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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 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
6%
COVID Infection
6%
Hot flashes
4%
Itching
4%
Increased weakness
2%
Malaise
2%
Flu-like symptoms
2%
Anxiety
2%
Pulmonary embolus
2%
Rash
2%
Constipation
2%
Abdominal pain
2%
Headache
2%
Cramps
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Richard Bedlack, M.D., Ph.D.Lead Sponsor
2 Previous Clinical Trials
75 Total Patients Enrolled
2 Trials studying Amyotrophic Lateral Sclerosis
75 Patients Enrolled for Amyotrophic Lateral Sclerosis
Richard Bedlack, MD, PhDPrincipal InvestigatorDuke University
~20 spots leftby Oct 2025
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