A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Usnoflast Administered to Adult Subjects With ALS
Zydus Therapeutics Inc.
Summary
Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis
Description
A phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter 36 weeks study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of Usnoflast administered to adult subjects with Amyotrophic Lateral Sclerosis followed by 16 weeks open label extension study. This Open Label Extension will be a multicenter, 16-week, single arm study to confirm the long-term safety and efficacy of Usnoflast in subjects with ALS. Eligible subjects of all three arms of the main study will be recruited in the OLE phase and will receive Usnoflast (75 mg) for a total of 16…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of probable or definite Amyotrophic lateral sclerosis, according to the revised version of the El Escorial World Federation of Neurology criteria * Time since onset of first symptom of Amyotrophic lateral sclerosis ≤24 months. Date of Amyotrophic lateral sclerosis symptom onset. For the purposes of this study, the date of symptom onset will be defined as the date the subject first had symptoms of their disease, i.e., limb weakness, dysarthria, dysphagia, shortness of breath, or fasciculations, from the screening visit. * Amyotrophic Lateral Sclerosis Functional…
Interventions
- Drug50 mg Usnoflast
50 mg Usnoflast (50 mg Usnoflast capsules and matching placebo of 25 mg capsule)
- Drug75 mg Usnoflast
75 mg Usnoflast (25 mg + 50 mg Usnoflast capsules)
- DrugPlacebo
Matching placebo of 25 mg and 50 mg
Locations (49)
- Zydus US015La Jolla, California
- Zydus US008Orange, California
- Zydus US013San Francisco, California
- Zydus US005New Britain, Connecticut
- Zydus US012Tampa, Florida
- Zydus US007Atlanta, Georgia