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NCT01498120 · ClinicalTrials.gov registry record · Phase 2

Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome

A Phase 2 study, sponsored by UCB Biosciences.

Completed
Registry status
Phase 2
Development phase
14
Enrollment target

NCT01498120: Completed Phase 2 study, sponsored by UCB Biosciences.

NCT01498120 is a Phase 2 study that has completed, run by UCB Biosciences. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01498120, a Phase 2 study, has completed, sponsored by UCB Biosciences.

COMPLETED
Registry status
Phase 2
Development phase
14 participants
Enrollment target

Study Summary

This is a Phase 2, multicenter, open-label, single-arm, optimal dose, long-term follow-up study of monotherapy administration of rotigotine transdermal patch in adolescents with Restless Legs Syndrome (RLS). This study will assess the long-term safety and tolerability of Rotigotine treatment in adolescents with RLS.

Primary Outcome

An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Interventions

  • DRUG Rotigotine

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2011-12
Est. Completion 2015-12
Phase Phase 2
UCB Biosciences

39 total trials

What the finished NCT01498120 record still lists

NCT01498120 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 1 intervention - of which Rotigotine is the first listed.

NCT01498120 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01498120 about?

NCT01498120 is a clinical study titled "Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome". This is a Phase 2, multicenter, open-label, single-arm, optimal dose, long-term follow-up study of monotherapy administration of rotigotine transdermal patch in adolescents with Restless Legs Syndrome (RLS). This study will assess the long-term safety and tolerability of Rotigotine treatment in adol...

What is the current status of trial NCT01498120?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2011-12. Estimated completion is 2015-12.

What interventions are being tested in trial NCT01498120?

The interventions under investigation include: Rotigotine (DRUG).

Who is sponsoring clinical trial NCT01498120?

This trial is sponsored by UCB Biosciences, which has 39 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01498120's enrollment target sits among peer trials

14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01498120, the US trial registry maintained by the National Library of Medicine. NCT01498120 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.