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

NCT04499963 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: Pro00103700
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change in ALSFRS-R Slope

  The ALSFRS-R (ALS Functional Rating Scale-Revised) will be determined at all video/telephone visits. ALSFRS-R is a quickly administered (five minute) ordinal rating scale (ratings 0-4) used to determine patients' assessments of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Change in ALSFRS-R scores correlate with change in strength over time, and it is closely associated with quality of life measures and predicted survival. Each task is rated on a five-point scale from 0 = can't do, to 4 = normal ability. Individual item scores are summed to produce a reported score of between 0=worst and 48=best.

  Starting at week 4 and then once every 30 days for 6 months

Secondary Outcomes (12)

• Number of Participants With ALS Reversal

  Month 6

• Total Number of Adverse Events as Measured by Patient Reporting

  up to 6 months

• Enrollment Rate

  up to 6 months

• Retention as Measured by the Number of Participants Who Completed the 6 Month Study Visit

  month 6

• Shannon Diversity Index of the Oral Microbiome

  Baseline, month 1, month 6

Study Arms (2)

Open Label Arm

EXPERIMENTAL

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.

Drug: Theracurmin HP

Healthy Control Arm

NO 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.

Interventions

Theracurmin HP 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

Open Label Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Richard Bedlack, M.D., Ph.D.: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Richard Bedlack, MD, PhD
• Organization: Duke University

richard.bedlack@duke.edu

919-668-2839

Study Officials

• Richard Bedlack, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurology

Model Details: This will be a 6-month, widely inclusive, largely remote/virtual, single-center, open-label pilot trial utilizing a historical control group.

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 5, 2020
• Study Start: August 28, 2020
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)