Parkinson DiseasePhase 2NCT00434304

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

A Phase 2 study testing Ropinirole prolonged release/extended release(PR/XR) in people with Parkinson Disease, run by GlaxoSmithKline at 12 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study was designed to evaluate the pharmacokinetic profile, safety and efficacy in Parkinson's Disease patients. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Parkinson Disease
What is being tested?: Ropinirole prolonged release/extended release(PR/XR)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 12 sitesJapan
Study dates: 9 Apr 2007to 10 Mar 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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®)

Show all 19Show fewer

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.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Japan12 sites

GSK Investigational Site
Aichi, 455-8530
GSK Investigational Site
Aichi, 460-0008
GSK Investigational Site
Chiba, 279-0021
GSK Investigational Site
Ehime, 791-0295
GSK Investigational Site
Hokkaido, 070-0901
GSK Investigational Site
Kanagawa, 251-0038
GSK Investigational Site
Kyoto, 600-8811
GSK Investigational Site
Numakunai, 020-0878
GSK Investigational Site
Osaka, 570-8507
GSK Investigational Site
Saitama, 343-0032
GSK Investigational Site
Tokyo, 113-8431
GSK Investigational Site
Tokyo, 136-0075

Other trials in Japan

About this study

Official title: Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease - an Open-Label, Uncontrolled Study -

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

Conditions: Parkinson Disease
Being tested: Ropinirole prolonged release/extended release(PR/XR)
Keywords: Parkinson's Disease, PD
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ropinirole prolonged release/extended release(PR/XR)Drug
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).

Study groups in NCT00434304
Study group	Role	What they receive
Ropinirole PR/XR	Experimental	Not described Receives: Drug: Ropinirole prolonged release/extended release(PR/XR)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Weeks 5-16
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.
Measured: Weeks 5-16
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.
Measured: Weeks 5-16
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.
Measured: Weeks 1-16

Secondary outcomes (28)

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.
Measured: Weeks 0-52
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.
Measured: Baseline (Week 0) and Weeks 1-52
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.
Measured: Baseline (Week 0) and Weeks 1-52
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.
Measured: Baseline (Week 0) and Weeks 1-52
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.
Measured: Weeks 0-52
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.
Measured: Baseline (Week 0) and Weeks 1-52
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.
Measured: Baseline (Week 0) and Weeks 1-52
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.
Measured: Weeks 0-52
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.
Measured: Baseline (Week 0) and Weeks 1-52
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.
Measured: Baseline (Week 0) and Weeks 1-52
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.
Measured: Baseline (Week 0) and Weeks 0-52
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.
Measured: Baseline (Week 0) and Weeks 1-52
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.
Measured: Baseline (Week 0) and Weeks 1-52
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).
Measured: Screening-Week 52
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."
Measured: Weeks 1-52
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.
Measured: Days 0-364
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.
Measured: Baseline (Screening) and Weeks 16 and 52
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.
Measured: Baseline (Screening) and Weeks 16 and 52
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.
Measured: Baseline (Screening) and Weeks 16 and 52
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.
Measured: Baseline (Screening) and Weeks 16 and 52
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.
Measured: Baseline (Screening) and Weeks 16 and 52
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.
Measured: Baseline (Screening) and Weeks 16 and 52
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.
Measured: Baseline (Screening) and Weeks 16 and 52
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.
Measured: Baseline (Screening) and Weeks 16 and 52
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.
Measured: Screening, Week 16, and Week 52
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.
Measured: Baseline (Screening) and Weeks 16 and 52
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.
Measured: Baseline (Screening) and Weeks 16 and 52
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.
Measured: Baseline (Screening) and Weeks 16 and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Apr 200710 Mar 2009

