Phase 2 N=100 Treatment

Trial of Theracurmin for Patients With Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic Lateral Sclerosis

Bottom Line

View on ClinicalTrials.gov: NCT04499963 ↗

Enrolled (actual)

100

Serious AEs

2.0%

Results posted

Sep 2023

Primary outcome: Primary: Change in ALSFRS-R Slope — 0.229; 0.224 ALSFRS-R points per week — p=0.984

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Theracurmin HP (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Richard Bedlack, M.D., Ph.D.
Primary completion: Aug 2022

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

Summary

This will be a 6-month, widely inclusive, virtual, single-center, open-label pilot trial utilizing a historical control group.

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).

View full record on ClinicalTrials.gov →

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.