Clinical Trials

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.
• Experience at least one muscle cramp per day.
• Age 20-70 years old.
• Forced vital capacity is 60% 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.
• Understand the informed consent procedure and are able to give (sign) the informed consent.
• Willing to commute to the study site for 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®), or both 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 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 enzyme or 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.

Exclusion Criteria:

• History of allergic reactions to peony root, Glycyrrhiza, or FD&C Yellow No. 5 (tartrazine).
• 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 diastolic blood pressure (DBP) more than 90 mmHg or systolic blood pressure (SBP) more than 150 mmHg after sufficient rest.
• Screening albumin below normal laboratory level either at the Columbia or Mayo Clinic Jacksonville Laboratory.
• Screening bicarbonate or carbon dioxide level less than 19 mmol/L, suggesting metabolic alkalosis.
• Screening sodium level greater than 145 mmol/L, suggesting hypernatremia.
• Unstable or active medical or neurological (other than ALS) diseases which require treatment.
• Failure of the Capacity Assessment.
• 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, the MCS.
• Taking any experimental medication or unapproved medications.
• Pregnant or breastfeeding.
• Have renal or hepatic impairment.