Phase 2, randomized, double-blind, placebo-controlled trial
Topic / Pathology
- SLA
- Phase 2
Objectives
Primary objective : to evaluate the safety of IFB-088 50 mg/day in patients with bulbar ALS.
Secondary objectives :
1. To evaluate the efficacy of IFB-088 50 mg/day plus riluzole 100 mg/day versus placebo plus riluzole 100 mg/day over a 6-month period in patients with bulbar-onset ALS
2. To determine the pharmacokinetic (PK) parameters of IFB-088
3. To investigate the effects of IFB-088 on potential ALS biomarkers
4. To assess the quality of life (QoL)
Find out more : https://clinicaltrials.gov/ct2/show/NCT05508074
Sponsor
InFlectis BioScience
Investigator
National coordinator : Pr Shahram Attarian
Status
Completed