Treatment Combining Riluzole and IFB-088 in Bulbar Amyotrophic Lateral Sclerosis (TRIALS Protocol)
Status:
Not yet recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
Prospective, international, randomised, double-blind, placebo controlled, multicentre,
parallel group study. Patients will be randomised in a 2:1 allocation ratio to receive either
IFB-088 + riluzole 100 mg or placebo + riluzole 100 mg. This clinical trial is an exploratory
study, designed to show a signal of efficacy of IFB-088 through ALSFRS-R, MITOS and King's
College. Respiratory function will be followed through SVC. Biomarkers and quality of life
will also be evaluated throughout the study.
Patients will be treated over a 6-month period. After a screening/consent visit, patients
will undergo clinic visits at randomisation (V0), at 2 weeks (V1), and at months 1 (V2), 3
(V3) and 6 (V4). One week after V0, the patient will undergo urine analysis (dipstick) and
blood sampling for measurement of creatinine. At the V2 visit, in addition to other
assessments, patients will undergo blood sampling for PK measurements and urine sampling for
crystalluria examination. Blood and urine chemistry, as well as physical examination and
vital signs assessment to assess safety will be performed at each visit for safety purpose
and crystalluria examination will be repeated at the follow-up visit, performed one month ±
one week after V4.