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Switching From Oral Dopamine Agonists to Rotigotine

NCT01976871 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2016-11-29

Study results available
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Summary

The primary objective is to demonstrate safety and tolerability of switching patients with Restless Legs Syndrome (RLS) from an oral dopamine agonist to rotigotine.

As a secondary objective, the investigators will evaluate control of RLS symptoms on rotigotine compared to the prior oral regimen.

Conditions

  • Restless Legs Syndrome
  • Ekbom Syndrome
  • Willis-Ekbom Disease

Interventions

DRUG

Rotigotine

Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator.

Sponsors & Collaborators

  • UCB Pharma

    collaborator INDUSTRY

  • John Winkelman, MD, PhD

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-05-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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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 NCT01976871 on ClinicalTrials.gov