Phase 3 Completed N=124 Treatment

Safety and Tolerability Trial of Switching From Ropinirole to Rotigotine

Parkinson's Disease

Source: ClinicalTrials.gov NCT00593606 ↗

Enrolled (actual)

124

Serious AEs

0.0%

Results posted

May 2009

Primary outcomePrimary: Change in Pulse Rate (Supine, After 1 Minute) — 2.0 beats per minute

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pulse Rate (Supine, After 1 Minute)	2.0	—
PRIMARY Change in Systolic Blood Pressure (Supine, After 1 Minute)	5.7	—
PRIMARY Change in Diastolic Blood Pressure (Supine, After 1 Minute)	1.7	—
PRIMARY Change in Pulse Rate (Supine, After 5 Minutes)	1.8	—
PRIMARY Change in Systolic Blood Pressure (Supine, After 5 Minutes)	2.6	—
PRIMARY Change in Diastolic Blood Pressure (Supine, After 5 Minutes)	0.6	—
PRIMARY Change in Pulse Rate (Standing, After 1 Minute)	1.7	—
PRIMARY Change in Systolic Blood Pressure (Standing, After 1 Minute)	-0.2	—
PRIMARY Change in Diastolic Blood Pressure (Standing, After 1 Minute)	0.8	—
PRIMARY Change in Pulse Rate (Standing, After 3 Minutes)	0.8	—
PRIMARY Change in Systolic Blood Pressure (Standing, After 3 Minutes)	2.0	—
PRIMARY Change in Diastolic Blood Pressure (Standing, After 3 Minutes)	0.8	—
PRIMARY Change in Heart Rate	0.5	—
PRIMARY Change in PR Interval	-0.0	—
PRIMARY Change in QRS Duration	-1.2	—
PRIMARY Change in QT Interval	-1.7	—
PRIMARY Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB)	0.5	—
PRIMARY Change in Percentage of Basophilic Granulocytes in White Blood Cell Count	0.01	—
PRIMARY Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count	-0.11	—
PRIMARY Change in Hematocrit	0.09	—
PRIMARY Change in Hemoglobin	0.8	—
PRIMARY Change in Percentage of Lymphocytes in White Blood Cell Count	0.73	—
PRIMARY Change in Percentage of Monocytes in White Blood Cell Count	0.96	—
PRIMARY Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count	-0.40	—
PRIMARY Change in Platelet Count	2.6	—
PRIMARY Change in Red Blood Cell Count	0.023	—
PRIMARY Change in White Blood Cell Count	-0.045	—
PRIMARY Change in Albumin	-0.5	—
PRIMARY Change in Alkaline Phosphatase	-1.4	—
PRIMARY Change in Blood Urea Nitrogen	-0.24	—
PRIMARY Change in Calcium	-0.05	—
PRIMARY Change in Chloride	-0.4	—
PRIMARY Change in Creatinine	-0.004	—
PRIMARY Change in Gamma-Glutamyltransferase	-0.1	—
PRIMARY Change in Glucose	-0.2	—
PRIMARY Change in Inorganic Phosphate	-0.03	—
PRIMARY Change in Potassium	0.08	—
PRIMARY Change in Serum Glutamic Oxaloacetic Transaminase	-0.1	—
PRIMARY Change in Glutamic Pyruvic Transaminase	-0.2	—
PRIMARY Change in Sodium	-0.6	—
PRIMARY Change in Total Bilirubin	0.079	—
PRIMARY Change in Total Protein	-0.09	—
PRIMARY Change in Uric Acid	-3.80	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Ears, Eyes, Nose, Mouth, Throat'	—	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Psychiatric'	—	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hematological/Lymphatic Nodes'	—	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Dermatological'	1	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Cardiovascular'	—	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Peripheral Vascular'	—	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Pulmonary'	—	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Musculoskeletal'	1	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hepato-/Gastrointestinal'	—	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Renal/Genitourological'	—	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Metabolic/Endocrine'	—	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Other'	—	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Mental Status'	—	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Deep Tendon Reflexes'	—	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Muscle Strength'	—	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Cranial Nerve Function'	—	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Plantar Reflex'	—	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Gait'	1	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Coordination/Balance'	—	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Involuntary Movements'	1	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Sensory Perception'	—	—
PRIMARY Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Other'	—	—
PRIMARY Completion of Trial From Baseline to End of Treatment	99	—
PRIMARY Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment	88	—
PRIMARY Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs)	—	—
PRIMARY Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period	9	—
PRIMARY Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs)	1	—
PRIMARY Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period	1	—
SECONDARY Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment	-0.5	—
SECONDARY Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment	-0.9	—
SECONDARY Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment	-1.9	—
SECONDARY Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score From Baseline to End of Treatment	-0.4	—
SECONDARY Change in Parkinson's Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment	-0.8	—
SECONDARY Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment	-0.2	—
SECONDARY Change in Parkinson's Disease Non-Motor Symptom Assessment Scale (PDNMS) Total Sum Score From Baseline to End of Treatment	-7.9	—
SECONDARY Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment	-0.0	—
SECONDARY Clinical Global Impression (CGI) Item 2 Score	3.6	—
SECONDARY Clinical Global Impression (CGI) Item 3.1	3; 20; 36; 54; 1	—
SECONDARY Clinical Global Impression (CGI) Item 3.2	88; 18; 5; 2; 1	—
SECONDARY Patient Global Impression (PGI) Item 1 Score	3.6	—
SECONDARY Patient Global Impression (PGI) Item 2	5; 25; 38; 44; 2	—
SECONDARY Patient Global Impression (PGI) Item 3	77; 24; 6; 5; 2	—
SECONDARY Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment	-3.9	—
SECONDARY Patient Treatment Preference Scale Question 1	114; 0	—
SECONDARY Patient Treatment Preference Scale Question 2	14; 21; 71; 40	—
SECONDARY Patient Treatment Preference Scale Question 3	3; 11; 49; 43; 6; 2	—
SECONDARY Patient Treatment Preference Scale Question 4	18; 34; 29; 28; 3; 2	—
SECONDARY Patient Treatment Preference Scale Question 5	17; 68; 10; 13; 4; 2	—
SECONDARY Patient Treatment Preference Scale Question 6	81; 28; 61; 56; 46; 53	—
SECONDARY Patient Treatment Preference Scale Question 7	11; 3; 1; 80; 27; 8	—

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 e

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Data sourced from ClinicalTrials.gov (NCT00593606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.