Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis
Part of paid clinical trials in La Jolla, California.
- Sponsor
- Zydus Therapeutics Inc.
- Study ID
- NCT07023835
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Amyotrophic Lateral Sclerosis (ALS)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 50 mg Usnoflast — DRUG50 mg Usnoflast (50 mg Usnoflast capsules and matching placebo of 25 mg capsule)
- 75 mg Usnoflast — DRUG75 mg Usnoflast (25 mg + 50 mg Usnoflast capsules)
- Placebo — DRUGMatching placebo of 25 mg and 50 mg
Study Details
Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis
Key Dates
- First listed
- Jun 17, 2025
- Start date
- Sep 17, 2025
- Status verified
- Jun 2026
- Primary completion
- Mar 31, 2028
- Completion
- Oct 31, 2028
Study Design
- Enrollment
- 240 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: 50 mg Usnoflast50 mg Usnoflast capsules and matching placebo of 25 mg capsule under fasting conditions twice a day orally for 36 weeks
- Active Comparator: 75 mg Usnoflast25 mg + 50 mg Usnoflast capsules under fasting conditions twice a day orally for 36 weeks
- Placebo Comparator: PlaceboMatching placebo of 25 mg and 50 mg under fasting conditions twice a day orally for 36 weeks
Primary Outcome Measure
Efficacy of Usnoflast versus placebo assessed using the revised ALSFRS-R total score [ Time Frame: From baseline through Week 36 ]
Central Contacts
- Farheen Shaikh6094534751
Locations (15)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Zydus US015 | La Jolla | California | 92037 | Rosemarie Previte |
| Zydus US008 | Orange | California | 92868 | Jeein Kim |
| Zydus US013 | San Francisco | California | 94109 | Valentina Mikhalenko |
| Zydus US005 | New Britain | Connecticut | 06053 | Honora C Dalamagas |
| Zydus US012 | Tampa | Florida | 80045 | Jamie Reddish |
| Zydus US007 | Atlanta | Georgia | 30322 | Jane Bordeau |
| Zydus US010 | Boston | Massachusetts | 02114 | Dario Glevski |
| Zydus US006 | Detroit | Michigan | 48202 | Kelly Tundo |
| Zydus US014 | Lincoln | Nebraska | 68510 | Veronica Botti Gary Pattee (PRINCIPAL_INVESTIGATOR) |
| Zydus US003 | Winston-Salem | North Carolina | 27157 | Mozdeh Mirandi |
| Zydus US009 | Pittsburgh | Pennsylvania | 15212 | Megan Hendricks |
| Zydus US001 | Dallas | Texas | 75206 | Reham Azab |
| Zydus US002 | Houston | Texas | 77030 | Kimberly Esparaza |
| Zydus US004 | Richmond | Virginia | 23298 | Adriana Clegg |
| Zydus US011 | Seattle | Washington | 98122 | Kelly Robertson |
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