|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02709330 |
|
Date of registration:
|
05/03/2016 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
ALS Reversals - Lunasin Regimen
|
|
Scientific title:
|
An Open-label, Single-center, 12-month Trial of a Lunasin Regimen for Patients With Amyotrophic Lateral Sclerosis (ALS) |
|
Date of first enrolment:
|
April 2016 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02709330 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Richard Bedlack, M.D., Ph.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Associate Professor of Neurology |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
ALS (Amyotrophic Lateral Sclerosis)
|
|
Intervention(s)
|
|
Other: Historical control
|
|
Drug: Lunasin Regimen
|
|
Primary Outcome(s)
|
|
Change in Revised ALS Functional Rating Scale (ALSFRS-R)
[Time Frame: Screening/baseline - 12 months]
|
|
Secondary Outcome(s)
|
|
ALSFRS-R Accuracy
[Time Frame: Month 1]
|
|
Enrollment Rate
[Time Frame: Screening/baseline - Month 12]
|
|
Frequency of ALS Reversals
[Time Frame: Screening/baseline - Month 12]
|
|
Retention Rate
[Time Frame: Month 12]
|
|
Percent Agreement Between the Weights Obtained by Patients and Study Coordinator
[Time Frame: Month 1, Month 12]
|
|
Change in H3 Histone Acetylation
[Time Frame: Screening/baseline, Month 1]
|
|
Secondary ID(s)
|
|
Pro00063754
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|