NCT04499963

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Richard Bedlack, M.D., Ph.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2020-08-28
• Primary completion: 2022-08-30
• Completion: 2022-08-30
• First posted: 2020-08-05
• Last updated: 2023-09-28
• Results posted: 2023-09-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study