NCT00367822

Brief Summary

The objective of this trial is to compare an individually optimized dose of the lisuride TTS patch against placebo and against an individually optimized dose of oral ropinirole (active- and placebo-controlled design) in idiopathic and uremic RLS patients with regard to efficacy, safety, and quality of life.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2006

Completed
Last Updated

March 7, 2012

Status Verified

January 1, 2010

First QC Date

August 22, 2006

Last Update Submit

March 6, 2012

Conditions

Restless Legs Syndrome

Keywords

Restless Legs Syndromedopamine agonistlisurideropinirole

Outcome Measures

Primary Outcomes (1)

  • International Restless Legs Severity Scale (IRLS)

Secondary Outcomes (2)

  • RLS-6 scales

  • CGI

Interventions

LisurideDRUG
RopiniroleDRUG
PlaceboDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic or uremic RLS
  • RLS Diagnostic Index (RLS-DI) \> 10
  • Total score in the IRLS Rating Scale ≥ 15 at baseline
  • No previous treatment for RLS or insufficient current therapy

You may not qualify if:

  • Secondary RLS, e.g. due to iron deficiency (exception: uremia)
  • History or presence of sleep disorders other than RLS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IMEREM GmbH

Nuremberg, Germany

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Lisurideropinirole

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental Disorders

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • Heike Benes, MD

    Somnibene GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 22, 2006

First Posted

August 23, 2006

Last Updated

March 7, 2012

Record last verified: 2010-01

Locations

DE(1)