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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01646268
First received: July 18, 2012
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

The primary objective is to demonstrate that the Rotigotine transdermal patch is efficacious in Chinese subjects with early-stage idiopathic Parkinson's disease.


Condition Intervention Phase
IDIOPATHIC PARKINSON'S DISEASE
Drug: Rotigotine
Drug: Placebo Patch
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 249
Study Start Date: July 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rotigotine
Rotigotine, daily doses, treatment group
Drug: Rotigotine

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

Placebo Comparator: Placebo
Placebo, daily doses, placebo group
Drug: Placebo Patch

Transdermal Patch

Size:

10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2

Subjects randomized to placebo will receive matching placebo patches


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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646268

Locations
China
001
Beijing, China
002
Beijing, China
019
Beijing, China
025
Beijing, China
017
Changchun, China
007
Chengdu, China
027
Chengdu, China
021
Fuzhou, China
011
Guangzhou, China
010
Guangzhou, China
014
Guangzhou, China
015
Guangzhou, China
013
Hangzhou, China
005
Hangzhou, China
018
Hangzhou, China
023
Jinan, China
004
Shanghai, China
009
Shanghai, China
003
Shanghai, China
008
Suzhou, China
016
Tianjin, China
006
Wuhan, China
022
Wuhan, China
024
Wuhan, China
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center 1 877 822 9493
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01646268     History of Changes
Other Study ID Numbers: SP0914
Study First Received: July 18, 2012
Last Updated: June 10, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by UCB, Inc.:
Rotigotine
Neupro phase 3
Early phase
Idiopathic Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014