Rotigotine Versus Placebo As Double Blind Study To Evaluate The Efficacy In Early Stage Idiopathic Parkinson's Disease Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01646268
• Date of registration: 18/07/2012
• Prospective Registration: No
• Primary sponsor: UCB Pharma
• Public title: Rotigotine Versus Placebo As Double Blind Study To Evaluate The Efficacy In Early Stage Idiopathic Parkinson's Disease Patients
• Scientific title: 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
• Date of first enrolment: July 2012
• Target sample size: 249
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01646268
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: 1 877 822 9493

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

IDIOPATHIC PARKINSON'S DISEASE

Intervention(s)

Drug: Placebo Patch

Drug: Rotigotine

Primary Outcome(s)

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 [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 24)]

Secondary Outcome(s)

Change in Unified Parkinson's Disease Rating Scale [UPDRS Part III (Motor Examination)] From Baseline to the End of the Double-blind Maintenance Period [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 24)]

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 [Time Frame: 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 [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 24)]

Secondary ID(s)

SP0914

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/08/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01646268