NCT01498120

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2011

Typical duration for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 23, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
10 months until next milestone

Results Posted

Study results publicly available

September 21, 2016

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

4 years

First QC Date

December 16, 2011

Results QC Date

August 1, 2016

Last Update Submit

July 6, 2017

Conditions

Restless Legs Syndrome

Keywords

RotigotineRestless Legs SyndromeRLSLong-termAdolescents

Outcome Measures

Primary Outcomes (2)

  • Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study

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

    Visit 1 (Day 1) through End of Study (approximately 2 years)

  • Number of Subjects With At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study

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

    From Visit 1 (Day 1) through End of Study (approximately 2 years)

Study Arms (1)

Rotigotine

EXPERIMENTAL

Optimal dose after titration period 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)

Drug: Rotigotine

Interventions

RotigotineDRUG

Optimal dose after titration period 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) 1 patch /day

Rotigotine

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Tolerated the first dose level of Rotigotine in a previous study in adolescents with Restless Legs Syndrome (RLS), without meeting withdrawal criteria
  • Is expected to benefit from participation, in the opinion of the investigator
  • Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule, and study patch application/removal, according to the judgment of the investigator

You may not qualify if:

  • Previously participated in this study
  • Is experiencing an ongoing serious adverse event (SAE) that is assessed to be related to Rotigotine by the investigator or sponsor
  • Pregnant or nursing or is a female of childbearing potential who is not surgically sterile or does not consistently use 2 combined medically acceptable methods of birth control (including at least 1 barrier method), unless not sexually active
  • Any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate
  • Active suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since the Last Visit" version of the Columbia Suicide Severity Rating Scale (C-SSRS) of the final evaluation visit of the previous Rotigotine study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

012

Los Angeles, California, United States

Location

009

Orange, California, United States

Location

014

Spring Hill, Florida, United States

Location

013

Indianapolis, Indiana, United States

Location

001

Destrehan, Louisiana, United States

Location

Related Links

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental Disorders

Results Point of Contact

Title
Clinical Trial Registries and Results Disclosure
Organization
UCB BIOSCIENCES GmbH
clinicaltrials@ucb.com
40789+49 2173 48

Study Officials

  • UCB Clinical Trial Call Center

    1-877-822-9493 (UCB)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2011

First Posted

December 23, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 1, 2017

Results First Posted

September 21, 2016

Record last verified: 2017-07

Locations

US(5)