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Acamprosate in C9orf72 Hexanucleotide Repeat Expansion Amyotrophic Lateral Sclerosis (ACALS)

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 89 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Notable Enrollment reopened Eligibility criteria expanded, about 20 words · Site details revised Show 2 more changesShow less
    • Eligibility criteria expanded, about 20 words
    • Site details revised
  2. Minor 4 versions Re-verified since May 1, 2026, no change to tracked fieldsv85-v88
  3. Minor Eligibility criteria shortened, about 10 wordsv84 See this version in full on ClinicalTrials.gov ↗
  4. Minor 2 versions Re-verified since Mar 18, 2026, no change to tracked fieldsv82-v83
  5. Minor Trial status: Recruiting to Active, Not Recruitingv81
Show 41 earlier versionsHide 41 earlier versions
  1. Minor Start date changed from estimate of Feb 9, 2026 to Feb 2, 2026v80
  2. Minor Start date: Feb 3, 2026 to Feb 9, 2026v79
  3. Minor Start date: Feb 2, 2026 to Feb 3, 2026v78
  4. Minor Start date: Feb 1, 2026 to Feb 2, 2026v77
  5. Minor Start date: Jan 29, 2026 to Feb 1, 2026v76
  6. Minor Start date: Jan 28, 2026 to Jan 29, 2026v75
  7. Minor Start date: Jan 27, 2026 to Jan 28, 2026v74
  8. Minor Start date: Jan 26, 2026 to Jan 27, 2026v73
  9. Minor Start date: Jan 22, 2026 to Jan 26, 2026v72
  10. Minor Start date: Jan 21, 2026 to Jan 22, 2026v71
  11. Minor Start date: Jan 20, 2026 to Jan 21, 2026v70
  12. Minor Start date: Jan 19, 2026 to Jan 20, 2026v69
  13. Minor Start date: Jan 18, 2026 to Jan 19, 2026v68
  14. Minor Start date: Jan 15, 2026 to Jan 18, 2026v67
  15. Minor Start date: Jan 14, 2026 to Jan 15, 2026v66
  16. Minor Start date: Jan 13, 2026 to Jan 14, 2026v65
  17. Minor Start date: Jan 12, 2026 to Jan 13, 2026v64
  18. Minor Start date: Jan 11, 2026 to Jan 12, 2026v63
  19. Minor Start date: Jan 8, 2026 to Jan 11, 2026v62
  20. Minor Start date: Jan 6, 2026 to Jan 8, 2026v61
  21. Minor Start date: Jan 5, 2026 to Jan 6, 2026v60
  22. Minor Start date: Jan 4, 2026 to Jan 5, 2026v59
  23. Minor Start date: Jan 1, 2026 to Jan 4, 2026v58
  24. Minor Start date: Dec 30, 2025 to Jan 1, 2026v57
  25. Minor Start date: Dec 29, 2025 to Dec 30, 2025v56
  26. Minor Start date: Dec 28, 2025 to Dec 29, 2025v55
  27. Minor Start date: Dec 25, 2025 to Dec 28, 2025v54
  28. Minor Start date: Dec 24, 2025 to Dec 25, 2025v53
  29. Minor Start date: Dec 23, 2025 to Dec 24, 2025v52
  30. Minor Start date: Dec 22, 2025 to Dec 23, 2025v51
  31. Minor Start date: Dec 21, 2025 to Dec 22, 2025v50
  32. Minor Start date: Dec 18, 2025 to Dec 21, 2025v49
  33. Minor Start date: Dec 16, 2025 to Dec 18, 2025v48
  34. Minor Start date: Dec 15, 2025 to Dec 16, 2025v47
  35. Minor Start date: Dec 14, 2025 to Dec 15, 2025v46
  36. