Restless Legs Syndrome

Restless Legs

Clinical Trial: A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FIVE-ARM PARALLEL-GROUP TRIAL TO INVESTIGATE THE EFFICACYAND SAFETY OF FOUR DIFFERENT TRANSDERMAL DOSES OF ROTIGOTINE IN SUBJECTS WITH IDIOPATHIC RESTLESS LEGS SYNDROME

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Purpose
Eligibility
Location and Contact Information
More Information

This study is currently recruiting patients.
Verified by Schwarz Pharma August 2005

Sponsored by:	Schwarz Pharma
Information provided by:	Schwarz Pharma
ClinicalTrials.gov Identifier:	NCT00135993

Purpose

Subjects who meet the diagnosis of idiopathic RLS based on the 4 cardinal clinical features according to the International Restless Legs Syndrome Study Group (IRLSSG) are allowed to enroll in this trial.

The primary objective of this trial is to demonstrate that rotigotine is efficacious in subjects with idiopathic Restless Legs Syndrome. Additional objectives are to investigate the safety and tolerability of rotigotine.

Subjects will be randomized to receive either placebo, 1.125, 2.25, 4.5, or 6.75mg/day rotigotine in a 1:1:1:1:1 (active:placebo) fashion. Approximately 600 subjects will be enrolled in this trial, participating at approximately 60 sites. Maximum duration of the trial is approximately 8 months (consisting of a 4-week Titration Period, a 6-month Maintenance Period, a 7-day Taper Period, and a 30-day Safety Follow-Up Period).

Condition	Intervention	Phase
Idiopathic Restless Leg syndrome	Drug: SPM 936	Phase III

MedlinePlus related topics: Restless Legs

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Eligibility

Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

Idiopathic Restless Leg syndrome

Exclusion Criteria:

History of sleep disturbances

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00135993

Margaret Richardson margaret.richardson@schwarzbiosciences.com

North Carolina
Schwarz, RTP, North Carolina, United States; Recruiting

Margaret Richardson

More Information

Study ID Numbers: SP792
Last Updated: August 25, 2005
Record first received: August 24, 2005
ClinicalTrials.gov Identifier: NCT00135993
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30

Source: ClinicalTrials.gov
Cache Date: August 31, 2005

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A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FIVE-ARM PARALLEL-GROUP TRIAL TO INVESTIGATE THE EFFICACYAND SAFETY OF FOUR DIFFERENT TRANSDERMAL DOSES OF ROTIGOTINE IN SUBJECTS WITH IDIOPATHIC RESTLESS LEGS SYNDROME - Article

General Topics A-Z

Restless Legs Syndrome

Restless Legs

Clinical Trial: A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FIVE-ARM PARALLEL-GROUP TRIAL TO INVESTIGATE THE EFFICACYAND SAFETY OF FOUR DIFFERENT TRANSDERMAL DOSES OF ROTIGOTINE IN SUBJECTS WITH IDIOPATHIC RESTLESS LEGS SYNDROME

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Purpose

Eligibility

Location and Contact Information

More Information

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A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FIVE-ARM PARALLEL-GROUP TRIAL TO INVESTIGATE THE EFFICACYAND SAFETY OF FOUR DIFFERENT TRANSDERMAL DOSES OF ROTIGOTINE IN SUBJECTS WITH IDIOPATHIC RESTLESS LEGS SYNDROME - Article

General Topics A-Z

Restless Legs Syndrome

Restless Legs

Clinical Trial: A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FIVE-ARM PARALLEL-GROUP TRIAL TO INVESTIGATE THE EFFICACYAND SAFETY OF FOUR DIFFERENT TRANSDERMAL DOSES OF ROTIGOTINE IN SUBJECTS WITH IDIOPATHIC RESTLESS LEGS SYNDROME

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Purpose

Eligibility

Location and Contact Information

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