LATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINE

• 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
• 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

Countries of recruitment

Italy

Contacts

• Name: Elisabetta Pupillo
• Affiliation: Istituto di Ricerche Farmacologiche “Mario Negri” di Milano

• Name: Elisabetta Pupillo
• 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

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

Parkinson disease

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)

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 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

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.