A Multicenter, Randomized, Double-blind, Placebo-controlled, 5-arm, Parallel-group Trial to Assess Rotigotine Transdermal System Dose Response in Subjects With Advanced-stage Parkinson´s Disease
- Conditions
- -G20 Parkinson´s diseaseParkinson´s diseaseG20
- Registration Number
- PER-044-10
- Lead Sponsor
- CB BioSciences Inc.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 0
• The subject must receive information and have enough time and opportunity to evaluate their participation in this study, and their informed written consent must be given.
• The subject must be willing and able to meet all the requirements of the study.
• The subject must be> 30 years old.
• The subject must have idiopathic Parkinson´s disease, lasting more than 3 years, as defined by cardinal signs, bradykinesia, plus the presence of at least 1 of the following symptoms: resting tremor, stiffness, problems with postural reflexes and no other known or suspected cause of parkinsonism.
• The investigator must observe the subject in the active (on) and inactive (off) state and determine that he is in stage ü to IV of the Hoehn and Vahr scale both in the active (on) state as inactive (off) -
• The subject must obtain a score> 25 in the Mini Mental State Examination (MMSE).
• The subject should receive a stable dose of levodopa, rapid-acting or prolonged release (in combination with benserazide or carbidopa) of at least 200 mg / day for at least 28 days before onset (visit 2), administered at least 2 you take
• The subject is not correctly controlled with the dose of levodopa (in combination with benserazide or carbidopa) and, at the discretion of the treating physician, said dose is correct.
• The subject must be willing and able to accurately complete a diary of the subject on the established days (with the help of the people who take care of him, if necessary), record the periods in which he is active without problematic dyskinesia , active with problematic dyskinesia, inactive (off) and asleep.
• As part of the pre-treatment evaluations, the subject must watch a training video and complete a diary for a period of 6 days and, at the discretion of the investigator, 4 of the 6 diaries should be considered valid.
• The researcher must be sure that the subject is able to differentiate between the active (on) and inactive (off) status and the valid journals must confirm that the subject has an average of at least 2.5 h / day in the inactive (off) state
• The subject must have been receiving a stable dose of an anticholinergic agent (eg, benztropine, trihexyphenidyl Oj parsitan, procyclidine, biperiden), a monoamine oxidase inhibitor (MAOI) B (eg, selegelin), an antagonist of n-methyl-d-aspartate (NMDA) (e.g., amantadine) for at least 28 days before the start (visit 2) and should be anticipated that that dose will be maintained for the duration of the study.
• The subject must have been receiving a stable dose of all medications against Parkinson´s disease for at least 20 days before the start of the first 6 daily.
• The subject has previously participated in a study with rotigotine or has received rotigotine available in the market.
• The subject is participating in another study of a drug under investigation or has participated in one in the 28 days prior to the initial visit (visit 2).
• The subject has one or more atypical Parkinson´s syndromes caused by drugs (eg, metoclopramide, flunarizine), neurogenetic metabolic disorders (eg, Wilson´s disease), encephalitis, cerebrovascular disease or degenerative disease (eg ., progressive supranuclear paralysis).
• The subject has a history of palidotomy, thalamotomy, deep brain stimulation or fetal tissue transplantation.
• The subject has dementia, active psychosis or hallucinations.
• Currently, the subject is treated with a dopamine agonist or has received it within 28 days prior to the visit 2.
• Currently, the subject receives treatment with the following drugs or has received it within 28 days prior to the initial visit (visit 2): metoclopramide, methylphenidate, amphetamine, tolcapone or neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozaptna, quetiapine).
• Currently, the subject is treated with the following drugs or has received it in the 3 months prior to the initial visit (visit 2): MAO-A inhibitors (pargiline, phenelzine and tranylcypromine), reserpine or alpha-methidopa.
• Currently, the subject receives active treatment (eg, sedatives, hypnotics, antidepressants, anxiolytics) for the central nervous system (CNS), unless the dose remains stable for at least 28 days before the initial visit ( visit 2) and can remain stable for the duration of the study.
• Currently, the subject has been diagnosed with epilepsy, has a history of seizures as an adult and / or has a history of stroke or transient ischemic accident in the year prior to the visit 1.
• The subject has clinically important liver failure.
• The subject has clinically important renal failure.
• The subject has clinically important heart failure (any disorder that, at the discretion of the investigator, could cause the subject to be at risk of suffering a clinically important arrhythmia) or myocardial infarction in the last 12 months.
• The subject has a corrected QT interval for a heart rate interval (QTc)> 500 ms in the visit or has an average QTc interval> 500 ms in the initial visit (visit 2). The average is taken from 3 ECGs that are made at least 15 minutes apart (the Bazett formula must be used for the correction of the QT interval),
• The subject has a history of symptomatic (non-asymptomatic) orthostatic hypotension with a decrease in blood pressure (BP) after passing from the supine position to the standing position of> 20 mmHg in systolic BP, or> 10 mmHg in diastolic BP after 1 or 3 minutes in the 28 days prior to the initial visit (visit 2), or systolic BP of <105 mmHg in the selection (visit 1).
• The subject has a history of significant skin hypersensitivity to adhesives or other transdermal systems or unresolved recent contact dermatitis.
• The subject has a history of chronic alcoholism or chronic drug addiction in the last 5 years.
• The subject is a woman who is pregnant or breastfeeding or has the capacity to become pregnant, but (i) has not been surgically sterilized or (ii) is not using appropriate contraceptive methods (including at least 1 barrier method) or (iii) does not practice sexual abs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method