Clinical trial NCT00593606: Safety and Tolerability Trial of Switching From Ropinirole to Rotigotine
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Rotigotine
NEUPRO
Switching trial from ropinirole to rotigotine,
safety and tolerability
Parkinson disease
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-01-15
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pulse Rate (Supine, After 1 Minute)
timeFrame: Baseline, 28 days
measure: Change in Systolic Blood Pressure (Supine, After 1 Minute)
timeFrame: Baseline, 28 days
measure: Change in Diastolic Blood Pressure (Supine, After 1 Minute)
timeFrame: Baseline, 28 days
measure: Change in Pulse Rate (Supine, After 5 Minutes)
timeFrame: Baseline, 28 days
measure: Change in Systolic Blood Pressure (Supine, After 5 Minutes)
timeFrame: Baseline, 28 Days
measure: Change in Diastolic Blood Pressure (Supine, After 5 Minutes)
timeFrame: Baseline, 28 days
measure: Change in Pulse Rate (Standing, After 1 Minute)
timeFrame: Baseline, 28 days
measure: Change in Systolic Blood Pressure (Standing, After 1 Minute)
timeFrame: Baseline, 28 days
measure: Change in Diastolic Blood Pressure (Standing, After 1 Minute)
timeFrame: Baseline, 28 days
measure: Change in Pulse Rate (Standing, After 3 Minutes)
timeFrame: Baseline, 28 days
measure: Change in Systolic Blood Pressure (Standing, After 3 Minutes)
timeFrame: Baseline, 28 days
measure: Change in Diastolic Blood Pressure (Standing, After 3 Minutes)
timeFrame: Baseline, 28 days
measure: Change in Heart Rate
timeFrame: Baseline, 28 days
measure: Change in PR Interval
timeFrame: Baseline, 28 days
measure: Change in QRS Duration
timeFrame: Baseline, 28 days
measure: Change in QT Interval
timeFrame: Baseline, 28 days
measure: Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB)
timeFrame: Baseline, 28 days
measure: Change in Percentage of Basophilic Granulocytes in White Blood Cell Count
timeFrame: Baseline, 28 days
measure: Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count
timeFrame: Baseline, 28 days
measure: Change in Hematocrit
timeFrame: Baseline, 28 days
measure: Change in Hemoglobin
timeFrame: Baseline, 28 days
measure: Change in Percentage of Lymphocytes in White Blood Cell Count
timeFrame: Baseline, 28 days
measure: Change in Percentage of Monocytes in White Blood Cell Count
timeFrame: Baseline, 28 days
measure: Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count
timeFrame: Baseline, 28 days
measure: Change in Platelet Count
timeFrame: Baseline, 28 days
measure: Change in Red Blood Cell Count
timeFrame: Baseline, 28 days
measure: Change in White Blood Cell Count
timeFrame: Baseline, 28 days
measure: Change in Albumin
timeFrame: Baseline, 28 days
measure: Change in Alkaline Phosphatase
timeFrame: Baseline, 28 days
measure: Change in Blood Urea Nitrogen
timeFrame: Baseline, 28 days
measure: Change in Calcium
timeFrame: Baseline, 28 days
measure: Change in Chloride
timeFrame: Baseline, 28 days
measure: Change in Creatinine
timeFrame: Baseline, 28 days
measure: Change in Gamma-Glutamyltransferase
timeFrame: Baseline, 28 days
measure: Change in Glucose
timeFrame: Baseline, 28 days
measure: Change in Inorganic Phosphate
timeFrame: Baseline, 28 days
measure: Change in Potassium
timeFrame: Baseline, 28 days
measure: Change in Serum Glutamic Oxaloacetic Transaminase
timeFrame: Baseline, 28 days
measure: Change in Glutamic Pyruvic Transaminase
timeFrame: Baseline, 28 days
measure: Change in Sodium
timeFrame: Baseline, 28 days
measure: Change in Total Bilirubin
timeFrame: Baseline, 28 days
measure: Change in Total Protein
timeFrame: Baseline, 28 days
measure: Change in Uric Acid
timeFrame: Baseline, 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Ears, Eyes, Nose, Mouth, Throat'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Psychiatric'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hematological/Lymphatic Nodes'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Dermatological'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Cardiovascular'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Peripheral Vascular'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Pulmonary'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Musculoskeletal'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hepato-/Gastrointestinal'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Renal/Genitourological'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Metabolic/Endocrine'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Other'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Mental Status'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Deep Tendon Reflexes'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Muscle Strength'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Cranial Nerve Function'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Plantar Reflex'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Gait'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Coordination/Balance'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Involuntary Movements'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Sensory Perception'
timeFrame: 28 days
measure: Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Other'
timeFrame: 28 days
measure: Completion of Trial From Baseline to End of Treatment
timeFrame: Baseline, 28 days
measure: Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment
timeFrame: Baseline, 28 days
measure: Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs)
timeFrame: Baseline, 2 days
measure: Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period
timeFrame: Baseline, 56 days
measure: Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs)
timeFrame: Baseline, 2 days
measure: Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period
timeFrame: Baseline, 56 days
Secondary outcomes:
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment
timeFrame: Baseline, 28 days
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment
timeFrame: Baseline, 28 days
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment
timeFrame: Baseline, 28 days
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score From Baseline to End of Treatment
timeFrame: Baseline, 28 days
measure: Change in Parkinson's Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment
timeFrame: Baseline, 28 days
measure: Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment
timeFrame: Baseline, 28 days
measure: Change in Parkinson's Disease Non-Motor Symptom Assessment Scale (PDNMS) Total Sum Score From Baseline to End of Treatment
timeFrame: Baseline, 28 days
measure: Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment
timeFrame: Baseline, 28 days
measure: Clinical Global Impression (CGI) Item 2 Score
timeFrame: 28 days
measure: Clinical Global Impression (CGI) Item 3.1
timeFrame: 28 days
measure: Clinical Global Impression (CGI) Item 3.2
timeFrame: 28 days
measure: Patient Global Impression (PGI) Item 1 Score
timeFrame: 28 days
measure: Patient Global Impression (PGI) Item 2
timeFrame: 28 days
measure: Patient Global Impression (PGI) Item 3
timeFrame: 28 days
measure: Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment
timeFrame: Baseline, 28 days
measure: Patient Treatment Preference Scale Question 1
timeFrame: 28 days
measure: Patient Treatment Preference Scale Question 2
timeFrame: 28 days
measure: Patient Treatment Preference Scale Question 3
timeFrame: 28 days
measure: Patient Treatment Preference Scale Question 4
timeFrame: 28 days
measure: Patient Treatment Preference Scale Question 5
timeFrame: 28 days
measure: Patient Treatment Preference Scale Question 6
timeFrame: 28 days
measure: Patient Treatment Preference Scale Question 7
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Kim HJ, Jeon BS, Lee WY, Lee MC, Kim JW, Kim JM, Ahn TB, Cho J, Chung SJ, Grieger F, Whitesides J, Boroojerdi B. Overnight switch from ropinirole to transdermal rotigotine patch in patients with Parkinson disease. BMC Neurol. 2011 Aug 10;11:100. doi: 10.1186/1471-2377-11-100.