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A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's

Primary Purpose

Parkinson Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ropinirole prolonged release

ropinirole immediate release

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring safety, efficacy, L-dopa, ropinirole PR, Parkinson's disease, ropinirole IR, adjunctive therapy, superiority, REQUIP, health outcomes

Eligibility Criteria

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

Inclusion criteria: Patients with a diagnosis of advanced idiopathic Parkinson's disease (according to modified Hoehn & Yahr criteria Stages II-IV) whose symptoms are not adequately controlled with L-dopa. Exclusion criteria: Patients with late stage advanced Parkinson's disease with incapacitating dyskinesias on a stable dose of L-dopa. Current, or history of, (within the previous 3 months), significant and/or uncontrolled psychiatric, haematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or active malignancy. Recent history of severe dizziness or fainting on standing. Dementia, neurotic behaviour, crippling degenerative arthritis or limb amputations, or prior or current major psychosis. Recent history or current evidence of drug abuse or alcoholism. Use of a dopamine agonist within 4 weeks of starting the study. Personal or family history of an allergic reaction to ropinirole.

Outcomes

Primary Outcome Measures

Percentage of participants with at least a 20% maintained reduction in Baseline time spent "off" at Week 24 last observation carried forward (LOCF)

Diary cards completed by the participants was used to assess the duration of "off" and "on" periods. During the treatment period 2, 24 hour diary cards were completed by the participants (except for the Baseline period when four diary cards were completed). The participants completed diary cards on the same 2 days of each relevant week. Each 30 minute period was marked as either "off", "on" or asleep. Troublesome dyskinesias were involuntary twisting, turning movements which caused discomfort were also recorded. The general definition of "off" included a lack of mobility with or without additional features such as tremor or rigidity. The total number of hours spent both "off" and "on" or asleep were summed for the two (four for the Baseline Period) 24 hour diary cards and the amount of awake time spent "off" per 24 hour period was determined. Percentage of participants with at least a 20% maintained reduction in baseline time spent "off" at Week 24 were presented.

Secondary Outcome Measures

Mean change from Baseline in percentage awake time spent "off" at Week 24 LOCF

Diary cards completed by the Participants was used to assess the duration of "off" and "on" periods. During the Treatment Period 2 24 hour diary cards were completed by the Participants (except for the Baseline Period when four diary cards were completed). The Participants completed diary cards on the same 2 days of each relevant week. Each 30 minute period was marked as either "off", "on" or asleep. Troublesome dyskinesias were involuntary twisting, turning movements which caused discomfort were also recorded. The general definition of "off" included a lack of mobility with or without additional features such as tremor or rigidity. The total number of hours spent both "off" and "on" or asleep were summed for the two (four for the Baseline Period) 24 hour diary cards and the amount of awake time spent "off" per 24 hour period was determined. Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values from the on-treatment values.

Number of participants with a score of 'much improved' or 'very much improved' on the clinical global impression-global improvement (CGI-I) scale at Week 24 LOCF

The CGI-I global improvement scale allows the investigator to rate the participant's total improvement from beginning the treatment (baseline). The scale was rated as 1-7, from 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse and 7: very much worse. CGI global improvement scale was assessed at Week 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 (and at early withdrawal, if applicable. Higher score indicates worsening and lower score indicates very much improvement. A participant was considered as a CGI-I responder when he/she had a score of (1) Very Much Improved or (2) Much Improved.

Mean change from baseline in the total motor score (part III) of the Unified Parkinson's Disease Rating Scale (UPDRS), with participants in an "on" state at Week 24 LOCF

The UPDRS Part III assessed motor examination on 18-31 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms and lower score indicates less severe PD symptoms. "On" state was where PD symptoms were well controlled by the drug. Week 0 was the Baseline and change from Baseline for an individual participant was calculated by subtracting the Baseline values from the on-treatment values. Mean change from Baseline in the total motor score with participants in an "on" state was reported.

Mean change from baseline in the total motor score (part III) of the UPDRS, with participants in an "off" state at Week 24 LOCF

The UPDRS Part III assessed motor examination on 18-31 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms and lower score indicates less severe PD symptoms. Week 0 was the baseline and change from Baseline for an individual participant was calculated by subtracting the baseline values from the on-treatment values. Mean change from baseline in the total motor score with participants in an "off" state was reported.

