@article{3102731,
    title = "A Prospective, Observational, Cohort Study to Assess the Efficacy and Safety of Prolonged-Release Fampridine in Cognition, Fatigue, Depression, and Quality of Life in Multiple Sclerosis Patients: The FAMILY Study",
    author = "Mitsikostas, D.D. and Doskas, T. and Gkatzonis, S. and Fakas, N. and Maltezou, M. and Papadopoulos, D. and Gourgioti, R. and Mitsias, P.",
    journal = "Advances in Therapy",
    year = "2021",
    volume = "38",
    number = "3",
    pages = "1536-1551",
    publisher = "Adis",
    issn = "0741-238X",
    doi = "10.1007/s12325-020-01606-5",
    keywords = "alemtuzumab;  antidepressant agent;  anxiolytic agent;  azathioprine;  beta1a interferon;  beta1b interferon;  cyclophosphamide;  dimethyl fumarate;  fampridine;  fingolimod;  glatiramer;  mitoxantrone;  natalizumab;  teriflunomide, adult;  agitation;  Article;  asthma;  atrial fibrillation;  backache;  Beck Depression Inventory;  clinical assessment;  clinical evaluation;  clinical practice;  cluster headache;  cognition;  cohort analysis;  comparative effectiveness;  constipation;  controlled study;  depression;  dizziness;  drug effect;  drug efficacy;  drug safety;  dyspnea;  fatigue;  Fatigue Impact Scale;  female;  functional status assessment;  Greece;  headache;  human;  hyperhidrosis;  hypertension;  hypesthesia;  insomnia;  major clinical study;  male;  middle aged;  migraine;  Modified Fatigue Impact Scale;  multicenter study;  multiple sclerosis;  Multiple Sclerosis Impact Scale;  Multiple Sclerosis International Quality of Life Questionnaire;  Multiple Sclerosis Walking Scale;  nausea;  observational study;  outpatient care;  paced auditory serial addition test;  positional vertigo;  prescription;  presyncope;  prospective study;  quality of life;  quality of life assessment;  questionnaire;  respiratory tract infection;  restlessness;  sleep disorder;  social psychology;  somnolence;  tachycardia;  upper abdominal pain;  upper respiratory tract infection;  urinary tract infection;  walking speed;  cognition;  depression;  fatigue, Adult;  Cognition;  Cohort Studies;  Depression;  Fatigue;  Greece;  Humans;  Multiple Sclerosis;  Prospective Studies;  Quality of Life",
    abstract = "Introduction: The efficacy of prolonged-release fampridine (PR-FAM) may extend in multiple sclerosis (MS) beyond walking ability. The objective of this study was to evaluate the effect of PR-FAM treatment on cognition, fatigue, depression, and quality of life (QoL) in adult patients with MS in a real-world setting. Methods: FAMILY was a multi-center, prospective, observational, real-world cohort study of MS patients receiving PR-FAM in the outpatient setting. Patients were treated as per PR-FAM’s local prescribing information for 6 months. Standardized protocols and questionnaires were used to evaluate changes in cognition (PASAT; Paced Auditory Serial Addition Test), fatigue (MFIS; Modified Fatigue Impact Scale), depression (BDI-II; Beck Depression Inventory-II) and QoL (MusiQoL; MS International Quality-of-Life questionnaire, MSIS-29; Multiple Sclerosis Impact Scale: PHYS and PSYCH subscales) at 3 and 6 months compared to baseline. Results: In total, 102 eligible patients from 8 sites in Greece were analysed, of whom 92 completed the study and 10 discontinued. At 6 months, PR-FAM treatment resulted in improvements from baseline in PASAT-3′′ (p = 0.044), MFIS (p < 0.001), BDI-II (p < 0.001), MusiQoL (p < 0.001) and MSIS-29-PHYS (p = 0.012) and MSIS-PSYCH (p < 0.001). A positive effect was evident already at 3 months in PASAT-3′′ (ns), MFIS (p = 0.020), BDI-II (p = 0.034), MusiQoL (p = 0.001), MSIS-29-PHYS (ns) and MSIS-29-PSYCH (p < 0.001). Conclusions: This observational study provides new data to the current literature in support of PR-FAM’s positive effects in cognition, fatigue, depression, and QoL in a large, heterogeneous group of Greek MS patients in the real-world setting. Trial Registration: ClinicalTrials.gov identifier, NCT03164018. © 2021, The Author(s)."
}