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

NCT01646268 | Completed Phase 3 Results

• 1 other identifier: SP0914
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 24

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.

Conditions

IDIOPATHIC PARKINSON'S DISEASE

Keywords

Rotigotine; Neupro phase 3; Early phase; Idiopathic Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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

  The UPDRS assessments (Parts II+III) will be performed at every visit. For the assessment of the subject's disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject's disease state in the "on" state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). For the assessment of the subject's motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the "on" state. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score is calculated as sum of these 27 individual scores. The sum score ranges from 0 to 160, higher scores denote greater disability.

  From Baseline (Week 0) to end of Maintenance Period (up to Week 24)

Secondary Outcomes (3)

• 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)

Study Arms (2)

Rotigotine

EXPERIMENTAL

Rotigotine, daily doses, treatment group

Drug: Rotigotine

Placebo

PLACEBO COMPARATOR

Placebo, daily doses, placebo group

Drug: Placebo Patch

Interventions

Rotigotine DRUG

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

Rotigotine

Placebo Patch DRUG

Transdermal Patch Size: 10 cm\^2, 20 cm\^2, 30 cm\^2, 40 cm\^2 Subjects randomized to placebo will receive matching placebo patches

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (24)

001

Beijing, China

Location

002

Beijing, China

Location

019

Beijing, China

Location

025

Beijing, China

Location

017

Changchun, China

Location

007

Chengdu, China

Location

027

Chengdu, China

Location

021

Fuzhou, China

Location

010

Guangzhou, China

Location

011

Guangzhou, China

Location

014

Guangzhou, China

Location

015

Guangzhou, China

Location

005

Hangzhou, China

Location

013

Hangzhou, China

Location

018

Hangzhou, China

Location

023

Jinan, China

Location

003

Shanghai, China

Location

004

Shanghai, China

Location

009

Shanghai, China

Location

008

Suzhou, China

Location

016

Tianjin, China

Location

006

Wuhan, China

Location

022

Wuhan, China

Location

024

Wuhan, China

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Study Director
• Organization: UCB Clinical Trial Call Center

+1 844-599-2279

Study Officials

• UCB Clinical Trial Call Center

  1 877 822 9493

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2012
• First Posted: July 20, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 11, 2015
• Results First Posted: August 11, 2015

Record last verified: 2015-07

Locations

CN (24)