Idiopathic Parkinson's Disease
Conditions
Interventions
Product Name: rotigotine
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: 92206-54-7
Concentration unit: Other
Concentration type: up to
Concentration number: -16 mg/
Sponsors
Research and Development University Hospital of North Staffordshire
Keele University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - A diagnosis of idiopathic, sporadic Parkinson's (UK-Brain Bank Criteria). - A Hoehn and Yahr (1967) severity staging of 1-4. - An established prescription of rotigotine with/without controlled release l-dopa therapy, and with/without a monoamine oxidase-B inhibitor. or - An established prescription of controlled release l-dopa therapy, with/without adjuvant monoamine Oxidase-B inhibitor (absence of a dopamine agonist). - Aged between 50-80 years. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 21 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria
Exclusion criteria: - Significant cognitive decline indicated by a score of less than 26 on the Mini- Mental State Examination (MMSE, Foltstein et al, 1975) or by a functional assessment by a clinician during a screening visit. - Younger than 50 or older than 80. - A history of hallucinations. - Other psychiatric or neurological illness (other than Parkinson's). - Doses of medication that are above maximum recommended dose. - Women of child bearing potential unless they are using a recognised effective form of contraception or are not sexually active and have no intention of becoming sexually active during the course of the trial. - Familial Parkinson's Disease. - Unable to provide informed consent due to cognitive decline. - Learning difficulties. - History of alcohol or drug abuse. - Physical inability to attend or comply with the trial schedule. - Severe Parkinson's as indicated by a score 5 on the Hoehn and Yahr Disease rating scale. - English not first language (the recognition memory test uses words that have been standardised within the English language). - Active malignancy. - COMT inhibitors, apomorphine, amantadine and anticholinergic therapy. These treatment have been previously shown to impair cognitive performance (such as memory).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is not a hypothesis testing trial, but an acceptability and feasibility trial to provide data for a power calculation which will inform a larger, multi-centered, fully powered investigation. The data for this power calculation will be estimates of recollection, generated from the test of recognition memory(hit rate minus false alarm rate). This data will be reported using descriptive statistics.;Secondary Objective: - To assess management of Parkinson's symptoms during the washout period in preparation for the OFF-medication session. - To explore barriers to participation. - To validate the composition of neuropsychological test battery. - Identification of training needs and staffing resources required for a fully powered investigation ;Primary end point(s): The primary outcome measure is ON- and OFF-medication recollection performance estimates. These estimates will then be used in a power calculation to inform a fully powered study.;Timepoint(s) of evaluation of this end point: End of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
United Kingdom
Contacts
Public ContactProfessor Nicola Edelstyn
Keele University
Outcome results
None listed