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

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 70 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), 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 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
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 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/6/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Bjorn Oskarsson, M.D.

Open for enrollment

Contact information:

ALS Research Team

(904) 953-6912

mayofloridaALSresearch@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20531309

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