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

NCT ID: NCT02103465

Last Updated: 2016-01-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-06-30

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) .

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rotigotine

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

Group Type: EXPERIMENTAL

Rotigotine

Intervention Type: DRUG

transdermal patch

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

transdermal patch

Interventions

Rotigotine

transdermal patch

Intervention Type: DRUG

Placebo

transdermal patch

Intervention Type: DRUG

Other Intervention Names

Neupro

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Cardinale G. Panico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giancarlo Logroscino, Prof

Role: STUDY_CHAIR

A.O. Ospedale "Card G. Panico" di Tricase

Locations

Ospedale Lorenzo Bonomo Andria

Andria, Andria-Barletta-Trani, Italy

Ospedale Generale Regionale "F. Miulli"

Acquaviva delle Fonti, Bari, Italy

Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari

Bari, Bari, Italy

Ospedale S. Giacomo

Monopoli, Bari, Italy

Ospedale "A. Perrino"

Brindisi, Brindisi, Italy

A.O. Universitaria "Ospedali Riuniti" - U.O. Neurologia Ospedaliera

Foggia, Foggia, Italy

A.O. Universitaria "Ospedali Riuniti"-U.O. Neurologia Universitaria

Foggia, Foggia, Italy

IRCCS "Casa Sollievo della Sofferenza"

San Giovanni Rotondo, Foggia, Italy

Ospedale Francesco Ferrari

Casarano, Lecce, Italy

Presidio Ospedaliero "Vito Fazzi"

Lecce, Lecce, Italy

A.O. Ospedale "Card. G. Panico" di Tricase

Tricase, Lecce, Italy

Countries

Italy

Other Identifiers

EudraCT Number: 2013-000827-15

Identifier Type: -

Identifier Source: org_study_id