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Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients

Primary Purpose

Idiopathic Parkinson's Disease

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Rotigotine

Placebo Patch

L-dopa

About this trial

This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring Rotigotine, Neupro phase 3, Advanced-stage, Idiopathic Parkinson's Disease

Eligibility Criteria

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

Inclusion Criteria:

An Independent Ethics Committee (IEC)-approved written informed consent is signed and dated by the subject or by the legal representative
Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication application according to the judgment of the investigator
Subject has Idiopathic Parkinson's Disease of more than 3 years' duration, defined by the cardinal sign, Bradykinesia, plus the presence of at least 1 of the following: resting tremor, rigidity, or impairment of postural reflexes, and without any other known or suspected cause of Parkinsonism
The investigator must observe the subject in both the 'on' and 'off' state and determine that the subject is Hoehn & Yahr stage 2 through 4 in both the 'on' and 'off' state
Subject is male or female and aged ≥30 years at Screening (Visit 1)
Subject has a Mini Mental State Examination (MMSE) score of ≥25 at Screening (Visit 1)
Subject must be on a stable dose of L-dopa (either short-acting or sustained release [in combination with Benserazide or Carbidopa]) of at least 200 mg/day, administered in at least 2 intakes, for at least 28 days prior to Baseline (Visit 2)
Subject is not adequately controlled on a L-dopa dose (in combination with Benserazide or Carbidopa) which was judged by the treating physician to be optimal
Subject must be willing and able to accurately complete a subject diary on designated days (with assistance from caregivers, if required), recording periods when they are 'on without troublesome Dyskinesia', 'on with troublesome Dyskinesia', 'off', and sleeping
As part of the Screening (pretreatment) assessments, the subject must complete a diary over a period of 6 days, with 4 of the 6 diaries being 'valid' as determined by the investigator (see Section 9.1.1)
It must be clear to the investigator that the subject is able to differentiate between the 'on' and 'off' state and the 'valid' diaries confirm that the subject has an average of ≥2.5 h/day spent in the 'off' state
If the subject is receiving an Anticholinergic agent (eg, Benztropine, Trihexyphenidyl, Parsitan, Procyclidine, Biperiden), a monoamine oxidase (MAO)-B inhibitor (eg, Selegiline), and/or an N-methyl-d-aspartate (NMDA) antagonist (eg, Amantadine), he/she must have been on a stable dose for at least 28 days prior to Baseline (Visit 2) and be maintained on that dose for the duration of the study
Subject must be on a stable dose of all anti-Parkinsonian medications for at least 20 days prior to completing the 6 Baseline diaries

Exclusion Criteria:

Subject has previously participated in this study or subject has previously received the study medication under investigation in this study
Subject is participating in another study of an investigational drug or has done so within 28 days prior to the Baseline Visit (Visit 2)
Subject has a history of significant skin hypersensitivity to adhesive or other transdermal preparations, or recent unresolved contact dermatitis
Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1)
Subject has atypical Parkinson's syndrome(s) due to drugs (eg, Metoclopramide, Flunarizine), Metabolic Neurogenetic Disorders (eg, Wilson's Disease), Encephalitis, Cerebrovascular Disease, or Degenerative Disease (eg, Progressive Supranuclear Palsy)
Subject has a history of Pallidotomy, Thalamotomy, deep brain stimulation, or fetal tissue transplant
Subject has dementia, active psychosis or hallucinations, or severe depression
Subject is receiving therapy with a Dopamine agonist either concurrently or has done so within 28 days prior to the Baseline Visit (Visit 2)
Subject is receiving therapy with 1 of the following drugs either concurrently or within 28 days prior to Baseline (Visit 2): Alpha-methyl dopa, Metoclopramide, Reserpine, Neuroleptics (except specific atypical neuroleptics: Olanzapine, Ziprasidone, Aripiprazole, Clozapine, quetiapine), MAO-A inhibitors, Methylphenidate, or Amphetamine
Subject is currently receiving central nervous system (CNS) active therapy (eg, sedatives, hypnotics, antidepressants, anxiolytics), unless the dose has been stable for at least 28 days prior to Baseline (Visit 2) and is likely to remain stable for the duration of the study
Subject has a current diagnosis of Epilepsy, has a history of seizures as an adult, has a history of stroke, or has had a transient ischemic attack within 1 year prior to Screening (Visit 1)
Subject has clinically relevant hepatic dysfunction (as defined as a total bilirubin >2.0 mg/dL, or Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) >2 times the upper limit of the reference range)
Subject has clinically relevant renal dysfunction (serum creatinine >2.0 mg/dL [>178 μmol/L])
Subject has clinically relevant cardiac dysfunction (any cardiac disorder which in the opinion of the investigator would put the subject at risk of clinically relevant arrhythmia) and/or myocardial infarction within the last 12 months
Subject has a QT interval corrected for heart rate according to Bazett's formula (QTcB) of ≥500 ms at Screening (Visit 1)
Subject has a history of only symptomatic (not asymptomatic) orthostatic hypotension, with a decrease of systolic blood pressure (SBP) from supine to standing position of ≥2 0 mmHg or of ≥10 mmHg in DBP after 1 or 3 minutes within 28 days prior to Baseline (Visit 2), or SBP <105 mmHg at study entry 17. Subject has evidence of an impulse control disorder (ICD) at Screening (Visit 1)
Subject has a history of known intolerance/hypersensitivity to the following Antiemetics: Domperidone, Trimethobenzamide, Ondansetron, Tropisetron, Granisetron, and Glycopyrrolate
Subject has a history of chronic alcohol or drug abuse within the last 5 years
Subject is pregnant or nursing, or is of childbearing potential but (i) not surgically sterile or (ii) not using adequate birth control methods (including at least a double barrier method) or (iii) not sexually abstinent or (iv) not at least 2 years post-menopausal
Subject has any other clinically relevant medical condition, psychiatric condition, or laboratory abnormality which would, in the judgment of the investigator, interfere with the subject's ability to participate in the study

