Phase 2
Completed N=100
Trial of Theracurmin for Patients With Amyotrophic Lateral Sclerosis (ALS)
Source: ClinicalTrials.gov NCT04499963 ↗Enrolled (actual)
100
Serious AEs
2.0%
Results posted
Sep 2023
Primary outcomePrimary: Change in ALSFRS-R Slope — 0.229; 0.224 ALSFRS-R points per week — p=0.984
Summary
This will be a 6-month, widely inclusive, virtual, single-center, open-label pilot trial utilizing a historical control group.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in ALSFRS-R Slope |
0.229; 0.224 | 0.984 |
| SECONDARY Number of Participants With ALS Reversal |
— | — |
| SECONDARY Total Number of Adverse Events as Measured by Patient Reporting |
25 | — |
| SECONDARY Enrollment Rate |
3.1 | — |
| SECONDARY Retention as Measured by the Number of Participants Who Completed the 6 Month Study Visit |
35 | — |
| SECONDARY Shannon Diversity Index of the Oral Microbiome |
4.7; 4.7; 4.7; 4.7 | >0.05 |
| SECONDARY Faith's Phylogenetic Diversity of the Oral Microbiome |
13.5; 12.8; 13.2; 12.7 | >0.5 |
| SECONDARY Observed Features (Amplicon Sequence Variants, ASV) of the Oral Microbiome |
121.4; 114.4; 115.1; 110.6 | >0.05 |
| SECONDARY Pielou's Evenness Index of the Oral Microbiome |
0.69; 0.69; 0.69; 0.70 | >0.05 |
| SECONDARY Shannon Diversity Index of the Stool Microbiome |
5.1; 5.3; 5.2; 5.2 | >0.05 |
| SECONDARY Faith's Phylogenetic Diversity of the Stool Microbiome |
10.8; 10.4; 10.8; 10.6 | >0.05 |
| SECONDARY Observed Features (Amplicon Sequence Variants, ASVs) of the Stool Microbiome |
146.1; 145.7; 148.2; 146.8 | >0.05 |
| SECONDARY Pielou's Evenness Index of the Stool Microbiome |
0.72; 0.74; 0.73; 0.73 | >0.05 |
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.
- Patient is expected to survive for the duration of the trial.
- Women must not be pregnant (will have evidence of a negative pregnancy test obtained by local physician within past 7 days or be post-menopausal)
- 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 (those that are part of an active research study).
- Prior side effects from curcumin or turmeric containing products
- 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.
- Life expectancy shorter than the duration of the trial.
- Taking an antiplatelet agent or anticoagulant (due to the theoretically increased risk of bleeding from curcumin products).
Data sourced from ClinicalTrials.gov (NCT04499963). 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. Informational only — not medical advice.