Trial of Theracurmin for Patients With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: Theracurmin HP
Intervention description: The intervention is based on the twice daily dosage of Theracurmin 90 mg capsules used in a trial of patients with mild cognitive impairment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a 6-month, widely inclusive, largely remote/virtual, single-center, open-label pilot trial utilizing a historical control group.
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

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

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).