Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01711866
Previous Study | Return to List | Next Study

A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01711866
Recruitment Status : Completed
First Posted : October 22, 2012
Results First Posted : April 7, 2014
Last Update Posted : April 7, 2014
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )

Brief Summary:
The purpose of this study is to assess the safety and feasibility of switching subjects with advanced Parkinson's Disease (PD) from Pramipexole or Ropinirole to Rotigotine and to assess the effects of Rotigotine on motor and non-motor symptoms of Parkinson's Disease in subjects switched from previous treatment with either Pramipexole or Ropinirole.

Condition or disease Intervention/treatment Phase
Advanced Idiopathic Parkinson's Disease Drug: Rotigotine Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Multinational Study to Assess the Feasibility of Switching Therapy From Pramipexole or Ropinirole to the Rotigotine Transdermal System and Its Effect on Motor and Non-Motor Symptoms in Subjects With Advanced Idiopathic Parkinson's Disease Phase 4
Study Start Date : September 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rotigotine

First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.

  • Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.
  • Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.
Drug: Rotigotine
Rotigotine up to 16 mg / 24 hours, 4 weeks.
Other Name: Neupro




Primary Outcome Measures :
  1. Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit [ Time Frame: Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit ]

    The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows:

    • 0 = Side effects not assessable
    • 1 = No side effects
    • 2 = Side effects do not significantly interfere with subject's functioning
    • 3 = Side effects significantly interfere with the subject's functioning
    • 4 = Side effects outweigh therapeutic efficacy.


Secondary Outcome Measures :
  1. Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit [ Time Frame: Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit ]

    The PGIC is a 7-point categorical rating scale in which the subject rates the changes in functioning over time as follows:

    • 1 = Very much improved
    • 2 = Much improved
    • 3 = Minimally improved
    • 4 = No change
    • 5 = Minimally worse
    • 6 = Much worse
    • 7 = Very much worse.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has idiopathic Parkinson's Disease of more than 3 years duration, as defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor, rigidity, impairment of postural reflexes and is without any other known or suspected cause of Parkinsonism
  • Subject has motor fluctuations
  • Subject is not satisfactorily controlled following the investigator´s assessment on a total daily dose of Pramipexole or Ropinirole
  • Subject has sleep disturbance or early morning motor impairment
  • Subject has experienced nocturia for at least 3 nights within 7 days prior to the Baseline Visit
  • Subject is taking L-dopa in combination with Benserazide or Carbidopa and has been on a stable dose of L-dopa for at least 28 days prior to the Baseline Visit

Exclusion Criteria:

  • Subject has had therapy with Tolcapone or Budipine
  • Subject is receiving therapy with one of the following drugs either concurrently or within 28 days prior to Baseline (Visit 2): alpha-methyl dopa, metoclopramide, reserpine, neuroleptics, monoamine oxidase A (MAO-A) inhibitors, methylphenidate, or amphetamine
  • Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension in the 6 months prior to Baseline (Visit 2)
  • Subject has a history of significant skin hypersensitivity to adhesive or other transdermal preparations, or recent unsolved contact dermatitis
  • Subject has a history of seizures or stroke within 1 year, or a history of myocardial infarction within the last 6 months prior to enrollment
  • 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 1 barrier method) or (iii) not sexually abstinent or (iv) not at least 2 years postmenopausal
  • Subject has a previous diagnosis of narcolepsy, sleep apnea syndrome, restless legs syndrome, or periodic limb movement disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711866


Locations
Show Show 21 study locations
Sponsors and Collaborators
UCB BIOSCIENCES GmbH
Otsuka Pharmaceutical Co., Ltd.
Investigators
Layout table for investigator information
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: UCB BIOSCIENCES GmbH
ClinicalTrials.gov Identifier: NCT01711866    
Other Study ID Numbers: PD0009
First Posted: October 22, 2012    Key Record Dates
Results First Posted: April 7, 2014
Last Update Posted: April 7, 2014
Last Verified: February 2014
Keywords provided by UCB Pharma ( UCB BIOSCIENCES GmbH ):
Rotigotine
Neupro
Switch
Dopamine agonists
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs