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

NCT ID: NCT04499963

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-28
• Study Completion Date: 2022-08-30

Brief Summary

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

Detailed Description

This will be a 6-month, widely inclusive, virtual, single-center, open-label pilot trial utilizing a historical control group. Following informed consent and screening, participants with ALS will take Theracurmin 1 capsule (90mg) twice daily for 6-months. Treatment with the Theracurmin and all study outcome measures and labs are being performed exclusively for research purposes. Collected data includes saliva and stool microbiome sampling, adverse events, concomitant medications, weight and height, Theracurmin treatment evaluations, and Thrive Questionnaires. Participants will be asked to register on the website Patientslikeme.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open Label Arm

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 Type: EXPERIMENTAL

Theracurmin HP

Intervention Type: DRUG

The intervention is based on the twice daily dosage of Theracurmin 90 mg capsules used in a trial of patients with mild cognitive impairment

Healthy Control Arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Theracurmin HP

The intervention is based on the twice daily dosage of Theracurmin 90 mg capsules used in a trial of patients with mild cognitive impairment

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Richard Bedlack, M.D., Ph.D.

OTHER

Sponsor Role: lead

Responsible Party

Richard Bedlack, M.D., Ph.D.

Professor of Neurology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Richard Bedlack, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00103700

Identifier Type: -

Identifier Source: org_study_id