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Completed

NCT Number: NCT00593606

Safety and Tolerability Trial of Switching From Ropinirole to Rotigotine

This is a Phase 3b, open-label, multicenter trial to assess the safety and tolerability of switching from ropinirole therapy to the rotigotine transdermal system and its effect on symptoms in subjects with idiopathic Parkinson's disease

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject is informed and given ample time and opportunity to think about his/her participation in this trial and has given his/her written informed consent.
  • Subject is willing and able to comply with all trial requirements.
  • Subject is male or female, aged≥ 18 years.
  • Subject is Korean.
  • Subjects with idiopathic Parkinson's disease (Hoehn and Yahr Stage I-IV) as defined by the cardinal sign, bradykinesia, and at least 1 of the following: resting tremor, rigidity, or impairment of postural reflexes.
  • Subject is not satisfactorily controlled on a total daily dose of ropinirole from 3mg to 12mg, inclusive.
  • If the subject is receiving levodopa, either short-acting or sustained-release (in combination with benserazide or carbidopa), the total daily dose must be stable for 28 days prior to the Baseline Visit and must remain stable for the Treatment Period.
  • If the subject is receiving an anticholinergic agent (eg, benztropine, trihexyphenidyl, parsitan, procyclidine, biperiden), a monoamine oxidase B (MAO-B) inhibitor (eg, selegiline), a COMT inhibitor (eg, entacapone), or an N-methyl-d-aspartate (NMDA)-antagonist (eg, 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 Treatment Period

Exclusion criteria

Subjects are not permitted to enroll in the trial if any of the following criteria are met:

  • Subject has previously participated in a trial with rotigotine.
  • Subject has participated in another trial of an investigational drug within 28 days prior to the Baseline Visit or is currently participating in another trial of an investigational drug.
  • Subject has atypical Parkinsonian syndrome(s), including drug-induced Parkinsonian syndrome(s).
  • Subject has dementia, active psychosis, or hallucinations (not due to antiparkinsonian medication).
  • Subject is receiving therapy with 1 of the following drugs either concurrently or within 28 days prior to Baseline Visit: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, quetiapine), monoamine oxidase A (MAO-A) inhibitors, methylphenidate, or amphetamine.
  • Subject is currently receiving central nervous system (CNS) active therapy (eg, sedatives, hypnotics, antidepressants, anxiolytics), unless the dose has been stable for at least 28 days prior to the Baseline Visit and is likely to remain stable for the duration of the trial.
  • Subject has a history of seizures or stroke within 1 year, has had a Transient Ischemic Attack (TIA) within 12 months prior to enrollment, or a history of myocardial infarction within the last 6 months prior to enrollment.
  • Presence of clinically relevant hepatic dysfunction.
  • Presence of clinically relevant renal dysfunction.
  • Evidence of clinically relevant cardiovascular disorders.
  • Subject has a QTcB interval of ≥ 500ms at Pretreatment or Baseline (repeated measurements within 1 hour).
  • Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension in the 6 months prior to Baseline.
  • Subject has a history of significant skin hypersensitivity to adhesive or other transdermals or recent unresolved contact dermatitis.
  • Subject has malignant neoplastic disease requiring therapy within 12 months prior to enrollment.
  • Subject has a history of chronic alcohol or drug abuse within the last 6 months.
  • Subject has taken herbal medicine therapy within the last 2 weeks prior to the Baseline Visit.
  • Subject has clinically significant laboratory results that, in the judgment of the investigator, would make the subject unsuitable for entry into the trial.
  • 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 evidence of an impulse control disorder according to the Jay Modified Minnesota Impulsive Disorders Interview (mMIDI) at Pretreatment (Visit 1).
  • Subject has any other clinically significant medical or psychiatric condition that would, in the judgment of the investigator, interfere with the subject's ability to participate in this trial.

Treatment and study plan

Rotigotine

Drug

Strength: 2,4,6,and 8mg/24h, form: transdermal application, once daily application

Other names: Neupro

Primary outcomes

  1. Change in Pulse Rate (Supine, After 1 Minute)

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  2. Change in Systolic Blood Pressure (Supine, After 1 Minute)

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  3. Change in Diastolic Blood Pressure (Supine, After 1 Minute)

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  4. Change in Pulse Rate (Supine, After 5 Minutes)

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  5. Change in Systolic Blood Pressure (Supine, After 5 Minutes)

    Time frame: Baseline, 28 Days

    Change = 28 day value minus baseline value.

