Idiopathic Parkinson's Disease MedDRA version: 17.0 Level: LLT Classification code 10013113 Term: Disease Parkinson's System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Mirapexin extended release various strengths
Product Name: Pramipexole dihydrochloride monohydrate extended release
Product Code: N/A
Pharmaceutical Form: Modified-release tablet
INN or Pr
Sponsors
University Hospital of North Staffordshire
Keele University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Demographic characteristics • Males and females. • Aged between 50-80 years. Medical condition • Idiopathic, sporadic Parkinson’s disease, diagnosed by as determined by the UK Parkinson’s Disease Society Brain Bank Clinical Diagnostic Criteria (1992). • Parkinson’s disease stages, mild: 1, 2, 2.5; or moderate: 3 and 4, as determined by the modified Hoehn-Yahr (HY) disease severity rating scale. • Capacity to provide fully informed signed consent. Indicated treatments: • Currently medicated with either Pramipexole modified release (Mirapexin® Prolonged Release) 520 micrograms to 3.15mg or Ropinirole modified release (Requip® XL) range 2mg to 12mg. • Maybe receiving adjuvant therapy with l-dopa and / or a monoamine oxidase B inhibitor (such as rasagiline/AZILECT or selegiline/ ELDEPRYL, ZELAPAR). *Note Patients who are not receiving adjuvant therapy will also meet the inclusion criteria. 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 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: All doses of IMP that fall outside of the inclusion criteria Demographic Characteristics: - Patient-participant-participants younger than 50 and over 80 years of age; - English is a second language. Medical, Psychiatric, Developmental Conditions: Renal impairment (creatinine clearance <50ml/min or eGFR less than 50 ml/minute/1.73m2)Severe hepatic impairment (liver function tests: ALT, Total Bilirubin, Albumin Alk phos/ALP; GGT may also be assessed– depending on the Alk level - 3 times upper limit of normal range) 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; Cognitive impairment as assessed with the Mini-Mental State Examination scoring 25 or less; Severe PD, indicated by a score of 5 on the Hoehn and Yahr disease severity rating scale; - Unable to provide informed consent due to cognitive decline; - Co-morbid for another neurological illness (other than PD); - History of learning difficulty including dyslexia; - Physical inability to attend or comply with treatment scheduling, such as upper limb amputations, crippling degenerative arthritis; - Current or planned participation in another drug trial; - Active malignancy; - Family history of PD; -Patient or family history of allergic reaction to either ropinirole or pramipexole - Drug abuse or alcoholism; - Major psychotic phenomenology including hallucinations or lack of awareness of dyskinesias; - Hypotension; - Severe dizziness or fainting on standing; - Impulse control disorders or compulsive behaviours; - Incapacitating dyskinesias on a stable dose of l-dopa; - pre-planned or elective surgeries during the period of involvement in the trial. Contraindicated Medication and Treatments: COMT inhibitors; apomorphine; amantadine; anticholinergics; dopamine antagonists; ciprofloxacin; immediate-release preparations of either pramipexole dihydrochloride monohydrate or ropinirole hydrochloride; deep brain stimulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a feasibility study designed to inform the following process / primary outcomes: • to obtain estimates of memory performance which will inform a power calculation; • to explore with patient-participants and carers barriers to participation which include management of symptoms during washout period. This will be achieved formally using the end of study focus group as well as informally during mid-and end of study clinic visits with clinical members of research team, and during ON/OFF research visits with the PhD student/assessor. ;Secondary Objective: • drop-out rate; • effectiveness of recruitment strategy; • identification of training needs of members of the research team and patient-participant participant panel (PPI); • to obtain estimates of memory performance which will inform a power calculation gathered during ON and OFF research sessions; • establish the likely staffing resources and timetable needed for the subsequent main study; • validate composition of the neuropsychological test battery; • to gather personal reflections of patient-participant participants and public and patient-participant involvement (PPI) members on their respective research experience. • to explore with patient-participants and carers barriers to participation which include o relative timing of ON and OFF sessions in each treatment arm o duration of the ON and OFF research sessions. ;Primary end point(s): This is a feasibility study designed to inform the following process outcomes: - to obtain estimates of memory performance which will inform a power calculation; - management of symptoms during washout period ;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 ContactProf Nicola Edelstyn
Keele University
Outcome results
None listed