At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 60 enrolled
Drug / intervention
Lunasin Regimen +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Single-center, 12-month Trial of a Lunasin Regimen for Patients With Amyotrophic Lateral Sclerosis (ALS)
In Brief
A Phase 2 clinical trial evaluating Lunasin Regimen and Historical control for ALS (Amyotrophic Lateral Sclerosis). Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsALS (Amyotrophic Lateral Sclerosis)
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartApr 2016
Primary CompletionSep 2017
TodayJul 2026
First PostedMar 16, 2016
Enrollment StartApr 1, 2016
Primary CompletionSep 13, 2017
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.3 years ago
Interventions
Lunasin Regimendrug
LunaRich X Capsules, Reliv Now, ProVantage
Historical controlother
Matched historical controls will be identified from the PatientsLikeMe database.