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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

Summary

This study is evaluating whether a virtual reality program may help individuals with autism spectrum disorder.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in ALSFRS-R Slope
Secondary outcome measures
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%
Increased weakness
4%
Itching
2%
Cramps
2%
Malaise
2%
Flu-like symptoms
2%
Headache
2%
Constipation
2%
Abdominal pain
2%
Pulmonary embolus
2%
Rash
2%
Anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open Label Arm
Healthy Control Arm

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
~21 spots leftby Jul 2025