Grants and Contracts Details
Description
This clinical trial will involve a Study Regimen for the study drug ABBV-CLS-7262 hypothesized to be
important in the pathophysiology of amyotrophic lateral sclerosis (ALS) and other neurodegenerative
conditions when activated chronically (Costa-Mattioli et al. 2020).
Study Objectives
Primary Efficacy Objective -- To evaluate the efficacy of ABBV-CLS-7262 on ALS disease progression.
Secondary Efficacy Objective -- To evaluate the effects of ABBV-CLS-7262 on selected secondary
measures of ALS disease progression, including survival.
Safety Objectives -- To evaluate the safety of ABBV-CLS-7262 in patients with ALS.
Pharmacokinetics Objective -- To quantify the steady state concentrations of A-1684909 and/or any
active or inactive metabolites in plasma after long-term oral dosing of ABBV-CLS-7262 once daily (QD).
Exploratory Objectives -- To evaluate the effects of ABBV-CLS-7262 on selected biomarkers and
exploratory endpoints.
Status | Active |
---|---|
Effective start/end date | 3/8/23 → 3/7/25 |
Funding
- Massachusetts General Hospital: $81,512.00
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