Exclusion Criteria:

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rotigotine

Placebo

Arm Description

Rotigotine, daily doses, treatment group

Placebo, daily doses, placebo group

Outcomes

Primary Outcome Measures

Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period

A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. A negative mean indicates a reduction of the time off during the conduct of the study

Secondary Outcome Measures

Percentage of Responders From Baseline to the End of the Doubleblind Maintenance Period

A Responder is defined as a subject with an ≥ 30 % decrease in absolute time spent 'off'

Percent Change in Absolute Time Spent "Off" From Baseline to the End of Double-blind Maintenance Period

A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. Absolute time "off" is defined as the mean number of hours marked "off" during a 24-hour period from all valid daily diary cards.

Percent Change in Relative Time Spent "Off" From Baseline to the End of Double-blind Maintenance Period

A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. Relative time spent "off" will be calculated in two stages. Each valid daily diary will have an associated relative time "off" calculated as relative time "off" for day = 100*[total absolute time "off" for day/ absolute time awake for day]. Relative time spent "off" is then calculated by averaging the daily relative time "off" for the valid days of that visit.

Change in Absolute Time Spent "on" From Baseline to the End of Double-blind Maintenance Period

Change in Relative Time Spent "on" From Baseline to the End of Double-blind Maintenance Period

A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was "off" when taking his/her L-dopa, he/she recorded the exact time their status changed to "on". Relative time spent "on" will be calculated in two stages. Each valid daily diary will have an associated relative time "on" calculated as relative time "on" for day = 100*[total absolute time "on" for day/ absolute time awake for day]. Relative time spent "on" is then calculated by averaging the daily relative time "on" for the valid days of that visit.

Percent Change in Absolute Time Spent "on" From Baseline to the End of Double-blind Maintenance Period

Percent Change in Relative Time Spent "on" From Baseline to the End of Double-blind Maintenance Period

A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was "off" when taking his/her L-dopa, he/she recorded the exact time their status changed to "on". Note for percent change calculations: when relative time at Baseline was 0%, the relative Baseline value was assumed to be 0.1 for calculation purposes. Relative time spent "on" will be calculated in two stages. Each valid daily diary will have an associated relative time "on" calculated as relative time "on" for day = 100*[total absolute time "on" for day/ absolute time awake for day]. Relative time spent "on" is then calculated by averaging the daily relative time "on" for the valid days of that visit.

Change in the Number of "Off" Periods From Baseline to the End of Double-blind Maintenance Period

A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication.

Change in Status of the Subject (on) After Wake-up With Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period

Change in Status of the Subject (on) After Wake-up Without Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period

Change in Status of the Subject (Off) After Wake-up From Baseline to the End of Double-blind Maintenance Period

A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the "off" state is presented below.

