Safety and Tolerability Trial of Switching From Ropinirole to Rotigotine

NCT00593606 | Completed Phase 3 Results

• 1 other identifier: SP0908
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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

Conditions

Parkinson's Disease

Keywords

Rotigotine; NEUPRO; Switching trial from ropinirole to rotigotine,; safety and tolerability; Parkinson disease

Outcome Measures

Primary Outcomes (71)

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

  Change = 28 day value minus baseline value.

  Baseline, 28 days

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

  Change = 28 day value minus baseline value.

  Baseline, 28 days

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

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Pulse Rate (Supine, After 5 Minutes)

  Change = 28 day value minus baseline value.

  Baseline, 28 days

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

  Change = 28 day value minus baseline value.

  Baseline, 28 Days

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

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Pulse Rate (Standing, After 1 Minute)

  Change = 28 day value minus baseline value.

  Baseline, 28 days

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

  Change = 28 day value minus baseline value.

  Baseline, 28 days

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

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Pulse Rate (Standing, After 3 Minutes)

  Change = 28 day value minus baseline value.

  Baseline, 28 days

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

  Change = 28 day value minus baseline value.

  Baseline, 28 days

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

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Heart Rate

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in PR Interval

  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.

  Baseline, 28 days

• Change in QRS Duration

  The QRS duration represents the time it takes for ventricular depolarization to occur. Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in QT Interval

  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.

  Baseline, 28 days

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

  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.

  Baseline, 28 days

• Change in Percentage of Basophilic Granulocytes in White Blood Cell Count

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Hematocrit

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Hemoglobin

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Percentage of Lymphocytes in White Blood Cell Count

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Percentage of Monocytes in White Blood Cell Count

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Platelet Count

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Red Blood Cell Count

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in White Blood Cell Count

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Albumin

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Alkaline Phosphatase

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Blood Urea Nitrogen

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Calcium

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Chloride

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Creatinine

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Gamma-Glutamyltransferase

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Glucose

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Inorganic Phosphate

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Potassium

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Serum Glutamic Oxaloacetic Transaminase

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Glutamic Pyruvic Transaminase

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Sodium

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Total Bilirubin

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Total Protein

  Change = 28 day value minus baseline value.

  Baseline, 28 days

• Change in Uric Acid

  Change = 28 day value minus baseline value.

  Baseline, 28 days

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

  28 days

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

  28 days

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

  28 days

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

  28 days

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

  28 days

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

  28 days

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

  28 days

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

  28 days

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

  28 days

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

  28 days

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

  28 days

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

  28 days

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

  28 days

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

  28 days

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

  28 days

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

  28 days

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

  28 days

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

  28 days

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

  28 days

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

  28 days

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

  28 days

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

  28 days

• Completion of Trial From Baseline to End of Treatment

  Baseline, 28 days

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

  Baseline, 28 days

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

  Baseline, 2 days

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

  Baseline, 56 days

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

  Baseline, 2 days

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

  Baseline, 56 days

Secondary Outcomes (22)

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

  Baseline, 28 days

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

  Baseline, 28 days

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

  Baseline, 28 days

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

  Baseline, 28 days

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

  Baseline, 28 days

Study Arms (1)

Rotigotine

EXPERIMENTAL

Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.

Drug: Rotigotine

Interventions

Rotigotine DRUG

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

Also known as: Neupro

Rotigotine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• UCB Pharma: lead

Related Publications (1)

• 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.

  PMID: 21831297 RESULT

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Parkinson Disease

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB

+1 877 822 9493

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 15, 2008
• Study Start: July 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: October 2, 2014
• Results First Posted: May 27, 2009

Record last verified: 2011-10