Restless Legs Syndrome
Conditions
Keywords
RLS, PLMS, Adolescent, Periodic Limb Movements of Sleep, Ropinirole
Brief summary
This is a two-period dose rising study of Ropinirole Immediate Release in adolescent patients with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole titration regimen for this age group. Patients will receive two single doses unless poor tolerability is observed following the first dose.
Interventions
Ropinirole Immediate Release
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Adolescent subjects diagnosed with probable or definite Restless Leg Syndrome (RLS).
Exclusion criteria
* Subjects who require RLS treatment during the daytime, suffer from other primary sleep disorders or are taking medication known to induce drowsiness, affect RLS or sleep, or to induce or treat alertness, including methylphenidate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC(0-8), Cmax. Safety (adverse events, vital signs, ECG, laboratory parameters), Change in BP, Incidence of adverse events. Number of periodic limb movements and Number of periodic limb movements per hour (as measured by actigraphy). | Up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| PK - tmax, t1/2, For SKF-89124 and SKF-104557 - ratio of metabolite AUC:ropinirole AUC. PD - Leg movement as measured by actigraphy. | Up to 3 years |
Countries
Belgium, France, United States
Outcome results
None listed