Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02103465 : Possible Use of Rotigotine in Subjects 70 Years and Older With Late Onset of Disease
PhasePhase 2
AgesMin: 70 Years Max: N/A
Eligibility
Inclusion Criteria:

- Age ?70 years

- Idiopathic Parkinson's Disease (PD) confirmed by at least two of the following signs:
resting tremor, bradykinesia, rigidity

- Diagnosis of Parkinson's Disease (PD) within the last 12 months and onset of symptoms
within 12 months from diagnosis

- Disease stage I or II according to Hoehn and Yahr Scale

- Ability to provide written informed consent

- Patients willing and able to comply with scheduled visits, treatment plan, laboratory
tests and other study procedures

Exclusion Criteria:

- Disease duration more than 12 months since diagnosis and/or duration of symptoms at
diagnosis for more than 12 months

- Hoehn & Yahr stage ?3

- Atypical or secondary parkinsonism

- Patient currently on L-dopa, Dopamine Agonist (DA) or other Parkinson's Disease (PD)
medication at baseline

- Centrally acting dopaminergic agents, monoamine oxidase inhibitors (MAOIs),
tolcapone, budipine, neuroleptics taken within the 28 days preceding the baseline
visit

- History of deep brain stimulation

- History of severe cardiac disease/heart failure in the last 3 years

- History of repeated falls

- History of sulfite sensitivity

- Arterial hypotension

- Stroke or a transient ischemic attack within the last 12 months

- Previous or current treatment with rotigotine (at any time)

- Diagnosis of dementia according to Diagnostic and Statistic Manual (DSM)-IV-Revised

- Mini Mental State Examination (MMSE) total score <24 at screening visit

- History of psychosis

- Clinically relevant hepatic dysfunction and/or transaminase levels 5+ times higher
than upper normal value

- Experimental treatments within the antecedent 3 months

- History of drug or alcohol dependency

- Poor compliance with treatment

- Inability to comply with protocol
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02103465      |      Link to official Clinicaltrials.gov listing
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