Restless Legs Syndrome
Conditions
Keywords
Idiopathic Restless Leg syndrome
Brief summary
Subjects who meet the diagnosis of idiopathic restless legs syndrome (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 (SPM 936) 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. The 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).
Interventions
DRUGRotigotine
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Idiopathic restless legs syndrome
Exclusion criteria
* History of sleep disturbances
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IRLS sum score and CGI Item 1 score severity of illness | From Baseline at the end of the Maintenance Period |
Secondary
| Measure | Time frame |
|---|---|
| IRLS Responder: A responder is a subject with a decrease of ≥50% in IRLS sum score | From Baseline at the end of the Maintenance Period |
| CGI Item 1 Responder: A responder is defined as a subject with a decrease of ≥50% in CGI Item 1 | From Baseline at the end of the Maintenance Period |
| Changes in CGI Items 2-3 (continuous) during the Maintenance Period; Change from Baseline in RLS-6 Rating Scales at the end of the Maintenance Period | — |
Countries
United States
Outcome results
None listed