Trial Summary
What is the purpose of this trial?
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 Criteria
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.Inclusion Criteria
I am willing to stop using OTC products with peony root or Glycyrrhiza.
I understand and am willing to sign the informed consent.
My lung function is at least 45% of what is considered normal.
See 11 more
Exclusion Criteria
I do not have any active diseases needing treatment, other than ALS.
Screening albumin below normal laboratory level either at the Columbia or Mayo Clinic laboratory
I am not taking any medication that increases the risk of low potassium or pseudoaldosteronism, except for potassium-sparing diuretics.
See 12 more
Treatment Details
Interventions
- Placebo (Other)
- TJ-68 (Herbal Medicine)
Trial OverviewThe 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.
Participant Groups
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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo ClinicJacksonville, FL
Columbia University Irving Medical CenterNew York, NY
Mayo ClinicScottsdale, AZ
Loading ...
Who Is Running the Clinical Trial?
Hiroshi MitsumotoLead Sponsor
Tsumura & Co., Tokyo, JapanCollaborator