CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 enrolled
Drug / intervention
Rotigotinedrug
Likely dose
Rotigotine 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01976871
NCT01976871Phase 4Completed
CompareCT.gov

A Method to Switch From Oral Dopamine Agonists to Rotigotine in Patients With Restless Legs Syndrome

John Winkelman, MD, PhD·interventional·Posted Nov 6, 2013·Updated Nov 29, 2016

In Brief

A Phase 4 clinical trial evaluating Rotigotine for Restless Legs Syndrome and 2 related conditions. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Legs Syndrome, Ekbom Syndrome, Willis-Ekbom Disease
CountriesUnited States
CollaboratorsUCB Pharma

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 6, 2013
Enrollment StartAug 1, 2014
Primary CompletionMay 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.7 years ago

Interventions

Rotigotinedrug

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.