Rotigotine and memory in Parkinson's.

• Register: EUCTR
• Last refreshed on: 4 August 2015
• Main ID: EUCTR2014-000335-17-GB
• Date of registration: 23/07/2014
• Prospective Registration: Yes
• Primary sponsor: Research and Development University Hospital of North Staffordshire
• Public title: Rotigotine and memory in Parkinson's.
• Scientific title: The Effect of Rotigotine on Memory in Idiopathic Parkinson's Disease without Cognitive Impairment - Rotigotine and Memory in Parkinson's.
• Date of first enrolment: 28/10/2014
• Target sample size: 0
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000335-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 3

Countries of recruitment

United Kingdom

Contacts

• Name: Professor Nicola Edelstyn
• Affiliation: Keele University

• Name: Professor Nicola Edelstyn
• Affiliation: Keele University

Key inclusion & exclusion 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:
- 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).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Idiopathic Parkinson's Disease

Intervention(s)

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/24 h

Product Name: levodopa CR (controlled release)
Pharmaceutical Form: Tablet
INN or Proposed INN: levodopa
CAS Number: 59-92-7
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: -1000

Product Name: Rasagiline
Pharmaceutical Form: Tablet
INN or Proposed INN: Rasagiline
CAS Number: 1875-50-9
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: -1 mg/24h

Product Name: Selegiline
Pharmaceutical Form: Tablet
INN or Proposed INN: selegiline
CAS Number: 14611-51-9
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: -12mg/24hs

Primary Outcome(s)

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.

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

Timepoint(s) of evaluation of this end point: End of study.

Secondary Outcome(s)

Secondary end point(s): None

Timepoint(s) of evaluation of this end point: N/A

Secondary ID(s)

MPR001

Source(s) of Monetary Support

National Institute for Health Research

Secondary Sponsor(s)

Keele University