Mean change from baseline in the total Activities of daily living (ADL) score (part II) of the UPDRS, with participants in an "on" state at Week 24 LOCF

This component included items 5-17 of the UPDRS was evaluated by calculating the total score for the 13 items. Participants receive a score of 0-4 points per item and had a value ranging from 0 to 52. The maximum total score was 52. The total ADL Score of the UPDRS ranged from 0 to 52, where 0=normal/no symptoms and 52=worst possible case. Participants recorded responses in both "on" and "off" states at each visit due to the nature of questionnaire which generated ADL score at each visit. A higher score indicates more severe PD symptoms. "On" state was where PD symptoms were well controlled by the drug. Week 0 was the Baseline and change from Baseline for an individual participant was calculated by subtracting the baseline values from the on-treatment values for each state separately.

Mean change from baseline in the total ADL score (part II) of the UPDRS, with participants in an "off" state at Week 24 LOCF

This component included items 5-17 of the UPDRS was evaluated by calculating the total score for the 13 items. Participants receive a score of 0-4 points per item and had a value ranging from 0 to 52. The maximum total score was 52. The total ADL Score of the UPDRS ranged from 0 to 52, where 0=normal/no symptoms and 52=worst possible case. Participants recorded responses in both "on" and "off" states at each visit due to the nature of questionnaire which generated ADL score at each visit. A higher score indicates more severe PD symptoms. "Off" state was where PD symptoms were not adequately controlled by the drug. Week 0 was the baseline and change from Baseline for an individual participant was calculated by subtracting the baseline values from the on-treatment values for each state separately.

Mean change from baseline in the total score (parts I-III) of the UPDRS, with participants in an "on" state at Week 24 LOCF

The total UPDRS score was calculated by the sum of the values for each component (Part I + Part II + Part III) as determined by the physician. The UPDRS Part I scored mentation, behavior and mood and scores ranged from 0-16. The UPDRS Part II was the ADL and score ranged from 0-52. The UPDRS Part III was the Motor Examination (Total Motor Score )and scores ranged from 0-108. The total UPDRS (Part I + II + III) score ranged from 0-176 with the higher score indicating the worse condition. Tests were performed when the participant was in the "on" state of Parkinson's. Baseline was defined as Week 0 assesment. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.

Mean change from baseline in the total score (parts I-III) of the UPDRS, with participants in an "off" state at Week 24 LOCF

The total UPDRS score was calculated by the sum of the values for each component (Part I + Part II + Part III) as determined by the physician. The UPDRS Part I scored mentation, behavior and mood and scores ranged from 0-16. The UPDRS Part II was the ADL and score ranged from 0-52. The UPDRS Part III was the Motor Examination (Total Motor Score)and scores ranged from 0-108. The total UPDRS (Part I + II + III) score ranged from 0-176 with the higher score indicating the worse condition. Tests were performed when the participant was in the "off" state of Parkinson's. Baseline was defined as Week 0 assessment. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.

Mean change from baseline to Week 24 LOCF in the thermometer score of the Euro-Qol 5D (EQ-5D)

The EQ-5D was a standardized, participant-administered instrument which produced a simple descriptive profile (thermometer) and a single index value (utility) of a participant's current health status. Thermometer was a 20-cm Visual Analogue Scale (VAS) anchored at 0: worse imaginable health state and 100: best imaginable health state. Participants were required to indicate how good or bad was their health by marking a line on the scale. The point at which the line crossed the thermometer was taken as the score. Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values from the on-treatment values.

Mean change from baseline to Week 24 LOCF in the utility score of the EQ-5D

The EQ-5D was a standardized, participant-administered instrument which produced a simple descriptive profile (thermometer) and a single index value (utility) of a participant's current health status. Utility score was computed from 5 dimensions of health: (mobility, self-care, usual activities, pain/discomfort, anxiety /depression). Each dimension comprised 3 levels (some, moderate, extreme problems), and generated a total of 243 theoretically possible health states. The Utility score was combined scores from 5 dimensions, which valued between -0.594 (representing the worse possible health) and 1 (representing the perfect health). Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values from the on-treatment values.

Mean change from Baseline in the total score of the Parkinson's Disease Sleep Scale (PDSS) at Week 24 LOCF

The PDSS comprised of a series of 15 VAS addressing commonly reported symptoms associated with sleep disturbance in PD. The participant or caregiver completed the scale based on their experiences in the past week. Scores for each item ranged from 0 (representing the most severe) to 10 (the least severe). The maximum score for the PDSS was 150 (participant was free of all symptoms). Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values from the on-treatment values.

Mean change from Baseline in the total movement severity score of the abnormal involuntary movement scale (AIMS), with participants in an "on" state at Week 24 LOCF

The AIMS was a 12 item, investigator performed assessment of facial and oral movements, extremity movements, trunk movements, global judgments and dental status according to predefined criteria. Items 1-10 were rated on a 5 point severity scale with 0: none to 4: severe. Items 11 and 12 were yes or no items. The AIMS total movement severity score was obtained by summing together the responses to the first seven items and ranged from 0 to 28, with higher scores representing more severe involuntary movement. The AIMS was assessed at Week 0, 12, 24. Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values from the on-treatment values.

