Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction
NCT ID: NCT01536015
Last Updated: 2014-08-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
25 participants
INTERVENTIONAL
2012-01-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rotigotine
Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.
Rotigotine
Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours
Dosage and Frequency: One patch every 24 hours
Duration: 10 weeks
Placebo
Placebo patch.
Placebo
Frequency: One patch applied every 24 hours
Duration: 10 weeks
Interventions
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Rotigotine
Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours
Dosage and Frequency: One patch every 24 hours
Duration: 10 weeks
Placebo
Frequency: One patch applied every 24 hours
Duration: 10 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is willing and able to comply with all study requirements (protocol, visit schedule, procedures, and medication application)
* Subject is male or female and ≥ 30 years of age
* Subject has Idiopathic Parkinson's Disease of more than 3 years duration, as defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor, rigidity, impairment of postural reflexes; and is without any other known or suspected cause of Parkinsonism
* Subject has a Hoehn \& Yahr stage score II through IV
* Subject must be on a stable dose of L-dopa, either short-acting or sustained release (in combination with Benserazide or Carbidopa), of at least 200 mg/day administered in at least 2 intakes, for at least 21 days prior to starting Parkinson's diaries
* Subject must be able to differentiate between the "on" and "off" state (and thereby be able to recognize the Time To "On" (TTON)), and be willing and able to accurately complete a Parkinson's Disease subject diary on designated days (with assistance from caregivers, if required)
* Subject must complete 6 Parkinson's diaries over a period of 6 days, with 4 of the 6 Parkinson's diaries being "valid" as determined by the investigator. The "valid" Parkinson's diaries confirm that the subject has an average of at least 2.5 h/day spent in the "off" state
* Subject receiving a Monoamine Oxidase (MAO)-B Inhibitor (eg, Selegiline or Rasagiline), an n-Methyl-d-Aspartate Antagonist (eg, Amantadine), or allowed anti-Parkinson medications and has been on a stable dose for at least 21 days prior to starting Parkinson's diaries and is anticipated to be maintained on that dose for the duration of the study
* Subject has clinical symptoms of Gastrointestinal Dysfunction (GID) confirmed by at least 1 of the following
•Parkinson's disease-related GI symptoms as per the Gastrointestinal Degenerative Scale (GIND) Scale: defecatory dysfunction, constipation, excessive gas, abdominal pain, bloating, nausea, vomiting, anorexia, early satiety, or weight loss (except sialorrhea and dysphagia)
* Female subjects of childbearing potential must agree to use 1 of the following contraceptive methods: oral contraceptive, intrauterine device, or double-barrier method, throughout the study and for 2 weeks after the removal of study medication
Exclusion Criteria
* Subject has participated in another study of an investigational medicinal product (IMP) or a medical device within the last 30 days or is currently participating in another study of an IMP or a medical device
* Subject has an Atypical Parkinsonian Syndrome due to drugs (eg, Metoclopramide, Flunarizine), Metabolic Neurogenetic Disorders (eg, Wilson's Disease), Encephalitis, Cerebrovascular Disease, or Degenerative Disease (eg, Progressive Supranuclear Palsy)
* Subject has a history of Pallidotomy, Thalamotomy, Deep Brain Stimulation, or Fetal Tissue Transplant
* Subject has Dementia, Active Psychosis, or Hallucinations
* Subject exhibits Dopaminergic Dysregulation Syndrome
* Subject is receiving therapy with certain medications in a specific timeframe as specified in the protocol
* Subject has history of chronic Gastrointestinal (GI) Disease not related to Parkinson's disease which in the judgement of the investigator may affect the ability of the subject to participate in the study (ie, Irritable Bowel Syndrome, Diverticulitis, Crohn's Disease, etc) or GI/abdominal surgery (except for Appendectomy, Hysterectomy, or Cholecystectomy)
* Subject has had any GI surgery in the 3 months prior to the Screening Visit
* Subject has a current diagnosis of Epilepsy, has a history of seizures as an adult, or has a history of stroke or Transient Ischemic Attack within 1 year prior to the Screening Visit
* Subject has clinically relevant Hepatic or Renal Dysfunction
* Subject has clinically relevant Cardiac Dysfunction (any cardiac disorder that in the opinion of the investigator would put the subject at risk of clinically relevant arrhythmia)
* Subject has had a Myocardial Infarction within the last 1 year prior to the Screening Visit
* Subject has a history of Symptomatic (not Asymptomatic) Orthostatic Hypotension
* Subject has a Systolic Blood Pressure (BP) \< 105 mmHg at the Screening Visit
* Subject has a history of chronic alcohol or drug abuse within the prior 6 months
* Female subject is pregnant or lactating
* Subject (male or female) is of child bearing potential but not surgically sterile or not using adequate birth control methods
* Subject has evidence of an Impulse Control Disorder according to the Modified Minnesota Impulsive Disorders Interview (mMIDI) at the Screening Visit
* Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the Screening Visit
* Subject has a significant skin disease/condition that would make transdermal drug use inappropriate, including a history of skin sensitivity to adhesives or other transdermal medications
* Subject has a known hypersensitivity to any components of the Rotigotine patch, including Sodium Metabisulfite
* Subject has any medical, psychiatric, or cognitive condition, or laboratory abnormality that would, in the opinion of the investigator, jeopardize or compromise the subject's well-being or ability to participate in the study
30 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
877-822-9493
Locations
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011
Birmingham, Alabama, United States
001
Gilbert, Arizona, United States
022
Fountain Valley, California, United States
017
Irvine, California, United States
028
Pasadena, California, United States
015
Sunnyvale, California, United States
008
Gainesville, Florida, United States
009
Miami, Florida, United States
010
Ormond Beach, Florida, United States
006
Sunrise, Florida, United States
032
Annapolis, Maryland, United States
027
Lincoln, Nebraska, United States
016
Commack, New York, United States
026
Mineola, New York, United States
034
Charlotte, North Carolina, United States
002
Raleigh, North Carolina, United States
007
Salisbury, North Carolina, United States
021
Toledo, Ohio, United States
023
Tulsa, Oklahoma, United States
031
Cordova, Tennessee, United States
018
Memphis, Tennessee, United States
014
Houston, Texas, United States
030
Richmond, Virginia, United States
003
Virginia Beach, Virginia, United States
012
Kirkland, Washington, United States
013
Milwaukee, Wisconsin, United States
Countries
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Related Links
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FDA safety Alerts and Recalls
Other Identifiers
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SP1055
Identifier Type: -
Identifier Source: org_study_id
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