  6. Change in Diastolic Blood Pressure (Supine, After 5 Minutes)

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  7. Change in Pulse Rate (Standing, After 1 Minute)

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  8. Change in Systolic Blood Pressure (Standing, After 1 Minute)

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  9. Change in Diastolic Blood Pressure (Standing, After 1 Minute)

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  10. Change in Pulse Rate (Standing, After 3 Minutes)

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  11. Change in Systolic Blood Pressure (Standing, After 3 Minutes)

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  12. Change in Diastolic Blood Pressure (Standing, After 3 Minutes)

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  13. Change in Heart Rate

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  14. Change in PR Interval

    Time frame: Baseline, 28 days

    The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization (beginning of the QRS complex).

    Change = 28 day value minus baseline value.

  15. Change in QRS Duration

    Time frame: Baseline, 28 days

    The QRS duration represents the time it takes for ventricular depolarization to occur.

    Change = 28 day value minus baseline value.

  16. Change in QT Interval

    Time frame: Baseline, 28 days

    The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization.

    Change = 28 day value minus baseline value.

  17. Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB)

    Time frame: Baseline, 28 days

    The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization.

    Change = 28 day value minus baseline value.

  18. Change in Percentage of Basophilic Granulocytes in White Blood Cell Count

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  19. Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  20. Change in Hematocrit

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  21. Change in Hemoglobin

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  22. Change in Percentage of Lymphocytes in White Blood Cell Count

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  23. Change in Percentage of Monocytes in White Blood Cell Count

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  24. Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  25. Change in Platelet Count

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  26. Change in Red Blood Cell Count

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  27. Change in White Blood Cell Count

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  28. Change in Albumin

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  29. Change in Alkaline Phosphatase

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  30. Change in Blood Urea Nitrogen

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  31. Change in Calcium

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  32. Change in Chloride

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  33. Change in Creatinine

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  34. Change in Gamma-Glutamyltransferase

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  35. Change in Glucose

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  36. Change in Inorganic Phosphate

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  37. Change in Potassium

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  38. Change in Serum Glutamic Oxaloacetic Transaminase

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  39. Change in Glutamic Pyruvic Transaminase

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  40. Change in Sodium

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  41. Change in Total Bilirubin

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  42. Change in Total Protein

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  43. Change in Uric Acid

    Time frame: Baseline, 28 days

    Change = 28 day value minus baseline value.

  44. Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Ears, Eyes, Nose, Mouth, Throat'

    Time frame: 28 days

  45. Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Psychiatric'

    Time frame: 28 days

  46. Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hematological/Lymphatic Nodes'

    Time frame: 28 days

  47. Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Dermatological'

    Time frame: 28 days

  48. Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Cardiovascular'

    Time frame: 28 days

  49. Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Peripheral Vascular'

    Time frame: 28 days

  50. Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Pulmonary'

    Time frame: 28 days

  51. Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Musculoskeletal'

    Time frame: 28 days

  52. Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hepato-/Gastrointestinal'

    Time frame: 28 days

  53. Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Renal/Genitourological'

    Time frame: 28 days

  54. Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Metabolic/Endocrine'

    Time frame: 28 days

  55. Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Other'

    Time frame: 28 days

  56. Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Mental Status'

    Time frame: 28 days

  57. Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Deep Tendon Reflexes'

    Time frame: 28 days

  58. Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Muscle Strength'

    Time frame: 28 days

  59. Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Cranial Nerve Function'

    Time frame: 28 days

  60. Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Plantar Reflex'

    Time frame: 28 days

  61. Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Gait'

    Time frame: 28 days

  62. Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Coordination/Balance'

    Time frame: 28 days

  63. Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Involuntary Movements'

    Time frame: 28 days

  64. Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Sensory Perception'

    Time frame: 28 days

  65. Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Other'

    Time frame: 28 days

  66. Completion of Trial From Baseline to End of Treatment

    Time frame: Baseline, 28 days

  67. Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment

    Time frame: Baseline, 28 days

  68. Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs)

    Time frame: Baseline, 2 days

  69. Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period

    Time frame: Baseline, 56 days

  70. Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs)

    Time frame: Baseline, 2 days

  71. Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period

    Time frame: Baseline, 56 days

Secondary outcomes

  1. Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment

    Time frame: Baseline, 28 days

    The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part I measures 'Mentation, Behavior and Mood'. Range: 0 (Best score possible) to 16 (Worst score possible) Change = 28 day value minus baseline value.

  2. Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment

    Time frame: Baseline, 28 days

    The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part II measures 'Activities in Daily Living'. Range: 0 (Best score possible) to 52 (Worst score possible) Change = 28 day value minus baseline value.

