A Phase 1/2 interventional study of TJ-68 and Placebo in Amyotrophic Lateral Sclerosis and Muscle Cramp, sponsored by Hiroshi Mitsumoto. Completed at 3 sites in United States. Open to participants aged 20 Years to 84 Years. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by Hiroshi Mitsumoto · Phase 1/2, Interventional, and Treatment
Among 438 studies in Amyotrophic Lateral Sclerosis with a site in United States — 98 open to participants now, 129 under way, 11 of them phase 3. Amyotrophic Lateral Sclerosis · United States.
Among the 438 studies in Amyotrophic Lateral Sclerosis with a site in United States, this one is the 244th largest by enrollment of the 306 interventional ones, is one of 19 that started in 2022, is one of 32 in phase 1/2, and was the 298th registered.
978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.
This study's enrollment of 11 is below the median of 38 across 662 interventional studies indexed under Amyotrophic Lateral Sclerosis.
Browse Amyotrophic Lateral Sclerosis studies →98 of the 438 studies in Amyotrophic Lateral Sclerosis with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 192 Amyotrophic Lateral Sclerosis studies recruiting now, 117 (61%) set no upper age limit and 23 (12%) stop at 75 or younger; 15 take children under 18; 55 take healthy volunteers.
This study: 20 Years to 84 Years · all sexes · no healthy volunteers.
The full table on the hub →438 studies; the count open now beside each. This study's row is marked.
First in 1982; this study’s year is marked. 19 started in 2022.
Median enrollment 34 across the 306 interventional studies, 100 across the 120 observational. Of the 277 that completed or were terminated, 102 (37%) have results posted.
163 of 438 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Hiroshi Mitsumoto as lead sponsor.
Hiroshi Mitsumoto has 1 study filed under Amyotrophic Lateral Sclerosis — fewer than ten, so there is no comparison to draw.
42 of the studies in Amyotrophic Lateral Sclerosis with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07161999Phase 3Coya TherapeuticsStudy of COYA 302 for the Treatment of ALS | 2027-04 |
| NCT04057898Phase 3MediciNovaEvaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS | 2027-04 |
| NCT04297683Phase 3Merit E. Cudkowicz, MDHEALEY ALS Platform Trial - Master Protocol | 2027-07 |
| NCT07410806Phase 3Merit E. Cudkowicz, MDHEALEY ALS Platform Trial - Regimen I NUZ-001 | 2027-07-01 |
| NCT04220190Phase 3Rapa Therapeutics LLCRAPA-501 Therapy for ALS | 2027-07-01 |
Among the 438 studies in Amyotrophic Lateral Sclerosis with a site in United States, from their registry updates:
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.
In Japan, TJ-68 is a common Kampo medicine prescribed by Japanese physicians to manage muscle cramps or pain of diverse origins. In the USA, there are no effective medications to control muscle cramps and no approved medications to specifically treat muscle cramps. Quinine sulfate and Mexiletine have shown some effect with additional safety considerations. The fact that TJ-68 has been commonly used for the treatment of muscle cramps in Japan and the lack of available medications for cramps in ALS represent the fundamental rationale for this proposal.
This is a phase 1/2, two-site, double-blinded, randomized, placebo-controlled, multi-period crossover clinical trial for individuals with ALS and muscle cramps. Participants will be enrolled in the study for 11 weeks and receive TJ-68, also known as Shakuyakukanzoto - a kampo, herbal medicine - to assess its effect in relieving muscle cramps. This clinical trial employs N-of-1 study design in which all participants will receive TJ-68 and placebo at certain points, serving as their own controls.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Drug: TJ-68 · Drug: Placebo
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)
Drug: TJ-68 · Drug: Placebo
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.
Also known as: Shakuyakukanzoto
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.