Percentage of participants requiring re-instatement of L-dopa

Participants were defined as having a re-instatement of L-dopa, if at any point during the on-treatment phase (excluding down-titration), their dose of L-dopa was increased, up to, or above their baseline level. Percentage of participants requiring reinstatement of L-dopa was reported at Week 24.

Mean change from baseline in the dose of L-dopa at Week 24 LOCF

The start and stop dates of L-Dopa medication were used to determine the dose being taken on a specific date or at an assessment. The dose recorded on the actual date of assessment was used when reporting the corresponding dose. The total daily dose of L-dopa (mg) was calculated as Unit dose per tablet (mg) * Daily Frequency * No of Tablets per administration. Mean change from baseline in the dose of L-dopa at Week 24 was reported. Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values from the on-treatment values.

Incidence of all adverse events (AE) and serious adverse events (SAE)

Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.

Number of participants who were unable to titrate weekly during the 4 week forced up titration due to poor tolerability

There was no specific question in the CRF to capture the reason why participants were unable to titrate weekly during this period, the data on the reason for withdrawal in the CRF was thus evaluated in those participants who withdrew during the forced titration period. Data for the number of participants withdrawn (Yes/No) is presented.

Full Information

NCT ID

NCT00331149

First Posted

May 26, 2006

Last Updated

August 21, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00331149

Brief Title

A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's

Official Title

A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment With Ropinirole Immediate Release Tablets (REQUIP IR) or Ropinirole Prolonged Release Tablets (SK&F-101468) in Advanced Stage Parkinson's Disease Subjects Who Are Not Adequately Controlled on L-dopa.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

June 20, 2006 (Actual)

Primary Completion Date

August 29, 2007 (Actual)

Study Completion Date

August 29, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study was designed to compare the effectiveness and tolerability of a new prolonged release formulation of ropinirole with the currently marketed immediate release formulation which is prescribed in many countries. The new prolonged release formulation allows the drug to be taken once a day rather than three times a day. This study will also evaluate the side effects of the new prolonged release formulation of ropinirole

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

safety, efficacy, L-dopa, ropinirole PR, Parkinson's disease, ropinirole IR, adjunctive therapy, superiority, REQUIP, health outcomes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Allocation

Randomized

Enrollment

343 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Ropinirole prolonged release

Intervention Type

Drug

Intervention Name(s)

ropinirole immediate release

Other Intervention Name(s)

Ropinirole prolonged release

Primary Outcome Measure Information:

Title

Percentage of participants with at least a 20% maintained reduction in Baseline time spent "off" at Week 24 last observation carried forward (LOCF)

Description

Time Frame

Baseline (Week 0) and Week 24

Secondary Outcome Measure Information:

Title

Mean change from Baseline in percentage awake time spent "off" at Week 24 LOCF

Description

Time Frame

Baseline (Week 0) and Week 24

Title

Number of participants with a score of 'much improved' or 'very much improved' on the clinical global impression-global improvement (CGI-I) scale at Week 24 LOCF

Description

Time Frame

Week 24

Title

Mean change from baseline in the total motor score (part III) of the Unified Parkinson's Disease Rating Scale (UPDRS), with participants in an "on" state at Week 24 LOCF

Description

Time Frame

Baseline (Week 0) and Week 24

Title

Mean change from baseline in the total motor score (part III) of the UPDRS, with participants in an "off" state at Week 24 LOCF

Description

The UPDRS Part III assessed motor examination on 18-31 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms and lower score indicates less severe PD symptoms. Week 0 was the baseline and change from Baseline for an individual participant was calculated by subtracting the baseline values from the on-treatment values. Mean change from baseline in the total motor score with participants in an "off" state was reported.

Time Frame

Baseline (Week 0) and Week 24

Title

Mean change from baseline in the total Activities of daily living (ADL) score (part II) of the UPDRS, with participants in an "on" state at Week 24 LOCF

Description

Time Frame

Baseline (Week 0) and Week 24

Title

Mean change from baseline in the total ADL score (part II) of the UPDRS, with participants in an "off" state at Week 24 LOCF

Description

This component included items 5-17 of the UPDRS was evaluated by calculating the total score for the 13 items. Participants receive a score of 0-4 points per item and had a value ranging from 0 to 52. The maximum total score was 52. The total ADL Score of the UPDRS ranged from 0 to 52, where 0=normal/no symptoms and 52=worst possible case. Participants recorded responses in both "on" and "off" states at each visit due to the nature of questionnaire which generated ADL score at each visit. A higher score indicates more severe PD symptoms. "Off" state was where PD symptoms were not adequately controlled by the drug. Week 0 was the baseline and change from Baseline for an individual participant was calculated by subtracting the baseline values from the on-treatment values for each state separately.

