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Possible Use of Rotigotine in Subjects 70 Years and Older With Late Onset of Disease (PARROT)

Primary Purpose

Parkinson's Disease

Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Rotigotine
Placebo
Sponsored by
Azienda Ospedaliera Cardinale G. Panico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, treatment, old patients, Rotigotine

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥70 years
  • Idiopathic Parkinson's Disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity
  • Diagnosis of Parkinson's Disease (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

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, Dopamine Agonist (DA) or other Parkinson's Disease (PD) medication at baseline
  • Centrally acting dopaminergic agents, monoamine oxidase inhibitors (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 Diagnostic and Statistic Manual (DSM)-IV-Revised
  • 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

Sites / Locations

  • Ospedale Lorenzo Bonomo Andria
  • Ospedale Generale Regionale "F. Miulli"
  • Ospedale S. Giacomo
  • IRCCS "Casa Sollievo della Sofferenza"
  • Ospedale Francesco Ferrari
  • A.O. Ospedale "Card. G. Panico" di Tricase
  • Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
  • Ospedale "A. Perrino"
  • A.O. Universitaria "Ospedali Riuniti" - U.O. Neurologia Ospedaliera
  • A.O. Universitaria "Ospedali Riuniti"-U.O. Neurologia Universitaria
  • Presidio Ospedaliero "Vito Fazzi"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rotigotine

Placebo

Arm Description

80 patients with late onset PD are randomized in 2 parallel groups, ratio 1:1.

80 patients with late onset PD are randomized in 2 parallel groups, ratio 1:1.

Outcomes

Primary Outcome Measures

Percentage of Responders to treatment (*) in motor (part III) and Activities of daily living (ADL) (part II) components of Unified Parkinson's Disease Rating Scale (UPDRS) at visit 4 and 6
(*) Responder to treatment is a subject who has at least a 20% decrease in the sum of scores (parts II and III) from the Unified Parkinson's Disease Rating Scale (UPDRS) subtotal from baseline to the end of the maintenance phase in the direction of normality. The outcome will be valuate on Month 2 and Month 4

Secondary Outcome Measures

Percentage of Responders to treatment in sleep quality in relation to Parkinson's Disease Sleep Scale-2 (PDSS) at visit 4 and 6
(*) Responder to treatment is a subject who has at least a 20% decrease in the sum of scores (parts II and III) from the Unified Parkinson's Disease Rating Scale (UPDRS) subtotal from baseline to the end of the maintenance phase in the direction of normality The outcome will be valuate on Month 2 and Month 4

Full Information

First Posted
March 26, 2014
Last Updated
January 22, 2016
Sponsor
Azienda Ospedaliera Cardinale G. Panico
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1. Study Identification

Unique Protocol Identification Number
NCT02103465
Brief Title
Possible Use of Rotigotine in Subjects 70 Years and Older With Late Onset of Disease
Acronym
PARROT
Official Title
Late Onset Parkinson's Disease in Subjects 70 Years and Older: Possible Use of Rotigotine
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Because the rate of recruitment was very slow
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Ospedaliera Cardinale G. Panico

