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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

September 30, 2022

Primary Completion Date

July 26, 2024

Study Completion Date

July 26, 2024

Conditions
Amyotrophic Lateral SclerosisMuscle Cramp
Interventions
DRUG

TJ-68

For two periods (one period = 2 weeks) during the 11-week participation, participants will take 2.5 g of TJ-68 for three times per day before meals. It will be administered by dissolving 2.5 g of TJ-68 powder in 1 oz. of lukewarm water.

DRUG

Placebo

For two periods (one period = 2 weeks) during the 11-week participation, participants will take 2.5 g of placebo for three times per day before meals. It will be administered by dissolving 2.5 g of the placebo powder in 1 oz. of lukewarm water.

Trial Locations (3)

10032

Columbia University Irving Medical Center, New York

32224

Mayo Clinic, Jacksonville

85259

Mayo Clinic, Scottsdale

All Listed Sponsors
collaborator

Tsumura & Co., Tokyo, Japan

UNKNOWN

lead

Hiroshi Mitsumoto

OTHER