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

Parkinson's Disease Clinical Trial

— PARROT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02103465
• Other study ID #: EudraCT Number: 2013-000827-15
• Status: Terminated
• Phase: Phase 2
• First received: March 26, 2014
• Last updated: January 22, 2016
• Start date: December 2013
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: Azienda Ospedaliera Cardinale G. Panico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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) .

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Rotigotine
transdermal patch
• Placebo
transdermal patch

Locations

Country	Name	City	State
Italy	Ospedale Generale Regionale "F. Miulli"	Acquaviva Delle Fonti	Bari
Italy	Ospedale Lorenzo Bonomo Andria	Andria	Andria-Barletta-Trani
Italy	Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari	Bari
Italy	Ospedale "A. Perrino"	Brindisi
Italy	Ospedale Francesco Ferrari	Casarano	Lecce
Italy	A.O. Universitaria "Ospedali Riuniti" - U.O. Neurologia Ospedaliera	Foggia
Italy	A.O. Universitaria "Ospedali Riuniti"-U.O. Neurologia Universitaria	Foggia
Italy	Presidio Ospedaliero "Vito Fazzi"	Lecce
Italy	Ospedale S. Giacomo	Monopoli	Bari
Italy	IRCCS "Casa Sollievo della Sofferenza"	San Giovanni Rotondo	Foggia
Italy	A.O. Ospedale "Card. G. Panico" di Tricase	Tricase	Lecce

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Cardinale G. Panico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No