Also known as: Placebo Tablet
Visual Analog Scale (MCS-VAS) Score
This is designed to measure improvements in muscle cramps. MCS-VAS indicates the level to which muscle cramps affect overall daily activity. The score ranges from 0 to 10; 0 indicates no interference and 10 indicates severe interference with overall daily activity. MCS-VAS will be administered by a trained evaluator to reduce recall bias and lack of insight, which can limit subjective assessments. To minimize carryover effects, results reflect the average of the scores taken at the second week of each treatment period.
Time frame: Assessed at Baseline, Week 2, Week 5, Week 8 and Week 11; Week 2 reported
Overall Muscle Cramp Scale (MCS) Score
Changes in trigger, frequency, severity, and location of muscle cramps will be measured by administering all of MCS questions. Motor behaviors which trigger muscle cramps and muscle cramps' effects on sleep quality will also be measured. The score for each component of MCS -- trigger, frequency, severity, location, behavior, and effect on sleep quality -- will range from 1 to 5, with the severity increasing from 1 to 5. The total score range is 6 to 30. All of the MCS components will be administered by a trained evaluator and evaluated by the investigator. To minimize carryover effects, results reflect the average of the scores taken at the second week of each treatment period.
Time frame: Assessed at Baseline, Week 2, Week 5, Week 8 and Week 11; Week 2 reported
Self-reported Cramp Pain Score
Cramp pain will be measured on a scale of 0 to 10 with 0 indicating no pain and 10 indicating severe pain. To minimize carryover effects, results reflect the average of the scores taken at the second week of each treatment period.
Time frame: Assessed at Baseline, Week 2, Week 5, Week 8 and Week 11; Week 2 reported
ALSFRS-R Score
Changes in functionality due to disease progression will be measured by administering ALSFRS-R to participants. ALSFRS-R includes 12 questions that can have a score of 0 to 4. A score of 0 on a question would indicate no function while a score of 4 would indicate full function. Total score range is 0 to 48. To minimize carryover effects, results reflect the average of the scores taken at the second week of each treatment period.
Time frame: Assessed at Baseline, Week 2, Week 5, Week 8 and Week 11; Week 2 reported
Clinical Global Impression of Changes (CGIC) Score
Changes in participant's feelings since the start of dosing will be measured by using a score of 1 to 7 with 1 indicating "very much improved" and 7 indicating "very much worse." To minimize carryover effects, results reflect the average of the scores taken at the second week of each treatment period.
Time frame: Assessed at Baseline, Week 2, Week 5, Week 8 and Week 11; Week 2 reported
ALSAQ-5 (Quality of Life Questionnaire) Score
Participants' motor functions and resulting quality of life will be measured by asking questions about their ability to perform certain tasks or feelings of hopelessness within the last two weeks. Participants can answer by saying never, rarely, sometimes, often, or always/cannot do at all. The ALSAQ-5 full score range is from 0 to 100, with 0 reflecting the best health state. To minimize carryover effects, results reflect the average of the scores taken at the second week of each treatment period.
Time frame: Assessed at Baseline, Week 2, Week 5, Week 8 and Week 11; Week 2 reported
Goal Attainment Scale (GAS) Score
Participant and the evaluator will collaborate and establish a goal. Progression of goal achievement will be measured over the course of participation and scored from -2 to +2 with -2 indicating "(achievement) much worse than expected" and +2 indicating "(achievement) much better than expected." To minimize carryover effects, results reflect the average of the scores taken at the second week of each treatment period.
