Following completion of the ALS Early Feasibility Study of the MyoRegulator® device for treatment of ALS (NCT06165172), the CALM study will further assess the feasibility of the MyoRegulator® device to treat ALS in an expanded number of individuals with ALS. CALM will gather additional preliminary evidence of clinical safety and potential effectiveness in this patient population with a longer follow-up period and additional secondary endpoints in a single-arm study prior to commencing a larger sham-controlled pivotal trial.
18-80 years of age inclusive
Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS as defined by revised El Escorial criteria
Less than or equal to 3 years since ALS symptom onset
Slow Vital Capacity ≥ 50% of predicted capacity at the time of Screening as determined using a portable spirometer
Study participants who are on permanent assisted ventilation (PAV) defined as >22h of noninvasive or invasive ventilation a day for > 7 consecutive days.
Study participants who have been diagnosed with ALS having only clinical bulbar involvement
Implanted intrathecal pump
Prior botulinum toxin injection(s) at any site within 12 weeks of study enrollment
PathMaker Neurosystems Inc.
Lead sponsor
Beth Israel Deaconess Medical Center
Collaborator
United States Department of Defense
Collaborator