Phase 2
N=60
ALS Reversals - Lunasin Regimen
ALS (Amyotrophic Lateral Sclerosis)
Bottom Line
View on ClinicalTrials.gov: NCT02709330 ↗Enrolled (actual)
60
Serious AEs
26.0%
Results posted
Dec 2018
Primary outcome: Primary: Change in Revised ALS Functional Rating Scale (ALSFRS-R) — 0.44 points per month — p=0.99
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lunasin Regimen (Drug); Historical control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Richard Bedlack, M.D., Ph.D.
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Revised ALS Functional Rating Scale (ALSFRS-R) |
0.44 | 0.99 |
| SECONDARY Change in H3 Histone Acetylation |
0.993; 1.252; 1.795 | 0.0748 |
| SECONDARY Percent Agreement Between the Weights Obtained by Patients and Study Coordinator |
99.47; 99.05 | <0.00001 sig |
| SECONDARY Enrollment Rate |
9.1 | — |
| SECONDARY Retention Rate |
84 | — |
| SECONDARY Frequency of ALS Reversals |
— | — |
| SECONDARY ALSFRS-R Accuracy |
99.39 | <0.00001 sig |
Summary
This is a 12-month, widely inclusive, largely virtual, single-center, open-label pilot trial utilizing a historical control group. Participants will receive a Lunasin regimen and will be asked to register for an account of PatientsLikeMe website, where after the initial in-clinic visit, they will be asked to enter specific data.
Eligibility Criteria
Inclusion Criteria
- Male or female, aged at least 18 years.
- Sporadic or familial ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria.
- Patient is able to understand and express informed consent (in the opinion of the site investigator).
- Patient has access to the Internet on a desktop computer, laptop, or tablet and has a working email address.
- Patient or caregiver is willing and able to use a computer and enter data on a secure website.
- Patient is able to read and write English.
- Women must not be able to become pregnant (e.g., post-menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study and three months after study completion. Adequate contraception includes: abstinence, hormonal contraception (oral contraception, implanted contraception, injected contraception or other hormonal contraception, for example patch or contraceptive ring), intrauterine device (IUD) in place for ≥ 3 months, barrier method in conjunction with spermicide, or another adequate method.
Exclusion Criteria
- Patient is taking other experimental treatments for ALS.
- Prior side effects from Lunasin.
- Known soy allergy.
- Patient has a medical or psychiatric illness that could in the investigator's opinion interfere with the patient's ability to participate in this study.
- Pregnant women or women currently breastfeeding.
Data sourced from ClinicalTrials.gov (NCT02709330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.