First posted13 Feb 2007 (estimated)
Study start9 Apr 2007
Primary completion1 Mar 2009
Study completion10 Mar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00434304
Sponsor's protocol ID: ROP106064
Status last verified: Aug 2018
First submitted: 9 Feb 2007
Last updated: 27 Sep 2018
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease - an Open-Label, Uncontrolled Study -
ClinicalTrials.gov ID: NCT00434304
Acronym / sponsor ID: ROP106064
Conditions: Parkinson Disease
Keywords: Parkinson's Disease, PD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 9 Apr 2007
Primary completion: 1 Mar 2009 (actual)
Study completion: 10 Mar 2009 (actual)
First posted: 13 Feb 2007 (estimated)
Results: Posted 23 Dec 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ropinirole PR/XR	Experimental	Drug: Ropinirole prolonged release/extended release(PR/XR)

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (19 listed)

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.
Patients with severe dementia such as score 3 or 4 of the UPDRS Part I (Mentation, behaviour, and mood)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ropinirole prolonged release/extended release(PR/XR)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).	Drug	Ropinirole PR/XR

Primary outcome

Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites
Time frame: Weeks 5-16
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
Time frame: Weeks 5-16
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
Time frame: Weeks 5-16
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
Time frame: Weeks 1-16
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.

28 secondary outcomes

Total Score in the Japanese UPDRS Part III
Time frame: Weeks 0-52
Change From Baseline in the Japanese UPDRS Part III
Time frame: Baseline (Week 0) and Weeks 1-52
Percent Change From Baseline in the Japanese UPDRS Part III
Time frame: Baseline (Week 0) and Weeks 1-52
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III
Time frame: Baseline (Week 0) and Weeks 1-52
Total Score in the Japanese UPDRS Part I
Time frame: Weeks 0-52
Change From Baseline in the Japanese UPDRS Part I
Time frame: Baseline (Week 0) and Weeks 1-52
Percent Change From Baseline in the Japanese UPDRS Part I
Time frame: Baseline (Week 0) and Weeks 1-52
Total Score in the Japanese UPDRS Part II
Time frame: Weeks 0-52
Change From Baseline in the Japanese UPDRS Part II
Time frame: Baseline (Week 0) and Weeks 1-52
Percent Change From Baseline in the Japanese UPDRS Part II
Time frame: Baseline (Week 0) and Weeks 1-52
Total Score in the Japanese UPDRS Part IV
Time frame: Baseline (Week 0) and Weeks 0-52
Change From Baseline in the Japanese UPDRS Part IV
Time frame: Baseline (Week 0) and Weeks 1-52
Percent Change From Baseline in the Japanese UPDRS Part IV
Time frame: Baseline (Week 0) and Weeks 1-52
Summary of the Modified Hoehn & Yahr Criteria Stages
Time frame: Screening-Week 52
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale
Time frame: Weeks 1-52
Percentage of Participants Who Remained in the Study on the Indicated Days
Time frame: Days 0-364
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52
Time frame: Baseline (Screening) and Weeks 16 and 52
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
Time frame: Baseline (Screening) and Weeks 16 and 52
Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52
Time frame: Baseline (Screening) and Weeks 16 and 52
Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52
Time frame: Baseline (Screening) and Weeks 16 and 52
Change From Baseline in Prolactin at Weeks 16 and 52
Time frame: Baseline (Screening) and Weeks 16 and 52
Change From Baseline in Hematocrit at Weeks 16 and 52
Time frame: Baseline (Screening) and Weeks 16 and 52
Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52
Time frame: Baseline (Screening) and Weeks 16 and 52
Change From Baseline in Red Blood Cell Count at Weeks 16 and 52
Time frame: Baseline (Screening) and Weeks 16 and 52
Urinalysis Data
Time frame: Screening, Week 16, and Week 52
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52
Time frame: Baseline (Screening) and Weeks 16 and 52
Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52
Time frame: Baseline (Screening) and Weeks 16 and 52
Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52
Time frame: Baseline (Screening) and Weeks 16 and 52

Results and safety

Results posted to the registry on 23 Dec 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ropinirole PR/XR	62	42

