Trial on the Biological and Clinical Effects of Acetyl-L-carnitine in ALS
In plain words A Phase 2 and 3 study of acetyl-L-carnitine in people 18 and older, run by Mario Negri Institute for Pharmacological Research. It plans to enroll about 246 people at 19 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Amyotrophic Lateral Sclerosis.
- Age 18+;
- ALS diagnosis according to the Gold Coast Criteria;
- Disease duration < 24 months from symptom onset, as indicated by limb weakness or bulbar symptoms, at the randomization/baseline visit*;
- Self-sufficiency \[Satisfactory bulbar and spinal function (score 3+ on the ALSFRS-R for swallowing, cutting food and handling utensils, and walking)\];
7 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Acetyl-l-carnitine; Placebo
Registered summary
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 full summary is on the listing.
Where, as registered
No US site; Italy (18), Australia (1).