Clinical trial NCT02103465: Possible Use of Rotigotine in Subjects 70 Years and Older With Late Onset of Disease
Official title: Late Onset Parkinson's Disease in Subjects 70 Years and Older: Possible Use of Rotigotine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
treatment
old patients
Rotigotine
Lead sponsor: Azienda Ospedaliera Cardinale G. Panico
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 80
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) .

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

Primary outcomes:
measure: 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
timeFrame: M2
Secondary outcomes:
measure: Percentage of Responders to treatment in sleep quality in relation to Parkinson's Disease Sleep Scale-2 (PDSS) at visit 4 and 6
timeFrame: M2
Other outcomes:
measure: Responders to treatment in mood in relation to Geriatric Depression Scale (GDS) at visit 4 and 6
timeFrame: M2
Locations:
city: Andria
country: Italy
facility: Ospedale Lorenzo Bonomo Andria
state: Andria-Barletta-Trani
city: Acquaviva Delle Fonti
country: Italy
facility: Ospedale Generale Regionale "F. Miulli"
state: Bari
city: Monopoli
country: Italy
facility: Ospedale S. Giacomo
state: Bari
city: San Giovanni Rotondo
country: Italy
facility: IRCCS "Casa Sollievo della Sofferenza"
state: Foggia
city: Casarano
country: Italy
facility: Ospedale Francesco Ferrari
state: Lecce
city: Tricase
country: Italy
facility: A.O. Ospedale "Card. G. Panico" di Tricase
state: Lecce
city: Bari
country: Italy
facility: Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
city: Brindisi
country: Italy
facility: Ospedale "A. Perrino"
city: Foggia
country: Italy
facility: A.O. Universitaria "Ospedali Riuniti" - U.O. Neurologia Ospedaliera
city: Foggia
country: Italy
facility: A.O. Universitaria "Ospedali Riuniti"-U.O. Neurologia Universitaria
city: Lecce
country: Italy
facility: Presidio Ospedaliero "Vito Fazzi"
Study officials:
affiliation: A.O. Ospedale "Card G. Panico" di Tricase
name: Giancarlo Logroscino, Prof
role: STUDY_CHAIR
References: