Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study
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
• For TTNCS: Median CMAP ≥ 1.5 mV
• Willing to forgo botulinum toxin, phenol or alcohol injections, intrathecal baclofen, digitalis, and morphine for the study duration
• Willing to refrain from participation in any other therapeutic clinical trial or investigational product for ALS for the duration of this study
• Women must not be able to become pregnant (e.g., post-menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study and 3 months after study completion.
• Stable dose of rilutek (Riluzole), edaravone (Radicava), or tofersen (Qualsody) and oral medications for muscle spasms/cramps (e.g. mexiletine, quinine, quinidine, magnesium, gabapentin, oxcarbazepine, baclofen) for at least 30 days prior to the onset of participation in the study
⁃ ALS Functional Rating Score (ALSFRS-R) of greater than or equal to 35
⁃ Willing and able to give informed consent