Change in Unified Parkinson's Disease Rating Scale (UPDRS Part III Motor Examination) During "on" Periods From Baseline to the End of Double-blind Maintenance Period

The UPDRS Part III (motor subscale) assessment consists of 27 questions, measured on a 5-Point scale (0 to 4). The sum score is calculated as sum of these 27 individual questions. This score ranges from 0 to 108, higher scores denote greater disability. A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.

Full Information

NCT ID

NCT01646255

First Posted

July 18, 2012

Last Updated

March 8, 2018

Sponsor

UCB Pharma

Collaborators

UCB Trading (Shanghai) Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01646255

Brief Title

Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients

Official Title

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of The Efficacy And Safety of Rotigotine Transdermal Patch In Chinese Subjects With Advanced-stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled On Levodopa

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UCB Pharma

Collaborators

UCB Trading (Shanghai) Co. Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study was to demonstrate that Rotigotine transdermal patch is efficacious in Chinese subjects with advanced-stage Idiopathic Parkinson's Disease as an adjuvant therapy.

Detailed Description

The study included a maximum 4-week Screening Period, a maximum 7-week Titration Period for advanced-stage Parkinson's disease, 12-week Maintenance Period, a maximum 12-day De-escalation Period for advanced-stage Parkinson's Disease and 30-day Safety Follow-Up Period. The maximum study duration for an individual subject with advanced-stage Parkinson's disease was 27 weeks.

6. Conditions and Keywords

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

Idiopathic Parkinson's Disease

Keywords

Rotigotine, Neupro phase 3, Advanced-stage, Idiopathic Parkinson's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

346 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rotigotine

Arm Type

Experimental

Arm Description

Rotigotine, daily doses, treatment group

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo, daily doses, placebo group

Intervention Type

Drug

Intervention Name(s)

Rotigotine

Intervention Description

Transdermal Patch Content: 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2) For advanced-stage Parkinson's Disease, subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 4 mg/24 h to 16 mg/24 h) for a maximum 7-week Titration Period, then 12 week maintenance period

Intervention Type

Drug

Intervention Name(s)

Placebo Patch

Intervention Description

Transdermal Patch Size: 20 cm^2, 30 cm^2, 40 cm^2 Subjects randomized to placebo received matching placebo patches

Intervention Type

Drug

Intervention Name(s)

L-dopa

Other Intervention Name(s)

Levodopa

Intervention Description

Subject must be on a stable dose of L-dopa (either short-acting or sustained release [in combination with benserazide or carbidopa]) of at least 200 mg/day, administered in at least 2 intakes, for at least 28 days prior to Baseline.

Primary Outcome Measure Information:

Title

Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period

Description

A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. A negative mean indicates a reduction of the time off during the conduct of the study

Time Frame

From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Secondary Outcome Measure Information:

Title

Percentage of Responders From Baseline to the End of the Doubleblind Maintenance Period

Description

A Responder is defined as a subject with an ≥ 30 % decrease in absolute time spent 'off'

Time Frame

From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Title

Percent Change in Absolute Time Spent "Off" From Baseline to the End of Double-blind Maintenance Period

Description

Time Frame

From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Title

Percent Change in Relative Time Spent "Off" From Baseline to the End of Double-blind Maintenance Period

Description

Time Frame

From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Title

Change in Absolute Time Spent "on" From Baseline to the End of Double-blind Maintenance Period

Description

Time Frame

From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Title

Change in Relative Time Spent "on" From Baseline to the End of Double-blind Maintenance Period

Description

Time Frame

From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Title

Percent Change in Absolute Time Spent "on" From Baseline to the End of Double-blind Maintenance Period

Description

Time Frame

From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Title

Percent Change in Relative Time Spent "on" From Baseline to the End of Double-blind Maintenance Period

Description

A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was "off" when taking his/her L-dopa, he/she recorded the exact time their status changed to "on". Note for percent change calculations: when relative time at Baseline was 0%, the relative Baseline value was assumed to be 0.1 for calculation purposes. Relative time spent "on" will be calculated in two stages. Each valid daily diary will have an associated relative time "on" calculated as relative time "on" for day = 100*[total absolute time "on" for day/ absolute time awake for day]. Relative time spent "on" is then calculated by averaging the daily relative time "on" for the valid days of that visit.

Time Frame

From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Title

Change in the Number of "Off" Periods From Baseline to the End of Double-blind Maintenance Period

Description

A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication.

Time Frame

From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Title

Change in Status of the Subject (on) After Wake-up With Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period

Description

Time Frame

From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Title

Change in Status of the Subject (on) After Wake-up Without Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period

Description

Time Frame

From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Title

Change in Status of the Subject (Off) After Wake-up From Baseline to the End of Double-blind Maintenance Period

Description

Time Frame

From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Title

Change in Unified Parkinson's Disease Rating Scale (UPDRS Part III Motor Examination) During "on" Periods From Baseline to the End of Double-blind Maintenance Period

Description

Time Frame

From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Inclusion Criteria: An Independent Ethics Committee (IEC)-approved written informed consent is signed and dated by the subject or by the legal representative Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication application according to the judgment of the investigator Subject has Idiopathic Parkinson's Disease of more than 3 years' duration, defined by the cardinal sign, Bradykinesia, plus the presence of at least 1 of the following: resting tremor, rigidity, or impairment of postural reflexes, and without any other known or suspected cause of Parkinsonism The investigator must observe the subject in both the 'on' and 'off' state and determine that the subject is Hoehn & Yahr stage 2 through 4 in both the 'on' and 'off' state Subject is male or female and aged ≥30 years at Screening (Visit 1) Subject has a Mini Mental State Examination (MMSE) score of ≥25 at Screening (Visit 1) Subject must be on a stable dose of L-dopa (either short-acting or sustained release [in combination with Benserazide or Carbidopa]) of at least 200 mg/day, administered in at least 2 intakes, for at least 28 days prior to Baseline (Visit 2) Subject is not adequately controlled on a L-dopa dose (in combination with Benserazide or Carbidopa) which was judged by the treating physician to be optimal Subject must be willing and able to accurately complete a subject diary on designated days (with assistance from caregivers, if required), recording periods when they are 'on without troublesome Dyskinesia', 'on with troublesome Dyskinesia', 'off', and sleeping As part of the Screening (pretreatment) assessments, the subject must complete a diary over a period of 6 days, with 4 of the 6 diaries being 'valid' as determined by the investigator (see Section 9.1.1) It must be clear to the investigator that the subject is able to differentiate between the 'on' and 'off' state and the 'valid' diaries confirm that the subject has an average of ≥2.5 h/day spent in the 'off' state If the subject is receiving an Anticholinergic agent (eg, Benztropine, Trihexyphenidyl, Parsitan, Procyclidine, Biperiden), a monoamine oxidase (MAO)-B inhibitor (eg, Selegiline), and/or an N-methyl-d-aspartate (NMDA) antagonist (eg, Amantadine), he/she must have been on a stable dose for at least 28 days prior to Baseline (Visit 2) and be maintained on that dose for the duration of the study Subject must be on a stable dose of all anti-Parkinsonian medications for at least 20 days prior to completing the 6 Baseline diaries Exclusion Criteria: Subject has previously participated in this study or subject has previously received the study medication under investigation in this study Subject is participating in another study of an investigational drug or has done so within 28 days prior to the Baseline Visit (Visit 2) Subject has a history of significant skin hypersensitivity to adhesive or other transdermal preparations, or recent unresolved contact dermatitis Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1) Subject has atypical Parkinson's syndrome(s) due to drugs (eg, Metoclopramide, Flunarizine), Metabolic Neurogenetic Disorders (eg, Wilson's Disease), Encephalitis, Cerebrovascular Disease, or Degenerative Disease (eg, Progressive Supranuclear Palsy) Subject has a history of Pallidotomy, Thalamotomy, deep brain stimulation, or fetal tissue transplant Subject has dementia, active psychosis or hallucinations, or severe depression Subject is receiving therapy with a Dopamine agonist either concurrently or has done so within 28 days prior to the Baseline Visit (Visit 2) Subject is receiving therapy with 1 of the following drugs either concurrently or within 28 days prior to Baseline (Visit 2): Alpha-methyl dopa, Metoclopramide, Reserpine, Neuroleptics (except specific atypical neuroleptics: Olanzapine, Ziprasidone, Aripiprazole, Clozapine, quetiapine), MAO-A inhibitors, Methylphenidate, or Amphetamine Subject is currently receiving central nervous system (CNS) active therapy (eg, sedatives, hypnotics, antidepressants, anxiolytics), unless the dose has been stable for at least 28 days prior to Baseline (Visit 2) and is likely to remain stable for the duration of the study Subject has a current diagnosis of Epilepsy, has a history of seizures as an adult, has a history of stroke, or has had a transient ischemic attack within 1 year prior to Screening (Visit 1) Subject has clinically relevant hepatic dysfunction (as defined as a total bilirubin >2.0 mg/dL, or Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) >2 times the upper limit of the reference range) Subject has clinically relevant renal dysfunction (serum creatinine >2.0 mg/dL [>178 μmol/L]) Subject has clinically relevant cardiac dysfunction (any cardiac disorder which in the opinion of the investigator would put the subject at risk of clinically relevant arrhythmia) and/or myocardial infarction within the last 12 months Subject has a QT interval corrected for heart rate according to Bazett's formula (QTcB) of ≥500 ms at Screening (Visit 1) Subject has a history of only symptomatic (not asymptomatic) orthostatic hypotension, with a decrease of systolic blood pressure (SBP) from supine to standing position of ≥2 0 mmHg or of ≥10 mmHg in DBP after 1 or 3 minutes within 28 days prior to Baseline (Visit 2), or SBP <105 mmHg at study entry 17. Subject has evidence of an impulse control disorder (ICD) at Screening (Visit 1) Subject has a history of known intolerance/hypersensitivity to the following Antiemetics: Domperidone, Trimethobenzamide, Ondansetron, Tropisetron, Granisetron, and Glycopyrrolate Subject has a history of chronic alcohol or drug abuse within the last 5 years Subject is pregnant or nursing, or is of childbearing potential but (i) not surgically sterile or (ii) not using adequate birth control methods (including at least a double barrier method) or (iii) not sexually abstinent or (iv) not at least 2 years post-menopausal Subject has any other clinically relevant medical condition, psychiatric condition, or laboratory abnormality which would, in the judgment of the investigator, interfere with the subject's ability to participate in the study Exclusion Criteria:

