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

Azienda Ospedaliera Cardinale G. Panico

Status and phase

Terminated

Phase 2

Conditions

Parkinson's Disease

Treatments

Drug: Rotigotine

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02103465

EudraCT Number: 2013-000827-15

Details and patient eligibility

About

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.

Full 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) .

Enrollment

80 patients

Sex

All

Ages

70+ years old

Volunteers

No 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