A Clinical Trial to Evaluate NB-4746 in Participants With Amyotrophic Lateral Sclerosis. (NCT07369076)
A Phase 1b/2 Study to Evaluate NB-4746 in Participants With Amyotrophic Lateral Sclerosis.
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this trial is to learn about the effects of NB-4746 compared with placebo in people with amyotrophic lateral sclerosis. The questions this trial aims to answer in comparing NB-4746 to placebo are: * What adverse events associated with taking NB-4746 are reported during this trial? (An adverse event is any sign or symptom that participants have during a trial. Adverse events may or may not be caused by treatments in the trial.) * How does NB-4746 move into, through, and out of the body of the participants? * What is the change in the level of neurofilament light (NfL) in the participants' blood? (NfL is a marker used to measure the extent of damage to the nerve cells.) This trial has 2 parts. The trial doctors will start Part A before starting Part B of the trial. Participants have an option to enter the open label extension after completing Part A or Part B. Part A: Participants will be randomly placed into 1 of the 3 groups. There are equal chances to be assigned to either group. Group 1: Participants will receive NB-4746 capsules at a low dose to take by mouth twice daily for 1 month. Group 2: Participants will receive NB-4746 capsules at a high dose to take by mouth twice daily for 1 month. Group 3: Participants will receive placebo capsules to take twice daily for approximately 1 month. Part B: Participants will be randomly placed into 1 of the 2 groups. There are equal chances to be assigned to either group. Group 1: Participants will receive NB-4746 capsules at a dose determined by Part A to take by mouth twice daily for 12 weeks. Group 2: Participants will receive placebo capsules to take twice daily for approximately 12 weeks. None of the participants, trial doctors, or trial staff will know which treatment the participants will receive during Part A or B. Some trials are done this way because knowing what treatment the participants receive can affect the results of the trial. Doing a trial this way helps to make sure that the results are looked at with fairness across all treatments. Open-Label Extension: Upon the completion of Part A or Part B, the doctor will verify the participant's willingness to continue receiving study treatment. This open label extension continues until each participant completes up to 1 year of treatment. The trial doctors will check participants' ALS and general health throughout the trial.
Who can join: Review the eligibility criteria below.
Location: Concord Repatriation General Hospital — Concord, New South Wales
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (8 Sites)
- Concord Repatriation General Hospital — Concord, New South Wales
- Neuroscience Research Australia — Randwick, New South Wales
- Royal Brisbane and Women's Hospital — Brisbane, Queensland
- Flinders Medical Centre — Bedford Park, South Australia
- Calvery Health care Bethlehem — Caulfield South, Victoria
- Perron Institute — Nedlands, Western Australia
- Stan Cassidy Center for Rehabilitation — Fredericton, New Brunswick
- Genge Partners — Montreal, Quebec
📞 Contact the Study Coordinator
Phone: (801) 918-7637
Email: lmehta@nurabio.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Amyotrophic Lateral Sclerosis (ALS)
- HEALEY ALS Platform Trial - Regimen I NUZ-001 — Boston, Massachusetts
- A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS) — La Jolla, California
- Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY) — Phoenix, Arizona
- Resiliency Intervention for Patients With ALS and Their Care-Partners — Boston, Massachusetts
- Safety Study of XT-150 in Participants With ALS — Phoenix, Arizona
- A Phase Ⅰ/Ⅱa Study of SNUG01 in Adult Subjects With ALS — Boston, Massachusetts
Explore by condition: All Amyotrophic Lateral Sclerosis (ALS) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.