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Completed

NCT Number: NCT00275236

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

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.

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Key information

Conditions

Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Schwarz BioSciences

Monheim, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Idiopathic RLS

Exclusion criteria

  • secondary RLS
  • history of sleep disturbances
  • symptomatic orthostatic hypotension

Treatment and study plan

Rotigotine

Drug

Primary outcomes

  1. Efficacy is assessed by reduction of Periodic Limb Movement Index, which will be obtained from polysomnographic measurements.

Secondary outcomes

  1. Changes in Periodic Limb Movement Arousal Index, Sleep efficiency, International RLS sum score, Clinical Global Impression Item 1.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Multi-center, Double-blind, Randomized, Placebo-controlled, Two-arm, Parallel-group, Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jan 11, 2006
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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