A Widely Inclusive, Hybrid-Decentralized Pilot Trial Utilizing β-hydroxy-β-methylbutyrate to Lower IGFBP7 Levels in People With ALS

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

This is an open label trial of a supplement called HMB in patients with ALS. The researchers are evaluating its safety and tolerability, as well as its ability to lower insulin-like growth-factor binding protein 7 (IGFBP7) and Neurofilament light chain levels (NFL) and to slow ALS Functional Rating Scale, Revised (ALSFRS-R) progression.

Eligibility criteria

Qualifiers

Male or female aged at least 18 years.

Sporadic or familial ALS diagnosed as per Gold Coast Criteria (37).

Patient is able to understand and express informed consent (in the opinion of the site investigator).

Patient is able to read and write English.

Disqualifiers

Actively or recently (within past 30 days) participating in another intervention trial.

Currently or recently (within 30 days) taking HMB

Prior side effects from HMB deemed to be significant by the investigator

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.

Trial design

Treatments tested in this trial

  • β-hydroxy-β-methylbutyrate (HMB)

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators

Duke University

Lead sponsor

Temple University

Collaborator