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

Sponsor

Azienda Ospedaliera Cardinale G. Panico (Other)

Overall Status

Terminated

CT.gov ID

NCT02103465

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

7.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: Rotigotine Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

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

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

Outcome Measures

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 [M2]
(*) 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 [M2]
(*) 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

Other Outcome Measures

Responders to treatment in mood in relation to Geriatric Depression Scale (GDS) at visit 4 and 6 [M2]
(*) 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Lorenzo Bonomo Andria	Andria	Andria-Barletta-Trani	Italy	76123
2	Ospedale Generale Regionale "F. Miulli"	Acquaviva Delle Fonti	Bari	Italy	70021
3	Ospedale S. Giacomo	Monopoli	Bari	Italy	70043
4	IRCCS "Casa Sollievo della Sofferenza"	San Giovanni Rotondo	Foggia	Italy	71013
5	Ospedale Francesco Ferrari	Casarano	Lecce	Italy	73042
6	A.O. Ospedale "Card. G. Panico" di Tricase	Tricase	Lecce	Italy	73039
7	Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari	Bari		Italy	70124
8	Ospedale "A. Perrino"	Brindisi		Italy	72100
9	A.O. Universitaria "Ospedali Riuniti" - U.O. Neurologia Ospedaliera	Foggia		Italy	71100
10	A.O. Universitaria "Ospedali Riuniti"-U.O. Neurologia Universitaria	Foggia		Italy	71100
11	Presidio Ospedaliero "Vito Fazzi"	Lecce		Italy	73100