A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Of The Efficacy And Safety Of The Rotigotine Transdermal Patch In Chinese Subjects With Early-stage Idiopathic Parkinson's Disease
Rotigotine Versus Placebo As Double Blind Study To Evaluate The Efficacy In Early Stage Idiopathic Parkinson's Disease Patients
Sponsors
Source
UCB Pharma
Oversight Info
Has Dmc
No
Brief Summary
The primary objective is to demonstrate that the Rotigotine transdermal patch is efficacious
in Chinese subjects with early-stage idiopathic Parkinson's disease.
Detailed Description
The study includes a maximum 4-week Screening Period, a maximum 4-week Titration Period for
early-stage Parkinson's disease 24-week Maintenance Period, a maximum 6-day De-escalation
Period and 30-day Safety Follow-Up Period. The maximum study durations for an individual
subject with early-stage Parkinson's disease will be 36 weeks.
Overall Status
Completed
Start Date
2012-07-01
Completion Date
2014-05-01
Primary Completion Date
2014-05-01
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
Change in the Sum of the Score From the Activities of Daily Living (ADL) Scale and Motor Examination in the Unified Parkinson's Disease Rating Scale (UPDRS) (Parts II+III, a UPDRS Subtotal) From Baseline to the End of Double-blind Maintenance Period |
From Baseline (Week 0) to end of Maintenance Period (up to Week 24) |
Secondary Outcome
Measure |
Time Frame |
Response to Therapy, Defined as ≥20 % Decrease in the Sum of Scores From Activities of Daily Living (ADL) & Motor Examination in Unified Parkinson's Disease Rating Scale (UPDRS Parts II+III, a UPDRS Subtotal) From Baseline to End of Maintenance Period |
From Baseline (Week 0) to end of Maintenance Period (up to Week 24) |
Change in Unified Parkinson's Disease Rating Scale [UPDRS Part II (ADL)] From Baseline to the End of the Double-blind Maintenance Period |
From Baseline (Week 0) to end of Maintenance Period (up to Week 24) |
Change in Unified Parkinson's Disease Rating Scale [UPDRS Part III (Motor Examination)] From Baseline to the End of the Double-blind Maintenance Period |
From Baseline (Week 0) to end of Maintenance Period (up to Week 24) |
Enrollment
249
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
Transdermal Patch
Content:
2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)
For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period
Arm Group Label
Rotigotine
Intervention Type
Drug
Intervention Name
Description
Transdermal Patch
Size:
10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2
Subjects randomized to placebo will receive matching placebo patches
Arm Group Label
Placebo
Eligibility
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, visit schedule or study medication intake according to the judgment of the
investigator
- Subject has Idiopathic Parkinson's Disease of ≤5 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
- Subject is Hoehn & Yahr stage ≤3
- Subject is male or female aged ≥30 years at Screening (Visit 1)
- Subject has a Mini Mental State Examination (MMSE) score of ≥25
- Subject has a Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III)
of ≥10 at Baseline (Visit 2)
- If the subject is receiving an Anticholinergic agent (eg, Benztropine,
Trihexyphenidyl, Parsitan, Procyclidine, Biperiden), a monoamine oxidase (MAO)-B
inhibitor (eg, Selegiline), 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
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 L dopa/carbidopa and/or L-dopa/benserazide within 28
days of Baseline (Visit 2) or has received L-dopa/carbidopa and/or L-dopa/benserazide
for more than 6 months since diagnosis
- 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 (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)
greater than 2 times the upper limit of the reference range)
- Subject has clinically relevant renal dysfunction (serum creatinine >2.0 mg/dL [>178
umol/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
≥20 mmHg or of ≥10 mmHg in diastolic blood pressure (DBP) after 1 or 3 minutes within
28 days prior to the Baseline Visit (Visit 2), or SBP less than 105 mmHg at study
entry
- 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
Gender
All
Minimum Age
30 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
UCB Clinical Trial Call Center |
Study Director |
1 877 822 9493 |
Location
Facility |
001 Beijing China |
002 Beijing China |
019 Beijing China |
025 Beijing China |
017 Changchun China |
007 Chengdu China |
027 Chengdu China |
021 Fuzhou China |
010 Guangzhou China |
011 Guangzhou China |
014 Guangzhou China |
015 Guangzhou China |
005 Hangzhou China |
013 Hangzhou China |
018 Hangzhou China |
023 Jinan China |
003 Shanghai China |
004 Shanghai China |
009 Shanghai China |
008 Suzhou China |
016 Tianjin China |
006 Wuhan China |
022 Wuhan China |
024 Wuhan China |
Location Countries
Country
China
Verification Date
2015-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Rotigotine
Arm Group
Arm Group Label
Rotigotine
Arm Group Type
Experimental
Description
Rotigotine, daily doses, treatment group
Arm Group Label
Placebo
Arm Group Type
Placebo Comparator
Description
Placebo, daily doses, placebo group
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Study First Submitted
July 18, 2012
Study First Submitted Qc
July 18, 2012
Study First Posted
July 20, 2012
Last Update Submitted
July 14, 2015
Last Update Submitted Qc
July 14, 2015
Last Update Posted
August 11, 2015
Results First Submitted
May 20, 2015
Results First Submitted Qc
July 14, 2015
Results First Posted
August 11, 2015
ClinicalTrials.gov processed this data on December 10, 2019
Conditions
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conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.