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

CompletedPhase 1, Phase 2

Sponsor: Hiroshi Mitsumoto

Conditions: Amyotrophic Lateral Sclerosis, Muscle Cramp

Interventions: TJ-68, Placebo

Countries: United States

The primary objective of the study is to demonstrate the safety and potential efficacy of TJ-68 for improving muscle cramps in participants with ALS based on a two-site, randomized, placebo-controlled double-blind multi-period crossover (N-of-1) study design.

Eligibility overview

Sex: ALL

Age: 20 Years to 84 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 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 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
* Unstable or active medical or neurological (other than ALS) diseases which require treatment
* Failure of 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, MCS
* Taking any experimental medication or unapproved medications directed at treating muscle cramps
* Those who are pregnant or breast feeding
* Those who have renal or hepatic impairment

Locations (3)

Scottsdale, Arizona, United States
Jacksonville, Florida, United States
New York, New York, United States