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

UCB Clinical Trial Call Center

Organizational Affiliation

1 877 822 9493

Official's Role

Study Director

Facility Information:

Facility Name

Sp1037 001

City

Beijing

Country

China

Facility Name

Sp1037 002

City

Beijing

Country

China

Facility Name

Sp1037 019

City

Beijing

Country

China

Facility Name

Sp1037 025

City

Beijing

Country

China

Facility Name

Sp1037 017

City

Changchun

Country

China

Facility Name

Sp1037 007

City

Chengdu

Country

China

Facility Name

Sp1037 027

City

Chengdu

Country

China

Facility Name

Sp1037 021

City

Fuzhou

Country

China

Facility Name

Sp1037 010

City

Guangzhou

Country

China

Facility Name

Sp1037 011

City

Guangzhou

Country

China

Facility Name

Sp1037 014

City

Guangzhou

Country

China

Facility Name

Sp1037 015

City

Guangzhou

Country

China

Facility Name

Sp1037 005

City

Hangzhou

Country

China

Facility Name

Sp1037 013

City

Hangzhou

Country

China

Facility Name

Sp1037 018

City

Hangzhou

Country

China

Facility Name

Sp1037 023

City

Jinan

Country

China

Facility Name

Sp1037 003

City

Shanghai

Country

China

Facility Name

Sp1037 004

City

Shanghai

Country

China

Facility Name

Sp1037 009

City

Shanghai

Country

China

Facility Name

Sp1037 008

City

Suzhou

Country

China

Facility Name

Sp1037 016

City

Tianjin

Country

China

Facility Name

Sp1037 006

City

Wuhan

Country

China

Facility Name

Sp1037 022

City

Wuhan

Country

China

Facility Name

Sp1037 024

City

Wuhan

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

28827011

Citation

Zhang ZX, Liu CF, Tao EX, Shao M, Liu YM, Wang J, Asgharnejad M, Xue HB, Surmann E, Bauer L. Rotigotine transdermal patch in Chinese patients with advanced Parkinson's disease: A randomized, double-blind, placebo-controlled pivotal study. Parkinsonism Relat Disord. 2017 Nov;44:6-12. doi: 10.1016/j.parkreldis.2017.08.015. Epub 2017 Aug 10.

Results Reference

result

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Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients

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Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients

Idiopathic Parkinson's Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

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