Patients suffering for Idiopathic Parkinson’s Disease. H&Y stage > or = 2 with un-satisfactory control by on-going pharmacological therapy (Levodopa, COMT & MAO-inhibitors), characterised by an incomplete control of motor signs, in particular presence of early morning akinesia, as well as gait deficits in the morning. MedDRA version: 14.1 Level: PT Classification code 10056242 Term: Parkinsonian gait System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: NEUPRO*7CER 4MG/24H
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: rotigotina
CAS Number: 92206-54-7
Concentration unit: mg milligram(s)
Concentration type: up to
Concentratio
Sponsors
FONDAZIONE SANTA LUCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients with idiopathic PD, age range between 50 and 75; 2. Modified Hoehn and Yahr Score either =2 (and therapy only on LD – any formulation, soluble, standard, or prolonged release, i.e.). 3. PD patients willing and able to comply with scheduled visits, treatment plan and other study procedures. They should be able to recognize the off-time and on-time periods during waking hours and fulfill the different self-rated diaries. 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Atypical parkinsonism syndromes due to drugs or neurodegenerative disease. 2. Dementia, a defined by Mini-Mental State Exam score <24 at Screening visit. 3. PD patients already in treatment with oral dopamine agonists in the last 3 months. 4. any significant comorbility and systemic disease that could prevent compliance or completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Evaluation of the efficacy of rotigotine on parkinsonian patients gait performance in the morning time through Gait-Analysis system;Timepoint(s) of evaluation of this end point: Second and fifth week;Main Objective: Determine the efficacy of rotigotine (up to 16mg) on gait parameters as well as mean velocity and stride percentages (swing, stance, double stance) 6 weeks after titration end.;Secondary Objective: Assess the significance of the response to rotigotine in terms of clinical scales by UPDRS, W/O scale, Morning Akinesia scale, GCI and time spent in OFF during the day and quality of life (PDQ39) 6 weeks after titration end. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of the effect of rotigotine on clinical scales (UPDRS, W / O scales, scales Morning akinesia, GCI) and quality of life (PDQ39 scales and a clinical diary daily);Timepoint(s) of evaluation of this end point: first, third, fifth and sixth week | — |
Countries
Italy
Contacts
Public ContactDIREZIONE SCIENTIFICA
FONDAZIONE SANTA LUCIA
Outcome results
None listed