NCT00498108

Brief Summary

This is a multicenter, open-label trial to assess safety and tolerability of rotigotine in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year in subjects who previously participated in SP790 (6-month pivotal trial) or SP794 (sleep lab trial). Subjects who successfully completed the Maintenance Period and the Taper Period of SP790 or SP794 are allowed to enroll in this trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
341

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

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

January 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2009

Enrollment Period

1.7 years

First QC Date

July 6, 2007

Last Update Submit

September 24, 2014

Conditions

Idiopathic Restless Legs Syndrome

Keywords

RotigotineRestless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

  • Adverse events, changes in laboratory tests, vital signs, physical and neurological examination, menstrual and sexual function, 12-lead ECGs. Subject's rating of daytime sleepiness, global subject rating of tolerability

Secondary Outcomes (1)

  • Change in the International Restless Legs Scale (IRLS) sum score, in CGI Items 1 and 2-3, in RLS-6 Rating Scales. IRLS Responder

    from Baseline at the end of the Maintenance Period

Interventions

RotigotineDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject completed the Maintenance Period and Taper Period of SP790 or SP794

You may not qualify if:

  • Subject has an ongoing serious adverse event (SAE) from SP790 or SP794 that is assessed to be related to the trial medication by the investigator and/or the sponsor.
  • Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate in this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kassel, 34128, Germany

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental Disorders

Study Officials

  • UCB Clinical Trial Call Center

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 6, 2007

First Posted

July 9, 2007

Study Start

January 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

September 25, 2014

Record last verified: 2009-09

Locations

DE(1)