Time frame: Assessed at Baseline, Week 2, Week 5, Week 8 and Week 11; Week 2 reported
| Milestone | Treatment Sequence TJ-68-Placebo-Placebo-TJ-68 | Treatment Sequence Placebo-TJ-68-TJ-68-Placebo |
|---|---|---|
| Started | 6 | 5 |
| Completed | 6 | 5 |
| Not completed | 0 | 0 |
| Milestone | Treatment Sequence TJ-68-Placebo-Placebo-TJ-68 | Treatment Sequence Placebo-TJ-68-TJ-68-Placebo |
|---|---|---|
| Started | 6 | 5 |
| Completed | 6 | 5 |
| Not completed | 0 | 0 |
| Milestone | Treatment Sequence TJ-68-Placebo-Placebo-TJ-68 | Treatment Sequence Placebo-TJ-68-TJ-68-Placebo |
|---|---|---|
| Started | 6 | 5 |
| Completed | 6 | 5 |
| Not completed | 0 | 0 |
| Milestone | Treatment Sequence TJ-68-Placebo-Placebo-TJ-68 | Treatment Sequence Placebo-TJ-68-TJ-68-Placebo |
|---|---|---|
| Started | 6 | 5 |
| Completed | 6 | 5 |
| Not completed | 0 | 0 |
| Milestone | Treatment Sequence TJ-68-Placebo-Placebo-TJ-68 | Treatment Sequence Placebo-TJ-68-TJ-68-Placebo |
|---|---|---|
| Started | 6 | 5 |
| Completed | 6 | 5 |
| Not completed | 0 | 0 |
| Milestone | Treatment Sequence TJ-68-Placebo-Placebo-TJ-68 | Treatment Sequence Placebo-TJ-68-TJ-68-Placebo |
|---|---|---|
| Started | 6 | 5 |
| Completed | 6 | 5 |
| Not completed | 0 | 0 |
| Milestone | Treatment Sequence TJ-68-Placebo-Placebo-TJ-68 | Treatment Sequence Placebo-TJ-68-TJ-68-Placebo |
|---|---|---|
| Started | 6 | 5 |
| Completed | 6 | 5 |
| Not completed | 0 | 0 |
This is designed to measure improvements in muscle cramps. MCS-VAS indicates the level to which muscle cramps affect overall daily activity. The score ranges from 0 to 10; 0 indicates no interference and 10 indicates severe interference with overall daily activity. MCS-VAS will be administered by a trained evaluator to reduce recall bias and lack of insight, which can limit subjective assessments. To minimize carryover effects, results reflect the average of the scores taken at the second week of each treatment period.
| score on a scale | Placebo | TJ-68 |
|---|---|---|
| Visual Analog Scale (MCS-VAS) Score | 2.07 ± 2.03 | 1.7 ± 1.91 |
Changes in trigger, frequency, severity, and location of muscle cramps will be measured by administering all of MCS questions. Motor behaviors which trigger muscle cramps and muscle cramps' effects on sleep quality will also be measured. The score for each component of MCS -- trigger, frequency, severity, location, behavior, and effect on sleep quality -- will range from 1 to 5, with the severity increasing from 1 to 5. The total score range is 6 to 30. All of the MCS components will be administered by a trained evaluator and evaluated by the investigator. To minimize carryover effects, results reflect the average of the scores taken at the second week of each treatment period.
| score on a scale | Placebo | TJ-68 |
|---|---|---|
| Overall Muscle Cramp Scale (MCS) Score | 14.7 ± 5.07 | 13.1 ± 5.81 |
Cramp pain will be measured on a scale of 0 to 10 with 0 indicating no pain and 10 indicating severe pain. To minimize carryover effects, results reflect the average of the scores taken at the second week of each treatment period.
| score on a scale | Placebo | TJ-68 |
|---|---|---|
| Self-reported Cramp Pain Score | 0.59 ± 0.41 | 0.49 ± 0.46 |
Changes in functionality due to disease progression will be measured by administering ALSFRS-R to participants. ALSFRS-R includes 12 questions that can have a score of 0 to 4. A score of 0 on a question would indicate no function while a score of 4 would indicate full function. Total score range is 0 to 48. To minimize carryover effects, results reflect the average of the scores taken at the second week of each treatment period.
| score on a scale | Placebo | TJ-68 |
|---|---|---|
| ALSFRS-R Score | 34.1 ± 5.37 | 34.5 ± 5.39 |
Changes in participant's feelings since the start of dosing will be measured by using a score of 1 to 7 with 1 indicating "very much improved" and 7 indicating "very much worse." To minimize carryover effects, results reflect the average of the scores taken at the second week of each treatment period.
