Male and female adolescent patients, aged 13 to 17 years, diagnosed with RLS based on the IRLSSG consensus criteria (Allen RP 2014) (Appendix 2).
Total RLS severity score of 15 or greater on the IRLS rating scale at Visit 1 (screening) and at Visit 2 (baseline) (Appendix 8).
RLS symptoms for at least 4 of 7 consecutive evenings/nights during the screening period.
Body weight greater than 33.4 kg and a healthy weight using age-based body mass index (BMI) range 5th-85th percentile at screening and baseline. Appendix 3 contains BMI-for-age charts that can be consulted.
Estimated creatinine clearance of at least 60 mL/min (using the Cockcroft-Gault equation) at screening only.
Signed patient and parent Institutional Review Board (IRB)-approved informed consent/assent form (as applicable) before any study-related procedures are performed.

NCT02560766_inc_T1
Person
Male
NCT02560766_inc_T2
Person
female
NCT02560766_inc_T3
Person
adolescent
NCT02560766_inc_T4
Person
aged
NCT02560766_inc_T5
Value
13 to 17 years
NCT02560766_inc_T6
Condition
RLS
NCT02560766_inc_T7
Measurement
IRLSSG consensus criteria
NCT02560766_inc_T8
Measurement
Total RLS severity score
NCT02560766_inc_T9
Value
15 or greater
NCT02560766_inc_T10
Multiplier
at least 4 of 7 consecutive evenings/nights
NCT02560766_inc_T11
Condition
RLS symptoms
NCT02560766_inc_T12
Measurement
Body weight
NCT02560766_inc_T13
Value
greater than 33.4 kg
NCT02560766_inc_T14
Measurement
body mass index
NCT02560766_inc_T15
Measurement
BMI
NCT02560766_inc_T16
Value
5th-85th percentile
NCT02560766_inc_T17
Measurement
Estimated creatinine clearance
NCT02560766_inc_T18
Value
at least 60 mL/min