A Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

NCT ID: NCT00275236

Last Updated: 2014-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-07-31

Brief Summary

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The objective of this trial is to demonstrate that rotigotine (SPM 936) is effective in subjects with idiopathic RLS based on the PLMI (Periodic Limb Movements Index)(PLMs/total time in bed) as measured by polysomnography (PSG). The primary variable is the reduction of PLMI at the end of the Maintenance Period compared to Baseline. PLMI data will be obtained from PSGs.

Detailed Description

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Conditions

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Restless Legs Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Rotigotine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Idiopathic RLS

Exclusion Criteria

* secondary RLS
* history of sleep disturbances
* symptomatic orthostatic hypotension
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

Locations

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Schwarz BioSciences

Monheim, , Germany

Site Status

Countries

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Germany

References

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Oertel WH, Benes H, Garcia-Borreguero D, Hogl B, Poewe W, Montagna P, Ferini-Strambi L, Sixel-Doring F, Trenkwalder C, Partinen M, Saletu B, Polo O, Fichtner A, Schollmayer E, Kohnen R, Cassel W, Penzel T, Stiasny-Kolster K. Rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome: a randomized, placebo-controlled polysomnographic study. Sleep Med. 2010 Oct;11(9):848-56. doi: 10.1016/j.sleep.2010.02.014. Epub 2010 Sep 1.

Reference Type RESULT
PMID: 20813583 (View on PubMed)

Other Identifiers

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2005-002814-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SP0794

Identifier Type: -

Identifier Source: org_study_id

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