Methylphenidate modified release as treatment of MS-associated fatigue

INTERVENTION: Trade Name: Ritalin LA 20mg capsules Product Name: Methylphenidate modified release 20 mg Pharmaceutical Form: Capsule, hard INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE CAS Number: 298‐59‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Ritalin LA 30mg capsules Product Name: Methylphenidate modified release 30 mg Pharmaceutical Form: Capsule, hard INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE CAS Number: 298‐59‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30‐ Trade Name: Ritalin LA 40mg capsules Product Name: Methylphenidate modified release 40 mg Pharmaceutical Form: Capsule, hard INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE CAS Number: 298‐59‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40‐ CONDITION: Fatigue is a very common symptom in multiple sclerosis. Its management comprises nonpharmacologic approaches like exercise, cooling procedures and energy conservation programs and as second step pharmacologic therapy. Until now, Amantadine, Modafinil or antidepressants have been used off‐label among others, with some success. Until now, methylphenidate has been successfully used to treat fatigue in HIV and parkinson´s disease, data on its efficacy in MS are not available. Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: The goal of our study is to determine the efficacy of methylphenidate in reducing fatigue in subjects with Multiple sclerosis. The question of whether MS‐associated fatigue improves after 6 weeks of methylphenidate therapy compared to baseline as measeured by Fatigue severity scale comprises the primary objective of our study.; Primary end point(s): Improvement (baseline vs. 6 weeks) of fatigue as assessed by Fatigue Severity Scale Secondary Objective: Secondary objectives are to evaluate the efficacy of methylphenidate on fatigue in subjects with MS as measured by MFIS (modified fatigue impact scale) and VAS (visual analogue scale), on quality of life as measured by HAQUAMS (Hamburger Lebensqualitätsfragebogen) and on quality of sleep as measured by Epworth Sleepiness Scale and Pittsburgh Sleep Quality Index. An objetive assessment of fatigue will be done by neuropsychological TAP (test for attentional performance ‐subscale alertness and divided attention). Timepoint(s) of evaluation of this end point: Baseline and after six weeks of treatment with study medication SECONDARY OUTCOME: Secondary end point(s): Improvement of fatigue (baseline vs. 6 weeks) as assessed by modified; fatigue impact scale.; Improvement of fatigue (baseline vs. 6 weeks) as assessed by visual; analogue scale.; Improvement of quality of life (baseline vs. 6 weeks) as assessed by; Hamburger Lebensqualitätsfragebogen.; Improvement of fatigue as measured (baseline vs. 6 weeks) by; neuropsycholgical TAP‐testing.; Improvement of sleep quality (baseline vs. 6 weeks) as measured by; ESS and PSQI Timepoint(s) of evaluation of this end point: Baseline and after six weeks of treatment with study medication INCLUSION CRITERIA: Diagnosis of multiple sclerosis (relapsing remitting, progressive courses) according to McDonalds criteria. • Age > 18years • Fatigue as measured by Fatigue Severity Scale • Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36