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

• ClinicalTrials.gov Identifier: NCT00522379
• Recruitment Status: Completed
• First Posted: August 29, 2007
• Results First Posted: December 10, 2012
• Last Update Posted: October 27, 2014
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

Tracking Information

• First Submitted Date: August 28, 2007
• First Posted Date: August 29, 2007
• Results First Submitted Date: July 3, 2012
• Results First Posted Date: December 10, 2012
• Last Update Posted Date: October 27, 2014
• Study Start Date: July 2007
• Actual Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 7, 2012)

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)]. ]

Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.

• Original Primary Outcome Measures (submitted: August 28, 2007): The primary objective of this trial is to show rotigotine dose response (at 2, 4, 6, or 8mg/24h) in subjects with advanced-stage Parkinson's disease. [ Time Frame: 3 Months maintenance period ]

Current Secondary Outcome Measures (submitted: December 7, 2012)

• 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)]. ]
  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)]. ]
  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)]. ]
  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)]. ]
• 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)]. ]
  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)]. ]
  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)]. ]
  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)]. ]
  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)]. ]
  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)]. ]
  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)]. ]
  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)]. ]
  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)]. ]
  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)]. ]
  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)]. ]
  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)]. ]
  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)]. ]
  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)]. ]
  Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.

• Original Secondary Outcome Measures (submitted: August 28, 2007): A secondary objective is to demonstrate the safety and tolerability of rotigotine at these doses. [ Time Frame: 5 Months ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch
• 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
• Brief Summary: 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Parkinson's Disease

Intervention

• Drug: Rotigotine
  2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
  Other Name: Neupro
• Drug: Rotigotine
  4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
  Other Name: Neupro
• Other: Placebo
  Placebo transdermal patch applied daily
• 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
• 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

Study Arms

• Experimental: Rotigotine 2 mg/24 hr
  Intervention: Drug: Rotigotine
• Experimental: Rotigotine 4 mg/24 hr
  Intervention: Drug: Rotigotine
• Experimental: Rotigotine 6 mg/24 hr
  Intervention: Drug: Rotigotine
• Experimental: Rotigotine 8 mg/24 hr
  Intervention: Drug: Rotigotine
• Placebo Comparator: Placebo
  Intervention: Other: Placebo

• Publications *: LeWitt PA, Poewe W, Elmer LW, Asgharnejad M, Boroojerdi B, Grieger F, Bauer L. The Efficacy Profile of Rotigotine During the Waking Hours in Patients With Advanced Parkinson's Disease: A Post Hoc Analysis. Clin Neuropharmacol. 2016 Mar-Apr;39(2):88-93. doi: 10.1097/WNF.0000000000000133.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 11, 2011): 514
• Original Estimated Enrollment (submitted: August 28, 2007): 500
• Actual Study Completion Date: July 2011
• Actual Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Chile, India, Mexico, Peru, United States

Administrative Information

• NCT Number: NCT00522379
• Other Study ID Numbers: SP0921
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: UCB Pharma
• Study Sponsor: UCB Pharma
• Collaborators: Not Provided

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

• PRS Account: UCB Pharma
• Verification Date: December 2012