0000000000796041

AUTHOR

Il Simone

showing 3 related works from this author

Randomized double-blind placebo-controlled trial of acetyl-L-carnitine for ALS.

2013

Our objective was to assess the effects of acetyl-L-carnitine (ALC) with riluzole on disability and mortality of amyotrophic lateral sclerosis (ALS). Definite/probable ALS patients, 40-70 years of age, duration 6-24 months, self-sufficient (i.e. able to swallow, cut food/handle utensils, and walk), and with forced vital capacity (FVC) > 80% entered a pilot double-blind, placebo-controlled, parallel group trial and were followed for 48 weeks. ALC or placebo 3 g/day was added to riluzole 100 mg/day. Primary endpoint: number of patients no longer self-sufficient. Secondary endpoints: changes in ALSFRS-R, MRC, FVC and McGill Quality of Life (QoL) scores. Analysis was made in the intention-to-tr…

Maleamyotrophic lateral sclerosisVital CapacityPlacebo-controlled studyPilot ProjectsGastroenterologylaw.inventionRandomized controlled triallawAcetyl-L-carnitineamyotrophic lateral sclerosis; motor neuron disease; randomized trial; acetyl-l-carnitinerandomized trialAmyotrophic lateral sclerosisAcetylcarnitineALS acetyl-L-carnitineNootropic AgentsRiluzoleMiddle AgedRiluzoleTreatment OutcomeNeurologyCombinationDisease Progressionmotor neuron diseaseDrug Therapy CombinationSettore MED/26 - NeurologiaFemaleAcetylcarnitinemedicine.drugAdultmedicine.medical_specialtyAcetyl-L-carnitine amyotrophic lateral sclerosis motor neuron disease randomized trialDouble blindDouble-Blind MethodDrug TherapyInternal medicinemedicineHumansAgedMED/26 - NEUROLOGIAbusiness.industryDisease progressionmedicine.diseaseAcetyl-L-carnitineSurgeryQuality of LifeAcetylcarnitine; Adult; Aged; Amyotrophic Lateral Sclerosis; Disease Progression; Double-Blind Method; Drug Therapy Combination; Excitatory Amino Acid Antagonists; Female; Humans; Male; Middle Aged; Nootropic Agents; Pilot Projects; Quality of Life; Riluzole; Treatment Outcome; Vital CapacityNeurology (clinical)businessExcitatory Amino Acid Antagonists
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Post-marketing of disease modifying drugs in multiple sclerosis: an exploratory analysis of gender effect in interferon beta treatment.

2009

Background: There are a few and conflicting results from randomised controlled trials (RCTs) pertaining to the influence of gender in response to currently used disease modifying drugs in Multiple Sclerosis (MS). Observational studies may be especially valuable for answering effectiveness questions in subgroups not studied in RCTs. Objective: To conduct a post-marketing analysis aimed to evaluate the gender effect on Interferon beta (IFN beta) treatment response in a cohort of relapsing (RR) MS patients. Methods: A cohort of 2570 IFN beta-treated RRMS was prospectively followed for Lip to 7 years in 15 Italian MS Centers. Cox proportional hazards regression models were used to assess gender…

AdultMalemedicine.medical_specialtyMultiple SclerosisPropensity scoreDiseasegender; interferon beta; multiple sclerosis; observational study; propensity scoreLower riskSeverity of Illness IndexMultiple sclerosis Interferon beta Gender Observational study Propensity scoreCohort StudiesDisability EvaluationYoung AdultSex Factorsgender multiple sclerosis treatment interferonDouble-Blind MethodInternal medicineObservational studymedicinegenderConfidence IntervalsOdds RatioProduct Surveillance PostmarketingHumansImmunologic FactorsMultiple sclerosiProportional Hazards ModelsExpanded Disability Status ScaleProportional hazards modelbusiness.industryMultiple sclerosisDrug Administration RoutesInterferon-betamedicine.diseaseInterferon betaSurgeryNeurologyItalyCohortPropensity score matchingRegression AnalysisSettore MED/26 - NeurologiaObservational studyFemaleNeurology (clinical)business
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Erythropoietin in amyotrophic lateral sclerosis: a multicentre, randomized, double blind, placebo controlled, phase III study.

2015

Objective To assess the efficacy of recombinant human erythropoietin (rhEPO) in amyotrophic lateral sclerosis (ALS). Methods Patients with probable laboratory-supported, probable or definite ALS were enrolled by 25 Italian centres and randomly assigned (1:1) to receive intravenous rhEPO 40 000 IU or placebo fortnightly as add-on treatment to riluzole 100 mg daily for 12 months. The primary composite outcome was survival, tracheotomy or >23 h non-invasive ventilation (NIV). Secondary outcomes were ALSFRS-R, slow vital capacity (sVC) and quality of life (ALSAQ-40) decline. Tolerability was evaluated analysing adverse events (AEs) causing withdrawal. The randomisation sequence was computer-…

MaleGastroenterologylaw.inventionRandomized controlled triallaw1506Amyotrophic lateral sclerosisMOTOR NEURON DISEASEeducation.field_of_studyRecombinant ProteinMiddle AgedRecombinant ProteinsTreatment OutcomePsychiatry and Mental HealthNeuromuscularSettore MED/26 - NeurologiaFemaleerythropoietyn clinical trialmedicine.drugHumanALS; MOTOR NEURON DISEASE; Adult; Aged; Amyotrophic Lateral Sclerosis; Double-Blind Method; Erythropoietin; Female; Humans; Male; Middle Aged; Recombinant Proteins; Treatment OutcomeAdultmedicine.medical_specialtyPopulationSocio-culturalePlaceboDouble blindALS; erythropoietyn clinical trialDouble-Blind MethodArts and Humanities (miscellaneous)ALS; MOTOR NEURON DISEASE; Adult; Aged; Amyotrophic Lateral Sclerosis; Double-Blind Method; Epoetin Alfa; Erythropoietin; Female; Humans; Male; Middle Aged; Recombinant Proteins; Treatment Outcome; Neurology (clinical); Psychiatry and Mental Health; Surgery; Arts and Humanities (miscellaneous)Internal medicinemedicineALS; MOTOR NEURON DISEASEHumanseducationErythropoietinAgedbusiness.industryAmyotrophic Lateral SclerosisEpoetin alfamedicine.diseaseSurgeryClinical trialEpoetin AlfaErythropoietinSurgeryNeurology (clinical)ALSbusinessAmyotrophic Lateral Sclerosi
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