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Therapeutics |
Key Words: restless legs syndrome excitatory amino acid antagonists acetic acids
| The first 150 words of the full text of this article appear below. |
Design
13 week randomised (allocation concealed*), blinded (clinicians and patients),* placebo controlled, crossover trial.
Setting
Madrid, Spain.
Patients
24 patients who were 3375 years of age (mean age 55 y, 67% women) and were diagnosed with idiopathic RLS (established by the International RLS Study Group). Patients with ferritin concentrations <20 µg/ml were excluded. 21 patients (88%) completed the study.
Intervention
Patients were allocated to sequence 1 (gabapentin followed by placebo) or sequence 2 (placebo followed by gabapentin). Gabapentin was given at an initial dose of 600 mg/day, up to a maximum dose of 2400 mg/day. The sequences lasted 6 weeks with a 1 week washout period, and then patients crossed over to the alternate sequence.
Main outcome measures
Difference between groups for change from baseline to week 6 on the RLS Rating Scale (RLS symptom severity classified as mild [015 points], moderate [1625 points], or severe [2640 points]). Secondary outcome measures included patient global impression of
Alberto Albanese, MD, Graziella Filippini, MD
Istituto Nazionale Neurologico Carlo Besta
Milan, Italy
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