Time Frame

Baseline (Week 0) and Week 24

Title

Mean change from baseline in the total score (parts I-III) of the UPDRS, with participants in an "on" state at Week 24 LOCF

Description

Time Frame

Baseline (Week 0) and Week 24

Title

Mean change from baseline in the total score (parts I-III) of the UPDRS, with participants in an "off" state at Week 24 LOCF

Description

The total UPDRS score was calculated by the sum of the values for each component (Part I + Part II + Part III) as determined by the physician. The UPDRS Part I scored mentation, behavior and mood and scores ranged from 0-16. The UPDRS Part II was the ADL and score ranged from 0-52. The UPDRS Part III was the Motor Examination (Total Motor Score)and scores ranged from 0-108. The total UPDRS (Part I + II + III) score ranged from 0-176 with the higher score indicating the worse condition. Tests were performed when the participant was in the "off" state of Parkinson's. Baseline was defined as Week 0 assessment. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.

Time Frame

Baseline (Week 0) and Week 24

Title

Mean change from baseline to Week 24 LOCF in the thermometer score of the Euro-Qol 5D (EQ-5D)

Description

Time Frame

Baseline (Week 0) and Week 24

Title

Mean change from baseline to Week 24 LOCF in the utility score of the EQ-5D

Description

The EQ-5D was a standardized, participant-administered instrument which produced a simple descriptive profile (thermometer) and a single index value (utility) of a participant's current health status. Utility score was computed from 5 dimensions of health: (mobility, self-care, usual activities, pain/discomfort, anxiety /depression). Each dimension comprised 3 levels (some, moderate, extreme problems), and generated a total of 243 theoretically possible health states. The Utility score was combined scores from 5 dimensions, which valued between -0.594 (representing the worse possible health) and 1 (representing the perfect health). Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values from the on-treatment values.

Time Frame

Baseline (Week 0) and Week 24

Title

Mean change from Baseline in the total score of the Parkinson's Disease Sleep Scale (PDSS) at Week 24 LOCF

Description

Time Frame

Baseline (Week 0) and Week 24

Title

Mean change from Baseline in the total movement severity score of the abnormal involuntary movement scale (AIMS), with participants in an "on" state at Week 24 LOCF

Description

Time Frame

Baseline (Week 0) and Week 24

Title

Percentage of participants requiring re-instatement of L-dopa

Description

Time Frame

Week 24

Title

Mean change from baseline in the dose of L-dopa at Week 24 LOCF

Description

Time Frame

Baseline (Week 0) and Week 24

Title

Incidence of all adverse events (AE) and serious adverse events (SAE)

Description

Time Frame

Up to Week 27

Title

Number of participants who were unable to titrate weekly during the 4 week forced up titration due to poor tolerability

