TJ-68 Clinical Trial in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle Cramps

Inclusion Criteria: * Diagnosed with ALS, PMA or PLS based on the El Escorial ALS Diagnostic Criteria or based on more recently revised Gold Coast ALS diagnostic criteria * Experiences at least one muscle cramp in any muscle per day * Age 20 to 84 years old * Forced vital capacity is 45% of normal or greater in a seated position * Able to swallow liquid via the mouth or be given via a feeding tube * Caregiver available to assist with speaking or writing on behalf of the participant if they are not able to speak or write due to the disease * Able to comprehend and willing to give (sign) the informed consent * Willing to commute to the study site for the frequent visits, including a screening visit (study visits at the end of week 2, 5, 8 and 11) * Taking a stable dose of Riluzole (Rilutek), Edaravone (Radicava), and/or sodium phenylbutyrate/taurursodiol (Relyvrio) for at least a month before randomization and not expected to require dose titration or initiation of these medications during the study period * Willing to discontinue over-the-counter (OTC) products containing any peony root, Glycyrrhiza, or both * Willing to discontinue Mexiletine, Quinine sulfate, or Ranolazine during the study period * Willing to avoid food, beverages, and medications that may induce or inhibit metabolism of enzyme of transporters. * Willing to refrain from initiation or dose adjustment of baclofen, gabapentin, pregabalin, and/or memantine during the study period (stable dosing of these medicat…