Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00522379
First received: August 28, 2007
Last updated: October 17, 2014
Last verified: December 2012
  Purpose

The purpose of this study is to show Rotigotine dose response at four doses of Rotigotine used with L-dopa in treating advanced stage Parkinson's disease.


Condition Intervention Phase
Parkinson's Disease
Drug: Rotigotine
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, 5-arm, Parallel-group Trial to Assess Rotigotine Transdermal System Dose Response in Subjects With Advanced-stage Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • The Change in the Absolute Time Spent "Off" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ] [ Designated as safety issue: No ]
    Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.


Secondary Outcome Measures:
  • The Change in Relative Time Spent "Off" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ] [ Designated as safety issue: No ]
    Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.

  • The Change in the Absolute Time Spent "on" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ] [ Designated as safety issue: No ]
    Time "On" is defined as when the patient has the effect of anti-Parkinson's medication.

  • The Change in the Relative Time Spent "on" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ] [ Designated as safety issue: No ]
    Time "On" is defined as when the patient has the effect of anti-Parkinson's medication.

  • The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ] [ Designated as safety issue: No ]
  • The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II From Baseline to the End of the Maintenance Period [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ] [ Designated as safety issue: No ]
    The Unified Parkinson's Disease Rating Scale (UPDRS) Part II is a scale for the assessment of function in Parkinson's disease. UPDRS Part II measures Activities of Daily Living. It consists of 13 questions, each ranging from 0 to 4. The sum score of the UPDRS Part II ranges from 0 to 52. A higher score indicates greater disability. A negative change score indicates improvement.

  • The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III From Baseline to the End of the Maintenance Period [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ] [ Designated as safety issue: No ]
    The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a scale for the assessment of function in Parkinson's disease. UPDRS Part III measures Motor Function. It consists of 14 items with 27 questions, each ranging from 0 to 4. The sum score for the UPDRS Part III ranges from 0 to 108. A higher score indicates greater disability. A negative change score indicates improvement.

  • The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ] [ Designated as safety issue: No ]

    Item = Duration (question #32) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - What proportion of the waking day are dyskinesias present? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.


  • The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ] [ Designated as safety issue: No ]

    Item = Disability (question #33) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How disabling are the dyskinesias? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.


  • The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ] [ Designated as safety issue: No ]

    Item = Painful Dyskinesia (question #34) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How painful are the dyskinesias? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.


  • The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ] [ Designated as safety issue: No ]

    Item = Presence of Early Morning Dystonia (question #35) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates early morning dystonia.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.


  • The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are "Off" Periods Predictable? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ] [ Designated as safety issue: No ]

    Item = Are "off" periods predictable (question #36) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates "off" periods are predictable.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.


  • The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are "Off" Periods Unpredictable? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ] [ Designated as safety issue: No ]

    Item = Are "off" periods unpredictable (question #37) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates "off" periods are unpredictable.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.


  • The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do "Off" Periods Come on Suddenly? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ] [ Designated as safety issue: No ]

    Item = Do "off" periods come on suddenly, within a few seconds (question #38) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates "off" periods come on suddenly, within a few seconds.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.


  • The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject "Off", on Average? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ] [ Designated as safety issue: No ]

    Item = What proportion of the waking day is the subject "off", on average (question #39) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 - 4 points (4 = maximum). A higher score indicates the subject is "off" a larger portion of the waking day.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.


  • The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ] [ Designated as safety issue: No ]

    Item = Does the patient have anorexia, nausea, or vomiting (question #40) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has anorexia, nausea, or vomiting.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.


  • The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ] [ Designated as safety issue: No ]

    Item = Does the patient have any sleep disturbances such as insomnia or hypersomnolence (question #41) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has sleep disturbances such as insomnia or hypersomnolence.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.


  • The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ] [ Designated as safety issue: No ]

    Item = Does the patient have symptomatic orthostasis (question #42) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has symptomatic orthostasis.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.


  • The Change in Number of "Off" Periods From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ] [ Designated as safety issue: No ]
    Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.


Enrollment: 514
Study Start Date: July 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rotigotine 2 mg/24 hr Drug: Rotigotine
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
Other Name: Neupro
Experimental: Rotigotine 4 mg/24 hr Drug: Rotigotine
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
Other Name: Neupro
Experimental: Rotigotine 6 mg/24 hr Drug: Rotigotine
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
Other Name: Neupro
Experimental: Rotigotine 8 mg/24 hr Drug: Rotigotine
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
Other Name: Neupro
Placebo Comparator: Placebo Other: Placebo
Placebo transdermal patch applied daily

Detailed Description:

To maintain treatment blind, two different active patch sizes were used (10 cm^2 & 20 cm^2). Placebo patches matched according to size and appearance. During the trial subjects applied up to three patches, active and placebo, to achieve their assigned daily dose.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PD greater than 3 years
  • Stable dose L-dopa but symptoms not adequately controlled and have "off" time
  • Able and willing to complete diary on specific days

Exclusion Criteria:

  • Previous use of rotigotine or Neupro
  • Atypical Parkinson's syndrome
  • Pallidotomy
  • Thalamotomy
  • Deep brain stimulation
  • Fetal tissue transplant
  • Dementia
  • Psychosis
  • Hallucinations
  • Epilepsy
  • Renal or hepatic dysfunction
  • Clinically relevant cardiac dysfunction
  • Symptomatic orthostatic hypotension
  • Skin sensitivity to adhesives or unresolved contact dermatitis
  • History of chronic alcohol or drug abuse
  • Pregnant or of child-bearing potential
  • Impulse control disorder
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522379

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States
Tuscaloosa, Alabama, United States
United States, Arizona
Gilbert, Arizona, United States
Peoria, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
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Fountain Valley, California, United States
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Oxnard, California, United States
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New Haven, Connecticut, United States
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Chicago, Illinois, United States
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Kansas City, Kansas, United States
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Louisville, Kentucky, United States
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Southfield, Michigan, United States
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Golden Valley, Minnesota, United States
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St Louis, Missouri, United States
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Missoula, Montana, United States
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Omaha, Nebraska, United States
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Greensburg, Pennsylvania, United States
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Memphis, Tennessee, United States
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Lubbock, Texas, United States
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Midvale, Utah, United States
South Ogden, Utah, United States
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Alexandria, Virginia, United States
Richmond, Virginia, United States
Roanoke, Virginia, United States
Virginia Beach, Virginia, United States
United States, Washington
Kirkland, Washington, United States
Spokane, Washington, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Chile
Santiago de Chile, Chile
India
Hyderbad, Andhra Pradesh, India
Bangalore, Kamataka, India
Mangalore, Kamataka, India
Mysore, Karnataka, India
Calicut, Kerala, India
Thiruvananthapuram, Kerala, India
Indore, Madhya Pradesh, India
Mumbai, Maharashtra, India
Pune, Maharashtra, India
Chennai, Tamil Nadu, India
Mexico
Monterrey, Nuevo Leon, Mexico
Aguascalientes, Mexico
Peru
San Isidro, Lima, Peru
Santiago de Surco, Lima, Peru
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00522379     History of Changes
Other Study ID Numbers: SP0921
Study First Received: August 28, 2007
Results First Received: July 3, 2012
Last Updated: October 17, 2014
Health Authority: United States: Food and Drug Administration
India: Ministry of Health
Peru: Ministry of Health
Chile: Ministry of Health
Mexico: Ministry of Health

Keywords provided by UCB Pharma:
Parkinson's disease
rotigotine
patch
transdermal
dopamine agonist
off time
Neupro

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
N 0437
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014