At a glance
ClinicalIndex Comparison Record- ✓Probable or definite ALS per revised El Escorial criteria with bulbar onset
- ✓Symptom onset ≤18 months prior to screening
- ✓Age ≥18 years
- ✓SVC (slow vital capacity) >60% of predicted
- ✕Other significant neurological diseases
- ✕Unstable serious illness (cardiac disease, cancer, hematologic disease, hepatitis, liver or renal failure)
- ✕eGFR <60 mL/min/1.73m²
- ✕Abnormal liver function: total bilirubin >1.5×ULN or AST/ALT >3×ULN
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Placebo-controlled, Exploratory Randomised Clinical Trial to Assess the Safety and Efficacy of IFB-088 Plus Riluzole 100 mg vs Placebo Plus Riluzole 100 mg in Patients With Bulbar-onset Amyotrophic Lateral Sclerosis.
In Brief
A Phase 2 clinical trial evaluating IFB-088 50mg/day, Placebo, and 1 other intervention for Amyotrophic Lateral Sclerosis and ALS. Completed, enrolled 51 participants across 9 sites in 2 countries.
Detailed 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 , as well as blood sampling for measurement of creatinine and calculation of eGFR at months 2, 4 and 5. 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.
Study Details
Timeline
Interventions
Tested product
Placebo
Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo