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

Prior treatment

• Taking any experimental medication or unapproved medications directed at treating muscle cramps

Other illness

• History of allergic reactions to peony root, Glycyrrhiza, or FD\&C Yellow No. 5 (tartrazine)
• Unstable or active medical or neurological (other than ALS) diseases which require treatment
• Failure of Capacity Assessment
• Those who have renal or hepatic impairment

Lab values

• Takes any medication known to increase the risk of pseudoaldosteronism or hypokalemia, including corticosteroids and diuretics (except potassium sparing diuretics, such as spironolactone or amiloride)
• History of pseudoaldosteronism or hypokalemia or current use of potassium supplementation
• Screening potassium level 3.4 mEq/L or less
• Screening albumin below normal laboratory level either at the Columbia or Mayo Clinic laboratory
• Screening bicarbonate or carbon dioxide level less than 29 mmol/L, suggesting metabolic alkalosis
• Screening sodium level greater than 145 mmol/L, suggesting hypernatremia

Other

• Screening diastolic blood pressure (DBP) more than 90 mmHg or systolic blood pressure (SBP) more than 150 mmHg after sufficient rest
• Not able and/or willing to comprehend and sign the informed consent
• Not able to speak or write English to complete the primary outcome measure, MCS
• Those who are pregnant or breast feeding

• 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 medications is allowed).
• Willing to practice contraceptive measures for male and female patients.