← Back to Search

TJ-68 for ALS

Phase 1 & 2

Waitlist Available

Led By Hiroshi Mistumoto, MD, Dsc.

Research Sponsored by Hiroshi Mitsumoto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Forced vital capacity is 45% of normal or greater in a seated position

Willing to discontinue Mexiletine, Quinine sulfate, or Ranolazine during the study period

Must not have

History of pseudoaldosteronism or hypokalemia or current use of potassium supplementation

Failure of Capacity Assessment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 2, week 5, week 8 and week 11

Summary

This trial is testing if a new drug called TJ-68 is safe and effective for improving muscle cramps in people with ALS. The trial is double-blind, meaning that neither the participants nor the researchers will know who is receiving the drug or the placebo.

Who is the study for?

Adults aged 20-70 with ALS, PMA, or PLS who experience daily muscle cramps. They must be able to swallow liquids, have a caregiver if needed for communication, and can travel to the study site. Participants should be on stable doses of certain ALS medications and not taking specific OTC products or drugs that affect enzyme metabolism.

What is being tested?

The trial is testing TJ-68 against a placebo to see if it helps with muscle cramps in ALS patients. It's a double-blind study where neither doctors nor participants know who gets the real treatment as they're randomly assigned.

What are the potential side effects?

While side effects are not explicitly listed here, potential risks may include allergic reactions similar to those from peony root or Glycyrrhiza since individuals with such allergies are excluded from participating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My lung function is at least 45% of what is considered normal.

Select...

I am willing to stop taking Mexiletine, Quinine, or Ranolazine for the study.

Select...

I am between 20 and 84 years old.

Select...

I have been diagnosed with ALS, PMA, or PLS.

Select...

I experience daily muscle cramps.

Select...

I have been on a stable dose of my ALS medication for at least a month.

Select...

I can swallow liquids or receive them through a feeding tube.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of low potassium or I'm currently taking potassium supplements.

Select...

I have been found unable to make my own medical decisions.

Select...

I understand and am willing to sign the informed consent.

Select...

I am not taking any experimental drugs for muscle cramps.

Select...

I have kidney or liver problems.

Select...

I do not have any active diseases needing treatment, other than ALS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 2, week 5, week 8 and week 11

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 2, week 5, week 8 and week 11

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2, week 5, week 8 and week 11 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Visual Analog Scale (MCS-VAS) Score

Secondary study objectives

Change in ALSAQ-5 (Quality of Life Questionnaire) Score

Change in ALSFRS-R Score

Change in Clinical Global Impression of Changes (CGIC) Score

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment sequence TJ-68-Placebo-Placebo-TJ-68Experimental Treatment2 Interventions

Employing an N-of-1, crossover design, each participant in the TJ-68 clinical trial will serve as his/her control. The participation will last for 11 weeks - four, 2-week treatment periods with 1-week washout (WO) period between each treatment period. Participants (n=13) will be randomized to the following treatment sequences: TJ-68, placebo, placebo, TJ-68 (1 week WO between each treatment period)

Group II: Treatment sequence Placebo-TJ-68-TJ-68-PlaceboExperimental Treatment2 Interventions

Employing an N-of-1, crossover design, each participant in the TJ-68 clinical trial will serve as his/her control. The participation will last for 11 weeks - four, 2-week treatment periods with 1-week washout (WO) period between each treatment period. Participants (n=13) will be randomized to the following treatment sequences: placebo, TJ-68, TJ-68, placebo (1 week WO between each treatment period)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 13Eligibility criteria met