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TJ-68 for Amyotrophic Lateral Sclerosis

Phase 1 & 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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

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

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I am between 20 and 84 years old.

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

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I experience daily muscle cramps.

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

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Visual Analog Scale (MCS-VAS) Score

Secondary outcome measures

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hiroshi MitsumotoLead Sponsor

Tsumura & Co., Tokyo, JapanUNKNOWN

Hiroshi Mistumoto, MD, Dsc.Principal InvestigatorColumbia University

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04998305 — Phase 1 & 2

Amyotrophic Lateral Sclerosis Research Study Groups: Treatment sequence TJ-68-Placebo-Placebo-TJ-68, Treatment sequence Placebo-TJ-68-TJ-68-Placebo

Amyotrophic Lateral Sclerosis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04998305 — Phase 1 & 2

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04998305 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have enrolled in this experiment?

"Affirmative. Clinicaltrials.gov contains evidence that this clinical trial, which was initially launched on September 30th 2022, is now enrolling patients. There are 26 positions available at 2 different medical centres."

Answered by AI

What are the requirements for participation in this experiment?

"For this clinical trial, a cohort of 26 adults aged 20-70 with limb cramping is being recruited. To qualify for the study, individuals must meet certain prerequisites including: Pass El Escorial ALS Diagnostic Criteria or revised Gold Coast ALS diagnostic criteria; Experience at least one muscle spasm per day; Possess Forced Vitals Capacity (FVC) greater than 45% in seated position; Ability to either swallow liquids orally or receive them through feeding tube; Have an available caregiver if speaking/writing become difficult due to condition; Comprehend and consent to terms verbally or via signature; Be willing to attend research site multiple times"

Answered by AI

Is the age criterion above 55 years old applicable to this research project?

"This clinical trial requires all participants to be aged between 20 and 70, in accordance with the pre-defined inclusion criteria."

Answered by AI

Are there opportunities for individuals to enrol in this research study?

"Affirmative. Clinicaltrials.gov data suggests that this research, which was initially made public on September 30th 2022, is actively enrolling participants. The trial requires 26 individuals to be enrolled across 2 different medical sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Hiroshi Mitsumoto 2022. "TJ-68 Clinical Trial in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle Cramps". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04998305.

All > Lou Gehrigs Disease > Als