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Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01300819
First received: February 18, 2011
Last updated: December 6, 2012
Last verified: December 2012
History of Changes

February 18, 2011
December 6, 2012
February 2011
October 2012   (final data collection date for primary outcome measure)
Change from Baseline to the end of Maintenance in total non motor symptom scale (NMSS) score [ Time Frame: From Baseline to end of 12-week Maintenance ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01300819 on ClinicalTrials.gov Archive Site
  • Change from Baseline to the end of Maintenance in total Unified Parkinson's Disease Rating Scale (UPDRS) Part III score [ Time Frame: From Baseline to end of 12-week Maintenance ] [ Designated as safety issue: No ]
  • Change from Baseline to the end of Maintenance in health-related quality of life (HRQL) measured by a 39-item Parkinson's Disease Questionnaire (PDQ39). [ Time Frame: From Baseline to end of 12-week Maintenance ] [ Designated as safety issue: No ]
  • Change from Baseline to the end of Maintenance in the non-motor symptoms scale score: subdomain Cardiovascular. [ Time Frame: From Baseline to end of 12-week Maintenance ] [ Designated as safety issue: No ]
  • Change from Baseline to the end of Maintenance in the non-motor symptoms scale score: subdomain sleep/fatigue [ Time Frame: From Baseline to end of 12-week Maintenance ] [ Designated as safety issue: No ]
  • Change from Baseline to the end of Maintenance in the non-motor symptoms scale score: subdomain mood/cognition [ Time Frame: From Baseline to end of 12-week Maintenance ] [ Designated as safety issue: No ]
  • Change from Baseline to the end of Maintenance in the non-motor symptoms scale score: subdomain perception/hallucinations [ Time Frame: From Baseline to end of 12-week Maintenance ] [ Designated as safety issue: No ]
  • Change from Baseline to the end of Maintenance in the non-motor symptoms scale score: subdomain attention/memory, [ Time Frame: From Baseline to end of 12-week Maintenance ] [ Designated as safety issue: No ]
  • Change from Baseline to the end of Maintenance in the non-motor symptoms scale score: subdomain gastrointestinal tract [ Time Frame: From Baseline to end of 12-week Maintenance ] [ Designated as safety issue: No ]
  • Change from Baseline to the end of Maintenance in the non-motor symptoms scale score: subdomain urinary [ Time Frame: From Baseline to end of 12-week Maintenance ] [ Designated as safety issue: No ]
  • Change from Baseline to the end of Maintenance in the non-motor symptoms scale score: subdomain sexual function [ Time Frame: From Baseline to end of 12-week Maintenance ] [ Designated as safety issue: No ]
  • Change from Baseline to the end of Maintenance in the non-motor symptoms scale score: subdomain miscellaneous [ Time Frame: From Baseline to end of 12-week Maintenance period ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms
Multicenter, Double-blind, Placebo-controlled, Parallel-group, Phase IV Study to Assess the Effect of Rotigotine on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease

The primary objective of this study is to demonstrate that rotigotine improves non-motor symptoms compared to placebo in subjects with Parkinson's disease.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Idiopathic Parkinson's Disease
  • Drug: Placebo

    Placebo patches of 2, 4, 6 & 8 mg/24h Daily application of placebo patches starting at 2 mg/24h (early PD patients) or 4 mg/24h (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg/24h until optimal or maximal dose is reached. Maximal dose is 8 mg/24h for early PD patients and 16 mg/24h for advanced PD patients.

    Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg/24h every other day.

  • Drug: Rotigotine

    Rotigotine patches of 2, 4, 6, and 8 mg/24h

    Once daily application of rotigotine patches starting at 2 mg/24h (early PD patients) or 4 mg/24h (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg/24h until optimal or maximal dose is reached. Maximal dose is 8 mg/24h for early PD patients and 16 mg/24h for advanced PD patients.

    Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg/24h every other day.

    Other Name: Neupro®
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Rotigotine
    Intervention: Drug: Rotigotine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
349
November 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is male or female, ≥18 years of age
  • Subject has idiopathic Parkinson's disease with at least 2 of the following cardinal signs being present: bradykinesia, resting tremor, rigidity or postural instability, and without any other known or suspected cause of Parkinsonism
  • Subject has a Hoehn and Yahr stage score ≤4
  • Subject has a total NMSS score ≥40
  • If the subject is taking levodopa (L-DOPA), he/she must be on a stable dose of L-DOPA (in combination with benserazide or carbidopa) for at least 28 days prior to the Baseline Visit
  • If the subject is receiving anticholinergics, monoamine oxidase (MAO) B inhibitors, or amantadine, he/she must have been on a stable dose for at least 28 days prior to the Baseline Visit and must be maintained on that dose for the duration of the study

Exclusion Criteria:

  • Subject discontinued from previous therapy with a dopamine agonist after an adequate length of treatment, at an adequate dose, due to lack of efficacy as assessed by the investigator
  • Subject is receiving therapy with 1 of the following drugs, either concurrently or within 28 days prior to the Baseline Visit: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, and quetiapine), MAO-A inhibitors, methylphenidate, amphetamine, or other dopamine agonists (DAs)
  • Subject is receiving central nervous system (CNS) therapy (eg, sedatives, hypnotics, selective serotonin reuptake inhibitors [SSRIs], anxiolytics, or other sleep-modifying medication) unless dose has been stable daily for at least 28 days prior to the Baseline Visit and is likely to remain stable for the duration of the study
  • Subject has evidence of an impulse control disorder according to the modified Minnesota Impulsive Disorders Interview at the Screening Visit (Visit 1), confirmed by a positive structured clinical interview
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Bulgaria,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Romania,   Slovakia,   Spain,   Switzerland
 
NCT01300819
SP0976, 2010-021394-37
No
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP