Clinical Trials Logo
  1. Home
  2. Restless Legs Syndrome
  3. NCT00275236
  4. Details
NCT00275236 Clinical Trial

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

Restless Legs Syndrome Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00275236
Other study ID # SP0794
Secondary ID 2005-002814-39
Status Completed
Phase Phase 3
First received January 10, 2006
Last updated September 24, 2014
Start date November 2005
Est. completion date July 2006

Study information
Verified date September 2009
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date July 2006
Est. primary completion date July 2006
Accepts healthy volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Idiopathic RLS

Exclusion Criteria:

- secondary RLS

- history of sleep disturbances

- symptomatic orthostatic hypotension

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Rotigotine

Locations
Country Name City State
Germany Schwarz BioSciences Monheim

Sponsors (1)
Lead Sponsor Collaborator
UCB Pharma

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Oertel WH, Benes H, Garcia-Borreguero D, Högl B, Poewe W, Montagna P, Ferini-Strambi L, Sixel-Döring 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 i — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy is assessed by reduction of Periodic Limb Movement Index, which will be obtained from polysomnographic measurements.
Secondary Changes in Periodic Limb Movement Arousal Index, Sleep efficiency, International RLS sum score, Clinical Global Impression Item 1.
See also
  Status Clinical Trial Phase
Recruiting NCT04786314 - The Effect of Hot and Cold Water Application on Pregnant Women With Restless Leg Syndrome N/A
Completed NCT01455012 - Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome Phase 4
Terminated NCT01192503 - Safety and Efficacy of Rasagiline in Restless Legs Syndrome Phase 2/Phase 3
Completed NCT00721279 - Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome N/A
Completed NCT00530530 - ASP8825 - Study in Patients With Restless Legs Syndrome Phase 2
Completed NCT00375284 - A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS Phase 4
Completed NCT00942253 - Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS) Phase 2
Completed NCT00479531 - Sequential Compression Devices for Treatment of Restless Legs Syndrome Phase 3
Recruiting NCT05581576 - Pitolisant in Refractory Restless Legs Syndrome Phase 4
Active, not recruiting NCT03218969 - Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist Phase 1/Phase 2
Recruiting NCT04144790 - Impact of Iron Supplementation Treatment on Brain Iron Concentrations
Completed NCT05787080 - Massage, Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome(RLS) N/A
Not yet recruiting NCT05529095 - Sublingual Apomorphine in Refractory Restless Legs Syndrome Phase 4
Recruiting NCT05044520 - Clinical Features Associated With Restless Legs Syndrome.
Withdrawn NCT03849001 - Impact of Acute Leg Cycling at Various Intensities on RLS Severity in Persons With MS N/A
Completed NCT03076541 - Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements. N/A
Recruiting NCT04145674 - A Proof of Concept, Phase 2, Double-blind, Randomized Trial With d-Methadone Product Versus Placebo Phase 2
Completed NCT02532608 - Infra-slow Oscillations During Sleep N/A
Completed NCT01528462 - Sleep Disorders Managed and Assessed Rapidly in Transient Ischemic Attack (TIA) and In Early Stroke
Completed NCT00748098 - Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance Phase 3

External Links