Primary outcome: Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites

Time frame: Weeks 5-16. Geometric mean (95% Confidence Interval). Unit: picograms/milliliter (pg/mL)

Measure	Ropinirole PR/XR n = 10
SKF101468 (ropinirole), Cmax, fed	1563.784 (1252.648 to 1952.202)
SKF101468 (ropinirole), Cmax, fasted	1542.182 (1177.843 to 2019.221)
SKF101468 (ropinirole), Cmin, fed	728.404 (565.589 to 938.087)
SKF101468 (ropinirole), Cmin, fasted	725.103 (546.750 to 961.636)
SKF104557 (metabolite), Cmax, fed	1159.120 (1034.646 to 1298.569)
SKF104557 (metabolite), Cmax, fasted	1250.554 (1077.255 to 1451.731)
SKF104557 (metabolite), Cmin, fed	798.871 (693.490 to 920.266)
SKF104557 (metabolite), Cmin, fasted	786.097 (672.811 to 918.458)

Population analysed: Pharmacokinetic (PK) Population: participants who underwent blood sampling for PK research, excluding those who did not fulfill inclusion criteria and those who were considered to affect the evaluation of the PK research due to drug incompliance or other protocol violation.

Primary outcome: Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites

Time frame: Weeks 5-16. Geometric mean (95% Confidence Interval). Unit: hours*pg/mL

Measure	Ropinirole PR/XR n = 10
SKF101468 (ropinirole), fed	27206.103 (21908.900 to 33784.080)
SKF101468 (ropinirole), fasted	27191.804 (20738.729 to 35652.821)
SKF104557 (metabolite), fed	23090.150 (20629.318 to 25844.530)
SKF104557 (metabolite), fasted	24478.797 (21280.201 to 28158.169)
SKF89124 (metabolite), fed	1044.877 (882.879 to 1236.601)
SKF89124 (metabolite), fasted	1092.635 (888.375 to 1343.860)

Population analysed: PK Population

Primary outcome: Food Effects on Tmax of SKF101468 (Ropinirole) and Its Metabolites

Time frame: Weeks 5-16. Median (90% Confidence Interval). Unit: hours

Measure	Ropinirole PR/XR n = 10
SKF101468 (ropinirole)	2.000 (-0.100 to 5.000)
SKF104557 (metabolite)	3.983 (2.000 to 6.000)
SKF89124 (metabolite)	1.000 (-0.100 to 5.000)

Population analysed: PK Population

Primary outcome: Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites

Time frame: Weeks 1-16. Mean (Standard Deviation). Unit: pg/mL

Measure	Ropinirole PR/XR n = 61
SKF101468 (ropinirole), 2 mg, n=61	1804.87 (1757.062)
SKF101468 (ropinirole), 4 mg, n=58	3529.59 (1746.855)
SKF101468 (ropinirole), 6 mg, n=1	3820.20 (0.000)
SKF101468 (ropinirole), 8 mg, n=61	7598.90 (5512.105)
SKF101468 (ropinirole), 10 mg, n=17	9772.23 (3237.589)
SKF101468 (ropinirole), 12 mg, n=12	11971.49 (7211.987)
SKF101468 (ropinirole), 14 mg, n=9	12575.41 (5586.121)
SKF101468 (ropinirole), 16 mg, n=12	15467.01 (8292.375)

Population analysed: PK Population. Blood sampling was performed in all participants in the Fixed titration phase and Maintenance dose phase to measure trough concentration. The maintenance dose differs for individual participants.

28 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ropinirole PR/XR (Treatment Phase)	5 of 62 (8.1%)	51 of 62 (82.3%)	Not reported
Ropinirole PR/XR (Taper Phase)	1 of 62 (1.6%)	0 of 62 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ropinirole prolonged release/extended release(PR/XR) in people with Parkinson Disease, run by GlaxoSmithKline at 12 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites (time frame: Weeks 5-16). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00434304.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.