Parkinson disease
Conditions
Interventions
Trade Name: Rotigotine
Product Name: neurpro
Product Code: SPM962
Pharmaceutical Form: Transdermal patch
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo: T
Sponsors
Unità Malattie Neurodegenerative, Ospedale Cardinale Giovanni Panico, Tricase
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age =70 years -Idiopathic PD confirmed by at least two of the following signs: resting tremor, bradikynesia, rigidity -Diagnosis of 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
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, DA or other PD medication at baseline -Centrally acting dopaminergic agents, 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 DSM-IV-R -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective Primary objective: To assess efficacy and safety of rotigotine in patients with late onset PD, starting at age 70 or later, on motor symptoms. ;Secondary Objective: Secondary objectives Secondary objective: To assess efficacy and safety of rotigotine in patients with late onset PD, starting at age 70 or later, on selected non motor symptoms : • sleep quality • depression • cognitive function ;Primary end point(s): Comparison of the two treatment groups in the percentage of responders at 4 months. Responders is the improvement of at least 20% in the sum of scores UPDRS part 2 and 3;Timepoint(s) of evaluation of this end point: 16 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Comparison between the two treatment groups in the percentage of responders to visit 4 and 6 in scores of stairs PDSS-2 and GDS;Timepoint(s) of evaluation of this end point: baseline, V4 and v6 | — |
Countries
Italy
Contacts
Public ContactElisabetta Pupillo
Istituto di Ricerche Farmacologiche “Mario Negri” di Milano
Outcome results
None listed