Patient- and physician-rated measures demonstrate the effectiveness of ropinirole in the treatment of restless legs syndrome.
OBJECTIVE
To investigate the effect of twice-daily ropinirole in patients with early evening restless legs syndrome (RLS) symptoms, particularly focusing on the relationship of patient- and physician-rated assessment of treatment outcomes.


METHODS
In this multicenter, double-blind, randomized, 12-week, flexible-dose study, patients with primary RLS, with symptom onset no earlier than 5 PM and a baseline International Restless Legs Syndrome Study Group Rating Scale (IRLS) total score > or = 20 received ropinirole 0.5 to 6.0 mg/d twice daily in equally divided doses, or placebo. First dose was 1 hour before the usual onset of symptoms; second dose was 3 to 8 hours after the first. Primary end point: change from baseline in IRLS total score at week 12 last observation carried forward (LOCF). Key secondary end points: proportion of responders (rated "very much improved" or "much improved") on the Clinical Global Impression-Improvement and the Patient Global Improvement scales.


RESULTS
Improvements in IRLS total score were statistically significantly greater for ropinirole (n = 175), compared with placebo (n = 184) at all assessment points beginning at day 3 through to week 12 LOCF (P < 0.001). A statistically significantly greater proportion of patients were classified as responders on the Clinical Global Impression-Improvement scale at all assessment points from day 3 through week 12 LOCF (P < 0.001) and on the Patient Global Improvement scale at all assessment points from day 1 (P = 0.013) through day 7 LOCF (P < or = 0.05 for days 2-7 LOCF) and at week 12 LOCF (P < 0.001).


CONCLUSIONS
Ropinirole is associated with consistent early and sustained improvements in the symptoms of RLS, as rated by patients and physicians.
Kushida
Clete A
CA
Stanford Center of Excellence for Sleep Disorders, 401 Quarry Road, Suite 3301-A, Stanford, CA 94305-5730, USA. clete@stanford.edu
Geyer
James
J
Tolson
Jerry M
JM
Asgharian
Afsaneh
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010358:Patient Participation / Q000379:methods; D010819:Physician's Role; D012148:Restless Legs Syndrome / Q000188:drug therapy* / Q000503:physiopathology; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
D007211:Indoles; C046649:ropinirole