Universita di Verona — Biomedical Watch V2

Traitements4programmes

Essais2liés

Publications4liées

SourceDBlocale

Traitements

4

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Fear of Falling in Muscular DystrophyPrimary objectives WP1: Evaluate the prevalence of FOF in the study population and how this varies over time. Evaluate whether there are relationships between the variables investigated (clinical, motor, cognitive, psychological) and the presence of FOF. WP2: To evaluate, among those who presented disabling FOF, the effects of two different therapeutic approaches: motor rehabilitation vs. motor rehabilitation plus cognitive-behavioral psychotherapy. Secondary objectives WP1: To evaluate whether different profiles defined by specific clinical, motor, cognitive, psychological, and personological characteristics can be characterized among patients with dystrophy and FOF and how these impact functionality, activity, participation, and quality of life. WP2: Evaluate the effects of cognitive-behavioral therapy (CBT) and a motor treatment on cognitive and psychological aspects, the frequency of falls, and the functional validity.	Myopathies	NA	À vérifier	Italy	À vérifier
SafinamideThis is a Phase III, single-center, randomized, double-blind, placebo-controlled clinical trial designed to investigate the superiority of safinamide compared to a placebo in reducing Parkinson's Disease (PD)-related pain. The trial plans to enroll 60 adult patients diagnosed with PD who experience motor fluctuations and chronic pain (lasting more than 3 months) despite receiving stable doses of levodopa. Participants will be randomized in a 1:1 ratio to receive either oral safinamide or a matching placebo as an add-on therapy. The treatment regimen consists of 50 mg/day for the first week, increasing to 100 mg/day for the remaining 11 weeks, for a total treatment duration of 12 weeks. The primary endpoint is to evaluate the mean change in pain severity from baseline to 12 weeks, measured using the 11-point Numeric Rating Scale (NRS) Secondary endpoints will assess additional qualitative and quantitative pain characteristics (KPPS, BPI, PD-PCS), motor symptoms and treatment complications (UPDRS Parts III and IV, Home Diary), quality of life (PDQ-39), and other non-motor symptoms (MDS-NMS). The total expected duration of the clinical trial is 24 months.	Parkinson	Phase 3	Traitement symptomatique	Italy	À vérifier
Fear of Falling in Muscular DystrophyPrimary objectives WP1: Evaluate the prevalence of FOF in the study population and how this varies over time. Evaluate whether there are relationships between the variables investigated (clinical, motor, cognitive, psychological) and the presence of FOF. WP2: To evaluate, among those who presented disabling FOF, the effects of two different therapeutic approaches: motor rehabilitation vs. motor rehabilitation plus cognitive-behavioral psychotherapy. Secondary objectives WP1: To evaluate whether different profiles defined by specific clinical, motor, cognitive, psychological, and personological characteristics can be characterized among patients with dystrophy and FOF and how these impact functionality, activity, participation, and quality of life. WP2: Evaluate the effects of cognitive-behavioral therapy (CBT) and a motor treatment on cognitive and psychological aspects, the frequency of falls, and the functional validity.	Myopathies	NA	À vérifier	Italy	À vérifier
SafinamideThis is a Phase III, single-center, randomized, double-blind, placebo-controlled clinical trial designed to investigate the superiority of safinamide compared to a placebo in reducing Parkinson's Disease (PD)-related pain. The trial plans to enroll 60 adult patients diagnosed with PD who experience motor fluctuations and chronic pain (lasting more than 3 months) despite receiving stable doses of levodopa. Participants will be randomized in a 1:1 ratio to receive either oral safinamide or a matching placebo as an add-on therapy. The treatment regimen consists of 50 mg/day for the first week, increasing to 100 mg/day for the remaining 11 weeks, for a total treatment duration of 12 weeks. The primary endpoint is to evaluate the mean change in pain severity from baseline to 12 weeks, measured using the 11-point Numeric Rating Scale (NRS) Secondary endpoints will assess additional qualitative and quantitative pain characteristics (KPPS, BPI, PD-PCS), motor symptoms and treatment complications (UPDRS Parts III and IV, Home Diary), quality of life (PDQ-39), and other non-motor symptoms (MDS-NMS). The total expected duration of the clinical trial is 24 months.	Parkinson	Phase 3	Traitement symptomatique	Italy	À vérifier

Essais cliniques

2

Molécule	Indication / population	Phase	NCT	Titre	Statut
Safinamide	Parkinson	Phase 3	NCT07761936	SAVE PAIN — Safinamide vs Placebo for Pain in Patients With Parkinson's Disease and Motor Fluctuations	RECRUITING
Fear of Falling in Muscular Dystrophy	Myopathies	NA	NCT07129954	Fear of Falling in Muscular Dystrophy	RECRUITING

Publications

4

Molécule	Indication / population	Titre	Journal	Date
Fear of Falling in Muscular Dystrophy		The Impact of "Fear of Falling" on Physical Performance, Balance, and Ambulation in Duchenne Muscular Dystrophy.	Neuropediatrics
Safinamide		Add-on safinamide and amantadine in Filipino Parkinson's disease patients with motor fluctuations: a retrospective exploratory cohort study.	Journal of neural transmission (Vienna, Austria : 1996)
Fear of Falling in Muscular Dystrophy		Investigation of the relationship between dual-task performance and functionality and psychosocial features in children with Duchenne Muscular Dystrophy: A controlled study.	Research in developmental disabilities
Fear of Falling in Muscular Dystrophy		Tests of dynamic balance, motor function and fear of falling as indicators of fall risk in children with Duchenne muscular dystrophy.	European journal of paediatric neurology : EJPN : official journal of the European Paediatric Neurology Society