NCT02103465

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

March 26, 2014

Last Update Submit

January 22, 2016

Conditions

Parkinson's Disease

Keywords

Parkinson's Diseasetreatmentold patientsRotigotine

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Percentage of Responders to treatment in sleep quality in relation to Parkinson's Disease Sleep Scale-2 (PDSS) at visit 4 and 6

    M2

Other Outcomes (1)

  • Responders to treatment in mood in relation to Geriatric Depression Scale (GDS) at visit 4 and 6

    M2

Study Arms (2)

Rotigotine

EXPERIMENTAL

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

Drug: Rotigotine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

RotigotineDRUG

transdermal patch

Also known as: Neupro
Rotigotine
PlaceboDRUG

transdermal patch

Placebo

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Ospedale Lorenzo Bonomo Andria

Andria, Andria-Barletta-Trani, 76123, Italy

Location

Ospedale Generale Regionale "F. Miulli"

Acquaviva delle Fonti, Bari, 70021, Italy

Location

Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari

Bari, Bari, 70124, Italy

Location

Ospedale S. Giacomo

Monopoli, Bari, 70043, Italy

Location

Ospedale "A. Perrino"

Brindisi, Brindisi, 72100, Italy

Location

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

Foggia, Foggia, 71100, Italy

Location

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

Foggia, Foggia, 71100, Italy

Location

IRCCS "Casa Sollievo della Sofferenza"

San Giovanni Rotondo, Foggia, 71013, Italy

Location

Ospedale Francesco Ferrari

Casarano, Lecce, 73042, Italy

Location

Presidio Ospedaliero "Vito Fazzi"

Lecce, Lecce, 73100, Italy

Location

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

Tricase, Lecce, 73039, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Giancarlo Logroscino, Prof

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2014

First Posted

April 4, 2014

Study Start

December 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

January 25, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(11)