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

Late Onset Parkinson's Disease in Subjects 70 Years and Older: Possible Use of Rotigotine

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.

Study Overview

• Status: Terminated
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Placebo; Drug: Rotigotine

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) .

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
  • Brindisi, Italy, 72100
    • Ospedale "A. Perrino"
  • Foggia, Italy, 71100
    • A.O. Universitaria "Ospedali Riuniti" - U.O. Neurologia Ospedaliera
  • Foggia, Italy, 71100
    • A.O. Universitaria "Ospedali Riuniti"-U.O. Neurologia Universitaria
  • Lecce, Italy, 73100
    • Presidio Ospedaliero "Vito Fazzi"
  • Andria-Barletta-Trani
    • Andria, Andria-Barletta-Trani, Italy, 76123
      • Ospedale Lorenzo Bonomo Andria
  • Bari
    • Acquaviva Delle Fonti, Bari, Italy, 70021
      • Ospedale Generale Regionale "F. Miulli"
    • Monopoli, Bari, Italy, 70043
      • Ospedale S. Giacomo
  • Foggia
    • San Giovanni Rotondo, Foggia, Italy, 71013
      • IRCCS "Casa Sollievo della Sofferenza"
  • Lecce
    • Casarano, Lecce, Italy, 73042
      • Ospedale Francesco Ferrari
    • Tricase, Lecce, Italy, 73039
      • A.O. Ospedale "Card. G. Panico" di Tricase

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rotigotine; 80 patients with late onset PD are randomized in 2 parallel groups, ratio 1:1.	Drug: Rotigotine; transdermal patch; Other Names: Neupro
Placebo Comparator: Placebo; 80 patients with late onset PD are randomized in 2 parallel groups, ratio 1:1.	Drug: Placebo; transdermal patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	M2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	M2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responders to treatment in mood in relation to Geriatric Depression Scale (GDS) 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	M2

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Cardinale G. Panico
• Investigators: Study Chair: Giancarlo Logroscino, Prof, A.O. Ospedale "Card G. Panico" di Tricase

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: March 26, 2014
• First Submitted That Met QC Criteria: April 1, 2014
• First Posted (Estimate): April 4, 2014

Study Record Updates

• Last Update Posted (Estimate): January 25, 2016
• Last Update Submitted That Met QC Criteria: January 22, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: treatment; Parkinson's Disease; Rotigotine; old patients
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agonists; Dopamine Agents; Rotigotine
• Other Study ID Numbers: EudraCT Number: 2013-000827-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO