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Minor2 versionsRe-verified since Mar 18, 2026, no change to tracked fieldsv82-v83
MinorTrial status: Recruiting to Active, Not Recruitingv81
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MinorStart date changed from estimate of Feb 9, 2026 to Feb 2, 2026v80
MinorStart date: Feb 3, 2026 to Feb 9, 2026v79
MinorStart date: Feb 2, 2026 to Feb 3, 2026v78
MinorStart date: Feb 1, 2026 to Feb 2, 2026v77
MinorStart date: Jan 29, 2026 to Feb 1, 2026v76
MinorStart date: Jan 28, 2026 to Jan 29, 2026v75
MinorStart date: Jan 27, 2026 to Jan 28, 2026v74
MinorStart date: Jan 26, 2026 to Jan 27, 2026v73
MinorStart date: Jan 22, 2026 to Jan 26, 2026v72
MinorStart date: Jan 21, 2026 to Jan 22, 2026v71
MinorStart date: Jan 20, 2026 to Jan 21, 2026v70
MinorStart date: Jan 19, 2026 to Jan 20, 2026v69
MinorStart date: Jan 18, 2026 to Jan 19, 2026v68
MinorStart date: Jan 15, 2026 to Jan 18, 2026v67
MinorStart date: Jan 14, 2026 to Jan 15, 2026v66
MinorStart date: Jan 13, 2026 to Jan 14, 2026v65
MinorStart date: Jan 12, 2026 to Jan 13, 2026v64
MinorStart date: Jan 11, 2026 to Jan 12, 2026v63
MinorStart date: Jan 8, 2026 to Jan 11, 2026v62
MinorStart date: Jan 6, 2026 to Jan 8, 2026v61
MinorStart date: Jan 5, 2026 to Jan 6, 2026v60
MinorStart date: Jan 4, 2026 to Jan 5, 2026v59
MinorStart date: Jan 1, 2026 to Jan 4, 2026v58
MinorStart date: Dec 30, 2025 to Jan 1, 2026v57
MinorStart date: Dec 29, 2025 to Dec 30, 2025v56
MinorStart date: Dec 28, 2025 to Dec 29, 2025v55
MinorStart date: Dec 25, 2025 to Dec 28, 2025v54
MinorStart date: Dec 24, 2025 to Dec 25, 2025v53
MinorStart date: Dec 23, 2025 to Dec 24, 2025v52
MinorStart date: Dec 22, 2025 to Dec 23, 2025v51
MinorStart date: Dec 21, 2025 to Dec 22, 2025v50
MinorStart date: Dec 18, 2025 to Dec 21, 2025v49
MinorStart date: Dec 16, 2025 to Dec 18, 2025v48
MinorStart date: Dec 15, 2025 to Dec 16, 2025v47
MinorStart date: Dec 14, 2025 to Dec 15, 2025v46
MinorStart date: Dec 11, 2025 to Dec 14, 2025v45
MinorStart date: Dec 10, 2025 to Dec 11, 2025v44
MinorStart date: Dec 9, 2025 to Dec 10, 2025v43
MinorStart date: Dec 8, 2025 to Dec 9, 2025v42
MinorStart date: Dec 7, 2025 to Dec 8, 2025v41
MinorStart date: Dec 3, 2025 to Dec 7, 2025v40
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background:
Amyotrophic lateral sclerosis (ALS) is a disorder that damages nerve cells in the brain and spinal cord. It can cause muscle weakness, paralysis, and loss of movement. The symptoms grow worse over time. Half of all people with ALS live only 3 to 5 years after diagnosis. Current drug treatments can slow the progress of the disease, but they cannot stop or reverse it.
Objective:
To test a study drug (acamprosate) in people with ALS with a mutation in the C9orf72 gene.
Eligibility:
People aged 18 years and older with ALS. They must have a mutation in the C9orf72 gene.
Design:
Participants will have 13 visits over 32 weeks. Five visits will be at the clinic, and 8 visits will be by phone.
Participants will have a baseline visit of up to 3 days. They will have a physical exam with blood tests. They will have imaging scans and tests of their breathing ability. Their memory, thinking, and behavior will be assessed. They will have a neurologic exam to check their reflexes, strength, balance, eyes, and coordination. They will complete questionnaires about their daily life. They will have a lumbar puncture to collect fluid from the area around the spinal cord.
Acamprosate is a pill taken by mouth. Participants will take 2 pills by mouth 3 times a day with meals for 24 weeks. They will record their doses and any missed doses in a diary.
Baseline tests will be repeated during follow-up clinic visits. These tests may be spread out over 3 days.
During phone visits, participants will talk about how they are doing. They will review their diary with researchers.