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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00275236

Enrollment

Registered

2006-01-11

Start date

2005-11-30

Completion date

2006-07-31

Last updated

2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless Legs Syndrome

Keywords

Idiopthic Restless Legs Syndrome

Brief summary

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.

Interventions

DRUGRotigotine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Inclusion criteria

* Idiopathic RLS

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Efficacy is assessed by reduction of Periodic Limb Movement Index, which will be obtained from polysomnographic measurements.	—

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026