This is a study of Kamlanoflast in patients with ALS. Kamlanoflast is orally administered over 24 weeks. Its effects on inflammatory and functional parameters will be studied. Information on safety and tolerability will be collected.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Low dose Kamlanoflast by oral administration
High dose Kamlanoflast by oral administration
Incidence of Treatment-Emergent Adverse Events [Safety]
Safety: Defined as the occurrence of serious and non-serious treatment-emergent adverse events (TEAEs) and clinically significant treatment-emergent abnormalities in clinical and laboratory values, in ALS subjects treated with study treatment.
Time frame: From drug initiation through study completion, an average of 28 weeks
Incidence of Completing Study Treatment [Tolerability]
Tolerability: Defined as percentage of ALS subjects who complete the 24 weeks of study treatment (survival), without study drug-attributed intolerable AEs that lead to early permanent drug discontinuation.
Time frame: From drug initiation through study completion, an average of 24 weeks
Biological Efficacy
Biological Efficacy: Changes from baseline over 24 weeks (longitudinal assessments) in blood neuroinflammatory marker levels following oral study drug treatment.
Time frame: From enrollment through the end of study treatment at the Week 24 visit (longitudinal assessments)
ALS Functional Rating Scale Revised (ALSFRS-R) total and sub-domain scores
Changes from baseline over 6 month period (longitudinal monthly assessments) in ALS Functional Rating Scale Revised (ALSFRS-R) total and sub-domain scores. The 12 domains included in the ALSFRS-R are rated on a 5-point scale, 0 to 4, with a maximum score of 48 indicating the highest level of functioning.
Time frame: From enrollment to the end of study treatment at the Week 24 Visit (longitudinal assessments)
Slow vital capacity (SVC)
Changes from baseline over 24 weeks in SVC (longitudinal assessments).
Time frame: From enrollment to the end of study treatment at the Week 24 Visit (longitudinal assessments)
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Systemic Exposure
Systemic Exposure: Defined as blood study drug level measurement over 24 weeks of treatment (longitudinal assessments).
Time frame: From enrollment to end of study treatment at the Week 24 Visit (longitudinal assessments)