Interventional {{label}}

Study to Evaluate Safety & Efficacy of FLX-787-ODT to Treat Fasciculations in Tongue and Appendicular Muscle in Adult Subjects With ALS

Overview

Intervention or Drug Name

Sponsor

Trial Status

Phase

Randomization

Trial Duration

Route of Administration

Genetic Target

Repurposed Drugs

Approved by FDA

Approved outside USA

Is a supplement

Details

Enrollment Criteria

Time since symptom onset

Vital Capacity (FVC or SVC)

Approved Medications

Registry Listing

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Purpose

The FLX-787-107 study will determine how well FLX-787-ODT works to reduce fasciculations in patients with Amyotrophic Lateral Sclerosis (ALS). The study will measure how often fasciculations occur, if tongue and muscle strength, speech, and swallowing are affected, and monitor any side effects that might develop while taking the investigational product. Participants will be assessed before and after taking a single dose of FLX-787-ODT. Approximately 15 people will take part in this study at one center in the United States. Participants will be in the study for a single clinic visit and receive a telephone call 7 days later to monitor for side effects.

What participation looks like

Eligibility criteria

18 Years and older, all genders, not accepting healthy volunteers

Locations

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