Main
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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:
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EUCTR |
Last refreshed on:
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18 January 2016 |
Main ID: |
EUCTR2013-000827-15-IT |
Date of registration:
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15/03/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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LATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINE
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Scientific title:
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LATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINE - PARROT |
Date of first enrolment:
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11/05/2013 |
Target sample size:
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Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000827-15 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Name:
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Elisabetta Pupillo
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Address:
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Via La masa 19
20156
Milano
Italy |
Telephone:
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Email:
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elisabetta.pupillo@marionegri.it |
Affiliation:
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Istituto di Ricerche Farmacologiche “Mario Negri” di Milano |
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Name:
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Elisabetta Pupillo
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Address:
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Via La masa 19
20156
Milano
Italy |
Telephone:
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Email:
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elisabetta.pupillo@marionegri.it |
Affiliation:
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Istituto di Ricerche Farmacologiche “Mario Negri” di Milano |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Parkinson disease
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Intervention(s)
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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
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Primary Outcome(s)
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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
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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.
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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
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Timepoint(s) of evaluation of this end point: 16 week
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: baseline, V4 and v6
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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
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Source(s) of Monetary Support
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UCB PHARMA S.A.
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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