| score on a scale | Placebo | TJ-68 |
|---|---|---|
| Clinical Global Impression of Changes (CGIC) Score | 3.48 ± 1.24 | 2.95 ± 1.28 |
Participants' motor functions and resulting quality of life will be measured by asking questions about their ability to perform certain tasks or feelings of hopelessness within the last two weeks. Participants can answer by saying never, rarely, sometimes, often, or always/cannot do at all. The ALSAQ-5 full score range is from 0 to 100, with 0 reflecting the best health state. To minimize carryover effects, results reflect the average of the scores taken at the second week of each treatment period.
| score on a scale | Placebo | TJ-68 |
|---|---|---|
| ALSAQ-5 (Quality of Life Questionnaire) Score | 4.83 ± 2.39 | 5 ± 3.05 |
Participant and the evaluator will collaborate and establish a goal. Progression of goal achievement will be measured over the course of participation and scored from -2 to +2 with -2 indicating "(achievement) much worse than expected" and +2 indicating "(achievement) much better than expected." To minimize carryover effects, results reflect the average of the scores taken at the second week of each treatment period.
| score on a scale | Placebo | TJ-68 |
|---|---|---|
| Goal Attainment Scale (GAS) Score | 0.50 ± 1.14 | 0.67 ± 1.11 |
Collected over 11 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/11 (0%) | 0/11 (0%) | 3/11 (27.3%) |
| TJ-68 | 0/11 (0%) | 2/11 (18.2%) | 5/11 (45.5%) |
| Event | Placebo | TJ-68 |
|---|---|---|
| Respiratory distress due to RSVInfections and infestations | 0/11 | 1/11 |
| Diverticulitis with pericecal abscessGastrointestinal disorders | 0/11 | 1/11 |
| Event | Placebo | TJ-68 |
|---|---|---|
| Facial rashGeneral disorders | 0/11 | 1/11 |
| Abdominal bloatingGastrointestinal disorders | 0/11 | 1/11 |
| StomachacheGastrointestinal disorders | 0/11 | 1/11 |
| Elevated blood pressureGeneral disorders | 0/11 | 1/11 |
| Flu-like symptomsGeneral disorders | 1/11 | 1/11 |
| Joint painGeneral disorders | 0/11 | 1/11 |
| Scleral erythemaEye disorders | 0/11 | 1/11 |
| COVID-19Infections and infestations | 1/11 | 0/11 |
| FatigueGeneral disorders | 1/11 | 0/11 |
| SinusitisGeneral disorders | 1/11 | 0/11 |
| Age, Continuous(years) | Treatment Sequence TJ-68-Placebo-Placebo-TJ-68 | Treatment Sequence Placebo-TJ-68-TJ-68-Placebo | Total |
|---|---|---|---|
| Mean | 63 ± 8.15 | 62.8 ± 7.29 | 62.9 ± 7.38 |
| Sex: Female, Male(Participants) | Treatment Sequence TJ-68-Placebo-Placebo-TJ-68 | Treatment Sequence Placebo-TJ-68-TJ-68-Placebo | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 2 | 1 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Treatment Sequence TJ-68-Placebo-Placebo-TJ-68 | Treatment Sequence Placebo-TJ-68-TJ-68-Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 4 | 4 | 8 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Treatment Sequence TJ-68-Placebo-Placebo-TJ-68 | Treatment Sequence Placebo-TJ-68-TJ-68-Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 5 | 5 | 10 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Treatment Sequence TJ-68-Placebo-Placebo-TJ-68 | Treatment Sequence Placebo-TJ-68-TJ-68-Placebo | Total |
|---|---|---|---|
| United States | 6 | 5 | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2022 to primary completion in Jul 2024, 21 months.
Results were first posted in May 2025, 9 months after primary completion.
Of 36 phase 1/2 interventional studies under Amyotrophic Lateral Sclerosis, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 57. This study's 21 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Amyotrophic Lateral Sclerosis →