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Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome

NCT01495793 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-04-04

Study results available
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Summary

This was a multicenter, open-label, dose-escalation, Phase 2A study with multiple administrations of the rotigotine transdermal system. The study was conducted in adolescent subjects (13 to \<18 years of age) with idiopathic Restless Legs Syndrome (RLS).

Conditions

  • Restless Legs Syndrome

Interventions

DRUG

Rotigotine

Rotigotine transdermal patch: Dose (size): 0.5 mg/24 h (2.5 cm\^2)- 1 mg/24 h (5 cm\^2)- 2 mg/24 h (10 cm\^2)- 3 mg/24 h (15 cm\^2) The patch has to be applied continuously for 24h. After 24h, the patch has to be removed and a new one applied.

Sponsors & Collaborators

  • UCB BIOSCIENCES, Inc.

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · 1-877-822-9493 (UCB)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-05-31
Completion
2014-05-31

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 NCT01495793 on ClinicalTrials.gov