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Curcumin

Theracurmin HP for Amyotrophic Lateral Sclerosis

Phase 2

Waitlist Available

Led By Richard Bedlack, MD, PhD

Research Sponsored by Richard Bedlack, M.D., Ph.D.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 1, month 6

Awards & highlights

No Placebo-Only Group

Summary

This trial will test Theracurmin capsules taken regularly over several months in people with ALS. Theracurmin may help by reducing inflammation and protecting cells from damage.

Eligible Conditions

Amyotrophic Lateral Sclerosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 1, month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 1, month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 1, month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in ALSFRS-R Slope

Secondary study objectives

Enrollment Rate

Faith's Phylogenetic Diversity of the Oral Microbiome

Faith's Phylogenetic Diversity of the Stool Microbiome

+9 more

Side effects data

From 2022 Phase 2 trial • 100 Patients • NCT04499963

22%

Diarrhea, loose stools

COVID Infection

Hot flashes

Increased weakness

Itching

Malaise

Flu-like symptoms

Pulmonary embolus

Rash

Constipation

Anxiety

Abdominal pain

Headache

Cramps

100%

80%

60%

40%

20%

Study treatment Arm

Open Label Arm

Healthy Control Arm

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Open Label ArmExperimental Treatment1 Intervention

The intervention is twice daily dosage of Theracurmin 90 mg capsules. This same dose was used in a successful trial of patients with mild cognitive impairment. Theracurmin HP capsules containing 90 mg curcumin each that will be taken as one capsule twice daily for 6 months. Each capsule contains 300 mg Theracurmin enhanced bioavailable water-dispersible turmeric rhizome complex providing 30% curcumin (90 mg). The content of Theracurmin HP has been independently certified by NSF International under NSF/ANSI 173.

Group II: Healthy Control ArmActive Control1 Intervention

We will seek to enroll 50 healthy control participants. We will attempt to enroll one control subject from each enrolled primary participant's home, preferably a spouse or partner of similar age if possible. We plan to use this data to compare the microbiome of control participants to that of the ALS participants at baseline, week 4 and month 6. We will not conduct further follow-up or collect additional samples with the control subjects.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Theracurmin HP

2020

Completed Phase 2

~100

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