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Completed

NCT Number: NCT01711866

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 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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

202, Sarawak, Malaysia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotigotine

Drug

Rotigotine up to 16 mg / 24 hours, 4 weeks.

Other names: Neupro

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

UCB BIOSCIENCES GmbH

Industry

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 22, 2012
Registry last updated
Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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