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

NCT01646255 | Completed Phase 3 Results

• 1 other identifier: SP1037
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 24

Brief Summary

The primary objective of this study was to demonstrate that Rotigotine transdermal patch is efficacious in Chinese subjects with advanced-stage Idiopathic Parkinson's Disease as an adjuvant therapy.

Conditions

Idiopathic Parkinson's Disease

Keywords

Rotigotine; Neupro phase 3; Advanced-stage; Idiopathic Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period

  A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. A negative mean indicates a reduction of the time off during the conduct of the study

  From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Secondary Outcomes (12)

• Percentage of Responders From Baseline to the End of the Doubleblind Maintenance Period

  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

  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

  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

  From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

• Change in Relative Time Spent "on" From Baseline to the End of Double-blind Maintenance Period

  From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Study Arms (2)

Rotigotine

EXPERIMENTAL

Rotigotine, daily doses, treatment group

Drug: Rotigotine; Drug: L-dopa

Placebo

PLACEBO COMPARATOR

Placebo, daily doses, placebo group

Drug: Placebo Patch; Drug: L-dopa

Interventions

Rotigotine DRUG

Transdermal Patch Content: 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2) For advanced-stage Parkinson's Disease, subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 4 mg/24 h to 16 mg/24 h) for a maximum 7-week Titration Period, then 12 week maintenance period

Rotigotine

Placebo Patch DRUG

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

Placebo

L-dopa DRUG

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.

Also known as: Levodopa

Placebo; Rotigotine

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 (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

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 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)

Sponsors & Collaborators

• UCB Pharma: lead
• UCB Trading (Shanghai) Co. Ltd.: collaborator

Study Sites (24)

Sp1037 001

Beijing, China

Location

Sp1037 002

Beijing, China

Location

Sp1037 019

Beijing, China

Location

Sp1037 025

Beijing, China

Location

Sp1037 017

Changchun, China

Location

Sp1037 007

Chengdu, China

Location

Sp1037 027

Chengdu, China

Location

Sp1037 021

Fuzhou, China

Location

Sp1037 010

Guangzhou, China

Location

Sp1037 011

Guangzhou, China

Location

Sp1037 014

Guangzhou, China

Location

Sp1037 015

Guangzhou, China

Location

Sp1037 005

Hangzhou, China

Location

Sp1037 013

Hangzhou, China

Location

Sp1037 018

Hangzhou, China

Location

Sp1037 023

Jinan, China

Location

Sp1037 003

Shanghai, China

Location

Sp1037 004

Shanghai, China

Location

Sp1037 009

Shanghai, China

Location

Sp1037 008

Suzhou, China

Location

Sp1037 016

Tianjin, China

Location

Sp1037 006

Wuhan, China

Location

Sp1037 022

Wuhan, China

Location

Sp1037 024

Wuhan, China

Location

Related Publications (1)

• Zhang ZX, Liu CF, Tao EX, Shao M, Liu YM, Wang J, Asgharnejad M, Xue HB, Surmann E, Bauer L. Rotigotine transdermal patch in Chinese patients with advanced Parkinson's disease: A randomized, double-blind, placebo-controlled pivotal study. Parkinsonism Relat Disord. 2017 Nov;44:6-12. doi: 10.1016/j.parkreldis.2017.08.015. Epub 2017 Aug 10.

  PMID: 28827011 RESULT

MeSH Terms

Conditions

Parkinson Disease

Interventions

rotigotine; Levodopa

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Results Point of Contact

• Title: Study Director
• Organization: UCB

+1877 822

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: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 4, 2018
• Results First Posted: January 22, 2016

Record last verified: 2018-03

Locations

CN (24)