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

NCT02103465 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-01-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Rotigotine

transdermal patch

DRUG

Placebo

transdermal patch

Sponsors & Collaborators

  • Azienda Ospedaliera Cardinale G. Panico

    lead OTHER

Principal Investigators

  • Giancarlo Logroscino, Prof · A.O. Ospedale "Card G. Panico" di Tricase

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02103465 on ClinicalTrials.gov