  3. Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment

    Time frame: Baseline, 28 days

    The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part III measures 'Motor Examination'. Range: 0 (Best score possible) to 56 (Worst score possible) Change = 28 day value minus baseline value.

  4. Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score From Baseline to End of Treatment

    Time frame: Baseline, 28 days

    The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part IV measures 'Complications of Therapy'. Range: 0 (Best score possible) to 23 (Worst score possible) Change = 28 day value minus baseline value.

  5. Change in Parkinson's Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment

    Time frame: Baseline, 28 days

    The PDSS is a scale to assess sleep and nocturnal disability in Parkinson's disease.

    Range: 0 (Best score possible) to 60 (Worst score possible) Change = 28 day value minus baseline value.

  6. Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment

    Time frame: Baseline, 28 days

    The ESS is a self-administered questionnaire in which the subject rates the probability of his/her dozing during 8 situations that are differently conductive to sleep Range: 0 (Best score possible) to 24 (Worst score possible) Change = 28 day value minus baseline value.

  7. Change in Parkinson's Disease Non-Motor Symptom Assessment Scale (PDNMS) Total Sum Score From Baseline to End of Treatment

    Time frame: Baseline, 28 days

    The PDNMS is a rating by the clinician to assess the severity and frequency of non-motor symptoms in Parkinson's disease patients Range: 0 (Best score possible) to 384 (Worst score possible) Change = 28 day value minus baseline value.

  8. Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment

    Time frame: Baseline, 28 days

    The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.

    Item 1 measures 'Severity of Parkinson's Disease'. Range: 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients) Change = 28 day value minus baseline value.

  9. Clinical Global Impression (CGI) Item 2 Score

    Time frame: 28 days

    The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.

    Item 2 measures 'Global Improvement'. Range 1 (Very much improved) to 7 (Very much worse)

  10. Clinical Global Impression (CGI) Item 3.1

    Time frame: 28 days

    The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.

    Item 3.1 measures 'Therapeutic Effect'. Range: 1 (Marked - Vast improvement. Complete or nearly complete remission of all symptoms.) to 4 (Unchanged or worse)

  11. Clinical Global Impression (CGI) Item 3.2

    Time frame: 28 days

    The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.

    Item 3.2 measures 'Therapeutic Side Effects'. Range: 1 (None) to 4 (Outweigh the therapeutic effect)

  12. Patient Global Impression (PGI) Item 1 Score

    Time frame: 28 days

    The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.

    Item 1 measures 'Global Improvement'. Range: 1 (Very much improved) to 7 (Very much worse)

  13. Patient Global Impression (PGI) Item 2

    Time frame: 28 days

    The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.

    Item 2 measures 'Therapeutic Effect'. Range: 1 (Marked - Vast improvement. Complete or nearly complete remission of all symptoms) to 4 (Unchanged or worse)

  14. Patient Global Impression (PGI) Item 3

    Time frame: 28 days

    The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.

    Item 3 measures 'Side Effects'. Range: 1 (I have no side effects) to 4 (They outweigh the therapeutic effect of the trial medication)

  15. Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment

    Time frame: Baseline, 28 days

    The PDQ-8 is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease.

    Range: 0 (good health) to 100 (poor health) Change = 28 day value minus baseline value.

  16. Patient Treatment Preference Scale Question 1

    Time frame: 28 days

    Have you used pharmaceutical treatments for your Parkinson's disease before the study?

  17. Patient Treatment Preference Scale Question 2

    Time frame: 28 days

    Why did you decide to enter this study?

  18. Patient Treatment Preference Scale Question 3

    Time frame: 28 days

    In comparing the patch and previous oral treatments for Parkinson's disease, how satisfied have you been with oral medication / patch?

  19. Patient Treatment Preference Scale Question 4

    Time frame: 28 days

    I would prefer using a patch over taking a pill or capsule for treatment of my Parkinson's disease.

  20. Patient Treatment Preference Scale Question 5

    Time frame: 28 days

    I would prefer applying one 40cm**2 patch over applying two 20cm**2 patches for treatment of my Parkinson's disease.

  21. Patient Treatment Preference Scale Question 6

    Time frame: 28 days

    What aspects do you like the most about the patch?

  22. Patient Treatment Preference Scale Question 7

    Time frame: 28 days

    What aspects do you like the least about the patch? Check all that apply.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Phase 3b, Open-Label, Multicenter Trial to Assess the Safety and Tolerability of Switching Korean Subjects From Ropinirole to the Rotigotine Transdermal System and Its Effect on Symptoms in Idiopathic Parkinson's Disease

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 15, 2008
Registry last updated
Oct 2, 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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