Phase 3 N=346 Randomized Double-blind Treatment

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

Idiopathic Parkinson's Disease

Bottom Line

View on ClinicalTrials.gov: NCT01646255 ↗

Enrolled (actual)

346

Serious AEs

3.5%

Results posted

Jan 2016

Primary outcome: Primary: Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period — -1.13; -2.36 hours — p==0.0002

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Rotigotine (Drug); Placebo Patch (Drug); L-dopa (Drug)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: UCB Pharma
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period	-1.13; -2.36	=0.0002 sig
SECONDARY Percentage of Responders From Baseline to the End of the Doubleblind Maintenance Period	36.9; 48.8	—
SECONDARY Percent Change in Absolute Time Spent "Off" From Baseline to the End of Double-blind Maintenance Period	-15.0; -36.03	—
SECONDARY Percent Change in Relative Time Spent "Off" From Baseline to the End of Double-blind Maintenance Period	-14.86; -34.97	—
SECONDARY Change in Absolute Time Spent "on" From Baseline to the End of Double-blind Maintenance Period	0.94; 2.05	—
SECONDARY Change in Relative Time Spent "on" From Baseline to the End of Double-blind Maintenance Period	6.78; 14.49	—
SECONDARY Percent Change in Absolute Time Spent "on" From Baseline to the End of Double-blind Maintenance Period	13.53; 368.55	—
SECONDARY Percent Change in Relative Time Spent "on" From Baseline to the End of Double-blind Maintenance Period	14.99; 616.80	—
SECONDARY Change in the Number of "Off" Periods From Baseline to the End of Double-blind Maintenance Period	-0.61; -0.89	—
SECONDARY Change in Status of the Subject (on) After Wake-up With Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period	2.42; 1.24	—
SECONDARY Change in Status of the Subject (on) After Wake-up Without Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period	7.92; 22.55	—
SECONDARY Change in Status of the Subject (Off) After Wake-up From Baseline to the End of Double-blind Maintenance Period	-10.34; -21.14	—
SECONDARY 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	-3.6; -10.4	—

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.

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT01646255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.