EICHORCondition: Amyotrophic Lateral Sclerosis · Sponsor: Mario Negri Institute for Pharmacological Research
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Phase II/III multicenter, randomized, double-blind, placebo-controlled trial on acetyl-L-carnitine (ALCAR) in subjects living with amyotrophic lateral sclerosis (ALS). Primary study aim: The clinical objective consists of assessing the efficacy of ALCAR (two different dosages will be tested: 1.5g/day and 3g/day) on the progression of functional disability (loss of self-sufficiency), as measured by the ALSFRS-R scale. Secondary study aims: 1. The effect of ALCAR treatment on different clinical aspects: functional decline as measured by ALSFRS-R total score; the decline of forced vital capacity (FVC); quality of life as measured by ALSAQ-40 scale; cognitive function as measured by Edinburgh Cognitive and Behavioural ALS Screen (ECAS) scale; survival (being alive and without tracheostomy). 2. To measure the effects of ALCAR treatment on disease biomarkers potentially involved in the drug's mechanisms of action. These include PGC-1 alpha, 3-nitrotyrosine (3-NT), acetyl cyclophilin A (acetyl-PPIA), neurofilament light chain (NFL), creatine kinase (CK), Musclin/osteocrin, MyomiRNA (MiR-206), Uric acid, Matrix metalloproteinase-9 (MMP-9), Monocyte Chemoattractant Protein-1 (MCP-1), 4-Hydroxynonenal (HNE). 3. The tolerability and safety of ALCAR treatment by identifying unexpected adverse events. Study population: 246 subjects will be enrolled on one Australian and ten Italian ALS sites. Inclusion criteria: subjects aged 18+ years with a diagnosis of ALS according to Gold Coast Cri…
This description comes directly from the study's public registry record.
Elisabetta Pupillo, PharmD · 00390239014605 · elisabetta.pupillo@marionegri.it
Always discuss trial participation with your own doctor first.
| Concord Hospital | Sydney, Australia | Recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Dipartimento di Neurologia | Bergamo, Italy | Recruiting |
| Fondazione Serena ONLUS Centro Clinico NEMO Brescia | Brescia, Italy | Recruiting |
| Istituto Auxologico Italiano, IRCCS Dipartimento di Neurologia | Milan, Italy | Recruiting |
| Fondazione Serena ONLUS centro clinico NEMO | Milan, Italy | Recruiting |
| AOU di Modena Nuovo Ospedale Civile S. Agostino Estense di Modena - Ospedale di Baggiovara | Modena, Italy | Recruiting |
| Azienda Ospedaliera Universitaria Federico II Di Napoli | Naples, Italy | Recruiting |
| Azienda Ospedaliera Universitaria "Luigi Vanvitelli", Dipartimento di Scienze mediche e chirurgiche avanzate | Naples, Italy | Not Yet Recruiting |
| Azienda Ospedaliero-Universitaria Maggiore della Carità | Novara, Italy | Recruiting |
| Azienda Ospedale-Università di Padova, Unità di Neurologia Clinica | Padova, Italy | Recruiting |
| A.S.P. Palermo, Villa delle Ginestre Hospital | Palermo, Italy | Not Yet Recruiting |
| Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS | Pavia, Italy | Recruiting |
+ 7 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06126315