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This exploratory trial will fulfill a medical data gap for the dopamine-agonist rotigotine, as so far no data on elderly population is available. Primary objective: To assess efficacy and safety of rotigotine in patients with late onset Parkinson's Disease (PD), starting at age 70 or later, on motor symptoms. Secondary objective: To assess efficacy and safety of rotigotine in patients with late onset Parkinson's Disease (PD), starting at age 70 or later, on selected non motor symptoms : sleep quality; depression; cognitive function. Subjects ≥70 years, with diagnosis of Parkinson's Disease (PD) based on the presence of at least two of three cardinal features (bradykinesia, resting tremor, rigidity), within 12 months since diagnosis and no longer than 12 months from onset to diagnosis, and for whom the caring physician is uncertain on whether or not to start treatment. Outcome Measurement: Percentage of Responders to treatment in motor (part III) and Activities of daily living (ADL) (part II) components of Unified Parkinson's Disease Rating Scale (UPDRS) at visit 4 and 6; Percentage of Responders to treatment in sleep quality in relation to Parkinson's Disease Sleep Scale (PDSS)-2 at visit 4 and 6; Responders to treatment in mood in relation to Geriatric Depression Scale (GDS) at visit 4 and 6. Exploratory, randomized, double blind, placebo-controlled study: 80 patients with late onset Parkinson's Disease (PD) are randomized in 2 parallel groups, ratio 1:1. One group will be treated with rotigotine and one group will be treated with placebo, for 12 weeks after titration.
Detailed Description
Treatment is titrated to optimal dose (that at which investigator and subject felt that motor and non motor impairment are adequately controlled), starting at 2 mg/24 hr and increasing with weekly increments of 2 mg/24 hr up to a maximum of 8 mg/24 hr. The dose is maintained at the optimal or maximal dose for a 8-week period (maintenance period) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease, treatment, old patients, Rotigotine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rotigotine
Arm Type
Experimental
Arm Description
80 patients with late onset PD are randomized in 2 parallel groups, ratio 1:1.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
80 patients with late onset PD are randomized in 2 parallel groups, ratio 1:1.
Intervention Type
Drug
Intervention Name(s)
Rotigotine
Other Intervention Name(s)
Neupro
Intervention Description
transdermal patch
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
transdermal patch
Primary Outcome Measure Information:
Title
Percentage of Responders to treatment (*) in motor (part III) and Activities of daily living (ADL) (part II) components of Unified Parkinson's Disease Rating Scale (UPDRS) at visit 4 and 6
Description
(*) Responder to treatment is a subject who has at least a 20% decrease in the sum of scores (parts II and III) from the Unified Parkinson's Disease Rating Scale (UPDRS) subtotal from baseline to the end of the maintenance phase in the direction of normality. The outcome will be valuate on Month 2 and Month 4
Time Frame
M2
Secondary Outcome Measure Information:
Title
Percentage of Responders to treatment in sleep quality in relation to Parkinson's Disease Sleep Scale-2 (PDSS) at visit 4 and 6
Description
(*) Responder to treatment is a subject who has at least a 20% decrease in the sum of scores (parts II and III) from the Unified Parkinson's Disease Rating Scale (UPDRS) subtotal from baseline to the end of the maintenance phase in the direction of normality The outcome will be valuate on Month 2 and Month 4
Time Frame
M2
Other Pre-specified Outcome Measures:
Title
Responders to treatment in mood in relation to Geriatric Depression Scale (GDS) at visit 4 and 6
Description
(*) Responder to treatment is a subject who has at least a 20% decrease in the sum of scores (parts II and III) from the Unified Parkinson's Disease Rating Scale (UPDRS) subtotal from baseline to the end of the maintenance phase in the direction of normality. The outcome will be valuate on Month 2 and Month 4
Time Frame
M2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥70 years Idiopathic Parkinson's Disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity Diagnosis of Parkinson's Disease (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 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, Dopamine Agonist (DA) or other Parkinson's Disease (PD) medication at baseline Centrally acting dopaminergic agents, monoamine oxidase inhibitors (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 Diagnostic and Statistic Manual (DSM)-IV-Revised 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giancarlo Logroscino, Prof
Organizational Affiliation
A.O. Ospedale "Card G. Panico" di Tricase
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale Lorenzo Bonomo Andria
City
Andria
State/Province
Andria-Barletta-Trani
ZIP/Postal Code
76123
Country
Italy
Facility Name
Ospedale Generale Regionale "F. Miulli"
City
Acquaviva Delle Fonti
State/Province
Bari
ZIP/Postal Code
70021
Country
Italy
Facility Name
Ospedale S. Giacomo
City
Monopoli
State/Province
Bari
ZIP/Postal Code
70043
Country
Italy
Facility Name
IRCCS "Casa Sollievo della Sofferenza"
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Ospedale Francesco Ferrari
City
Casarano
State/Province
Lecce
ZIP/Postal Code
73042
Country
Italy
Facility Name
A.O. Ospedale "Card. G. Panico" di Tricase
City
Tricase
State/Province
Lecce
ZIP/Postal Code
73039
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Ospedale "A. Perrino"
City
Brindisi
ZIP/Postal Code
72100
Country
Italy
Facility Name
A.O. Universitaria "Ospedali Riuniti" - U.O. Neurologia Ospedaliera
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
A.O. Universitaria "Ospedali Riuniti"-U.O. Neurologia Universitaria
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Presidio Ospedaliero "Vito Fazzi"
City
Lecce
ZIP/Postal Code
73100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Possible Use of Rotigotine in Subjects 70 Years and Older With Late Onset of Disease

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