An Open-label, Single-center, 6-month Trial of Theracurmin for Patients With Amyotrophic Lateral Sclerosis (ALS)

Study Purpose:

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

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Enrolling

Phase:

Phase II

Study Chair(s)/Principal Investigator(s):

Richard Bedlack, MD, PhD Duke University

Clinicaltrials.gov ID (11 digit #):

NCT04499963

Neals Affiliated?

No

Coordinating Center Contact Information

Duke University Medical Center
Lisa Harrison, RN / .(JavaScript must be enabled to view this email address) / 919-613-2681
.(JavaScript must be enabled to view this email address) Durham, North Carolina 27705 United States

Full Study Summary:

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.

Study Sponsor:

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

Participant Duration:

6 months

Estimated Enrollment:

100

Estimated Study Start Date:

08/12/2020

Estimated Study Completion Date:

08/15/2021

Posting Last Modified Date:

08/16/2020

Date Study Added to alsconsortium.org:

08/16/2020
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


    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).

  • Site Contact Information

    Duke University Medical Center
    Lisa Harrison, RN / .(JavaScript must be enabled to view this email address) / 919-613-2681
    Durham, North Carolina 27705
    United States