese UPDRS Part III
Description
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.
Time Frame
Baseline (Week 0) and Weeks 1-52
Title
Percent Change From Baseline in the Japanese UPDRS Part III
Description
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. A maximum total score is 108 points.The higher score indicates more severe PD symptoms.
Time Frame
Baseline (Week 0) and Weeks 1-52
Title
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III
Description
A responder is defined as a participant with a 30% or more reduction at baseline. The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.
Time Frame
Baseline (Week 0) and Weeks 1-52
Title
Total Score in the Japanese UPDRS Part I
Description
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.
Time Frame
Weeks 0-52
Title
Change From Baseline in the Japanese UPDRS Part I
Description
The UPDRS (Unified Parkinson's Disease Rating Scale) assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.
Time Frame
Baseline (Week 0) and Weeks 1-52
Title
Percent Change From Baseline in the Japanese UPDRS Part I
Description
The UPDRS (Unified Parkinson's Disease Rating Scale) assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.
Time Frame
Baseline (Week 0) and Weeks 1-52
Title
Total Score in the Japanese UPDRS Part II
Description
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.
Time Frame
Weeks 0-52
Title
Change From Baseline in the Japanese UPDRS Part II
Description
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.
Time Frame
Baseline (Week 0) and Weeks 1-52
Title
Percent Change From Baseline in the Japanese UPDRS Part II
Description
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.
Time Frame
Baseline (Week 0) and Weeks 1-52
Title
Total Score in the Japanese UPDRS Part IV
Description
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each 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 0) and Weeks 0-52
Title
Change From Baseline in the Japanese UPDRS Part IV
Description
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each 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 0) and Weeks 1-52
Title
Percent Change From Baseline in the Japanese UPDRS Part IV
Description
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each 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 0) and Weeks 1-52
Title
Summary of the Modified Hoehn & Yahr Criteria Stages
Description
Hoehn & Yahr criteria were measured on an 8-point scale. 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. No subjects evaluated had a score of 4 (severe disability) or 5 (wheelchair bound or bedridden unless aided).
Time Frame
Screening-Week 52
Title
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale
Description
CGI is measured on a 7-point scale. 1: Very much improved, 2: Much Improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Responders are defined as those participants scored as "very much improved" or "much improved."
Time Frame
Weeks 1-52
Title
Percentage of Participants Who Remained in the Study on the Indicated Days
Description
The percentage of participants remaining in the study was examined using the Kaplan-Meier method, in which a premature discontinuation will be considered as an event.
Time Frame
Days 0-364
Title
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52
Description
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Time Frame
Baseline (Screening) and Weeks 16 and 52
Title
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52
Description
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Time Frame
Baseline (Screening) and Weeks 16 and 52
Title
Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52
Description
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Time Frame
Baseline (Screening) and Weeks 16 and 52
Title
Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52
Description
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Time Frame
Baseline (Screening) and Weeks 16 and 52
Title
Change From Baseline in Prolactin at Weeks 16 and 52
Description
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Time Frame
Baseline (Screening) and Weeks 16 and 52
Title
Change From Baseline in Hematocrit at Weeks 16 and 52
Description
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Time Frame
Baseline (Screening) and Weeks 16 and 52
Title
Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52
Description
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Time Frame
Baseline (Screening) and Weeks 16 and 52
Title
Change From Baseline in Red Blood Cell Count at Weeks 16 and 52
Description
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Time Frame
Baseline (Screening) and Weeks 16 and 52
Title
Urinalysis Data
Description
The number of participants with the indicated dipstick test values were measured. Dipstick test values: Neg Value, Trace, +1, +2, +3, +4. No participants had a score of +5.
Time Frame
Screening, Week 16, and Week 52
Title
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52
Description
Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS.
Time Frame
Baseline (Screening) and Weeks 16 and 52
Title
Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52
Description
Change from baseline was calculated as Week 16 and Week 52 values minus baseline values.
Time Frame
Baseline (Screening) and Weeks 16 and 52
Title
Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52
Description
Change from baseline was calculated as Week 16 and Week 52 values minus baseline values.
Time Frame
Baseline (Screening) and Weeks 16 and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are diagnosed with PD with severity of the Modified Hoehn & Yahr staging at Stage I to III. Age: 20 years or older (at the time of giving informed consent) Gender: male and female Both inpatient and outpatient status 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) Limited prior exposure to low or moderate doses of L-dopa (up to 3 months in total) or dopamine agonists (up to 6 months in total) provided treatment is discontinued for a minimum of 4 weeks prior to screening. Exclusion Criteria: Patients who present serious physical signs and symptoms other than those of the PD (e.g. cardiac/hepatic/renal disorder and haematopoietic disorder). The seriousness 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 who have had serious psychiatric symptoms (e.g. confusion, hallucination, delusion, abnormal behaviour, alcohol or drug dependence) during the past six months (26 weeks) (including symptoms caused by anti-Parkinson drugs). Patients who have been treated with the following drugs at Week -4, and whose treatment regimen of the drug has been changed from Week -4 to Week 0. 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®) zonisamide estrogen: estriol (e.g.Estriel®) CYP1A2 inhibitors: Ciprofloxacin HCl (e.g. Ciproxan®, enoxacin and fluvoxamine) Patients with severe dementia such as score 3 or 4 of the UPDRS Part I (Mentation, behaviour, and mood) 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 current history or complication of carcinoma or malignant tumour. Patients who have history of drug allergy to ropinirole hydrochloride (HCl). 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 drug within 12weeks prior to the treatment phase. Others whom the investigator (sub investigator) considers ineligible for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Aichi
ZIP/Postal Code
455-8530
Country
Japan
Facility Name
GSK Investigational Site
City
Aichi
ZIP/Postal Code
460-0008
Country
Japan
Facility Name
GSK Investigational Site
City
Chiba
ZIP/Postal Code
279-0021
Country
Japan
Facility Name
GSK Investigational Site
City
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
070-0901
Country
Japan
Facility Name
GSK Investigational Site
City
Iwate
ZIP/Postal Code
020-0878
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
251-0038
Country
Japan
Facility Name
GSK Investigational Site
City
Kyoto
ZIP/Postal Code
600-8811
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
570-8507
Country
Japan
Facility Name
GSK Investigational Site
City
Saitama
ZIP/Postal Code
343-0032
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
136-0075
Country
Japan

12. IPD Sharing Statement

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Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)

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