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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01646255
• Date of registration: 18/07/2012
• Prospective Registration: No
• Primary sponsor: UCB Pharma
• Public title: Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients
• Scientific 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
• Date of first enrolment: July 2012
• Target sample size: 346
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01646255
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• 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:

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) n


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: L-dopa

Drug: Rotigotine

Primary Outcome(s)

Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)]

Secondary Outcome(s)

Change in Relative Time Spent "on" From Baseline to the End of Double-blind Maintenance Period [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)]

Percent Change in Absolute Time Spent "on" From Baseline to the End of Double-blind Maintenance Period [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)]

Percentage of Responders From Baseline to the End of the Doubleblind Maintenance Period [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)]

Change in Status of the Subject (Off) After Wake-up From Baseline to the End of Double-blind Maintenance Period [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)]

Change in Absolute Time Spent "on" From Baseline to the End of Double-blind Maintenance Period [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)]

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 [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)]

Change in Status of the Subject (on) After Wake-up With Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)]

Percent Change in Relative Time Spent "Off" From Baseline to the End of Double-blind Maintenance Period [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)]

Change in Status of the Subject (on) After Wake-up Without Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)]

Change in the Number of "Off" Periods From Baseline to the End of Double-blind Maintenance Period [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)]

Percent Change in Absolute Time Spent "Off" From Baseline to the End of Double-blind Maintenance Period [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)]

Percent Change in Relative Time Spent "on" From Baseline to the End of Double-blind Maintenance Period [Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)]

Secondary ID(s)

SP1037

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

UCB Trading (Shanghai) Co. Ltd.

Results

• Results available: Yes
• Date Posted: 22/01/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01646255