XXXX in treatment of @entity1295 in @entity15 . Results of an open-label study.

@entity1 @entity1295 @entity3777 @entity2724 @entity2728 @entity1296 @entity15 @entity25
BACKGROUND: @entity2728 is a unique wake-promoting agent that is chemically distinct from traditional stimulants. Results of a placebo-controlled study showed it to improve @entity1295 in @entity15 ( @entity15 ) at a dose of 200 mg daily, but not at a dose of 400 mg daily. OBJECTIVE: To establish the efficacy, safety and appropriate dose of @entity2728 in the treatment of @entity25 in @entity1 with @entity15 . METHOD: A total of 50 @entity1 diagnosed with @entity15 (mean age 40.4 +/- 10.3 years, 30 females/20 males; @entity15 type: 36 relapsing remitting, 1 primary progressive, 13 secondary progressive; mean disability level 3.8 +/- 1.5 on the Kurtzke EDSS) and complaining of chronic @entity1295 were enrolled in a prospective 3-month, two-center, open-label study. Efficacy was evaluated with the @entity3777 ( @entity3777 , score range 0-42), the Epworth Sleepiness Scale (ESS, score range 0-24) and by subjective @entity1 appraisal of change of @entity1295 , quality of life and overall satisfaction with treatment. Adverse effects (AEs) were recorded throughout the study. Treatment was started with a single daily dose of 100 mg in all @entity1 . In non-responders the dose was increased by 100 mg increments up to a maximum daily dose of 400 mg. RESULTS: Three @entity1 discontinued @entity2728 because of AEs (nervousness, @entity1296 ). Two @entity1 (4 %) were treated with 50 mg, 25 (50 %) with 100 mg, 21 (42 %) with 200 mg and 2 (4 %) with 300 mg daily. No @entity1 required 400 mg daily. Mean @entity3777 scores were 30.3 +/- 8.5 at baseline and 25.4 +/- 3.7 at 3 months (p < 0.0001). Mean ESS scores were 9.7 +/- 3.9 at baseline and 4.9 +/- 2.9 at 3 months (p < 0.0001). Self-appraisal of change of @entity1295 showed clear improvement in 41 @entity1 (87.2 %), some improvement in 4 (8.5 %) and no change in 2 (4.3 %). Overall clinical condition was clearly improved in 43 @entity1 (91.5 %), somewhat improved in 1 @entity1 (2.1 %), and unchanged in 3 @entity1 (6.4 %). No @entity1 reported worsening of overall clinical condition. CONCLUSIONS: Treatment with @entity2728 significantly improves @entity25 and is well tolerated by @entity1 with @entity15 . Unlike the higher dose regimen required in @entity2724 , a low-dose regimen of @entity2728 is effective in @entity15 .
