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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 18 January 2016
Main ID:  EUCTR2013-000827-15-IT
Date of registration: 15/03/2013
Prospective Registration: Yes
Primary sponsor: Unità Malattie Neurodegenerative, Ospedale Cardinale Giovanni Panico, Tricase
Public title: LATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINE
Scientific title: LATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINE - PARROT
Date of first enrolment: 11/05/2013
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000827-15
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Italy
Contacts
Name: Elisabetta Pupillo   
Address:  Via La masa 19 20156 Milano Italy
Telephone:
Email: elisabetta.pupillo@marionegri.it
Affiliation:  Istituto di Ricerche Farmacologiche “Mario Negri” di Milano
Name: Elisabetta Pupillo   
Address:  Via La masa 19 20156 Milano Italy
Telephone:
Email: elisabetta.pupillo@marionegri.it
Affiliation:  Istituto di Ricerche Farmacologiche “Mario Negri” di Milano
Key inclusion & exclusion 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:
-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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Parkinson disease
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

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: Transdermal use

Primary Outcome(s)
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
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.
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 Outcome(s)
Timepoint(s) of evaluation of this end point: baseline, V4 and v6
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
Secondary ID(s)
PARROT
Source(s) of Monetary Support
UCB PHARMA S.A.
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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