Description

Time Frame

Up to Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Sofia

ZIP/Postal Code

1113

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1527

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3J 3T1

Country

Canada

Facility Name

GSK Investigational Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1G 4G3

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

GSK Investigational Site

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8X 5A6

Country

Canada

Facility Name

GSK Investigational Site

City

Québec

ZIP/Postal Code

G1R 3X5

Country

Canada

Facility Name

GSK Investigational Site

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

GSK Investigational Site

City

Ostrava - Poruba

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

GSK Investigational Site

City

Pardubice

ZIP/Postal Code

535 03

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 2

ZIP/Postal Code

120 00

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 5

ZIP/Postal Code

150 18

Country

Czechia

Facility Name

GSK Investigational Site

City

Aix en Provence

ZIP/Postal Code

13616

Country

France

Facility Name

GSK Investigational Site

City

Clermont Ferrand

ZIP/Postal Code

63003

Country

France

Facility Name

GSK Investigational Site

City

Dijon

ZIP/Postal Code

21000

Country

France

Facility Name

GSK Investigational Site

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

GSK Investigational Site

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

GSK Investigational Site

City

Paris Cedex 14

ZIP/Postal Code

75674

Country

France

Facility Name

GSK Investigational Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

80331

Country

Germany

Facility Name

GSK Investigational Site

City

Nuernberg

State/Province

Bayern

ZIP/Postal Code

90402

Country

Germany

Facility Name

GSK Investigational Site

City

Unterhaching

State/Province

Bayern

ZIP/Postal Code

82008

Country

Germany

Facility Name

GSK Investigational Site

City

Achim

State/Province

Niedersachsen

ZIP/Postal Code

28832

Country

Germany

Facility Name

GSK Investigational Site

City

Hildesheim

State/Province

Niedersachsen

ZIP/Postal Code

31134

Country

Germany

Facility Name

GSK Investigational Site

City

Westerstede

State/Province

Niedersachsen

ZIP/Postal Code

26655

Country

Germany

Facility Name

GSK Investigational Site

City

Bielefeld

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

33647

Country

Germany

Facility Name

GSK Investigational Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01097

Country

Germany

Facility Name

GSK Investigational Site

City

Gera

State/Province

Thueringen

ZIP/Postal Code

07551

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10178

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

12163

Country

Germany

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1021

Country

Hungary

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1135

Country

Hungary

Facility Name

GSK Investigational Site

City

Debrecen

ZIP/Postal Code

4012

Country

Hungary

Facility Name

GSK Investigational Site

City

Szeged

ZIP/Postal Code

6725

Country

Hungary

Facility Name

GSK Investigational Site

City

Chieti Scalo

State/Province

Abruzzo

ZIP/Postal Code

66013

Country

Italy

Facility Name

GSK Investigational Site

City

Napoli

State/Province

Campania

ZIP/Postal Code

80131

Country

Italy

Facility Name

GSK Investigational Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00148

Country

Italy

Facility Name

GSK Investigational Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00163

Country

Italy

Facility Name

GSK Investigational Site

City

Genova

State/Province

Liguria

ZIP/Postal Code

16132

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20126

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20133

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20142

Country

Italy

Facility Name

GSK Investigational Site

City

Grosseto

State/Province

Toscana

ZIP/Postal Code

58100

Country

Italy

Facility Name

GSK Investigational Site

City

Lido di Camaiore (Lucca)

State/Province

Toscana

ZIP/Postal Code

55043

Country

Italy

Facility Name

GSK Investigational Site

City

Arcugnano (VI)

State/Province

Veneto

ZIP/Postal Code

36057

Country

Italy

Facility Name

GSK Investigational Site

City

Gdansk

ZIP/Postal Code

80-299

Country

Poland

Facility Name

GSK Investigational Site

City

Katowice

ZIP/Postal Code

40-752

Country

Poland

Facility Name

GSK Investigational Site

City

Krakow

ZIP/Postal Code

31-530

Country

Poland

Facility Name

GSK Investigational Site

City

Lublin

ZIP/Postal Code

20-718

Country

Poland

Facility Name

GSK Investigational Site

City

Poznan

ZIP/Postal Code

61-298

Country

Poland

Facility Name

GSK Investigational Site

City

Warsaw

ZIP/Postal Code

02-097

Country

Poland

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

11241

Country

Romania

Facility Name

GSK Investigational Site

City

Cluj Napoca

ZIP/Postal Code

400012

Country

Romania

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

117049

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

117593

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

119881

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

125101

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

125367

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St-Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St.-Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0040

Country

South Africa

Facility Name

GSK Investigational Site

City

Bloemfontein

ZIP/Postal Code

9301

Country

South Africa

Facility Name

GSK Investigational Site

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

GSK Investigational Site

City

Sunninghill

ZIP/Postal Code

2157

Country

South Africa

Facility Name

GSK Investigational Site

City

Alcorcon (Madrid)

ZIP/Postal Code

28922

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

GSK Investigational Site

City

San Sebastian

ZIP/Postal Code

20011

Country

Spain

Facility Name

GSK Investigational Site

City

Sant Cugat del Valles (Barcelona)

ZIP/Postal Code

08190

Country

Spain

Facility Name

GSK Investigational Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

GSK Investigational Site

City

Sevilla

ZIP/Postal Code

41071

Country

Spain

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

01021

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

04114

Country

Ukraine

Facility Name

GSK Investigational Site

City

Poltava

ZIP/Postal Code

36024

Country

Ukraine

Facility Name

GSK Investigational Site

City

Vinnitsa

ZIP/Postal Code

21005

Country

Ukraine

Facility Name

GSK Investigational Site

City

Bristol

State/Province

Gloucestershire

ZIP/Postal Code

BS16 1LE

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Stoke-on-Trent

State/Province

Staffordshire

ZIP/Postal Code

ST4 7PA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Chertsey

ZIP/Postal Code

KT16 0QA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Leigh

ZIP/Postal Code

WN7 1HS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Oxford

ZIP/Postal Code

OX3 9DU

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's

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A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's

Parkinson Disease

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial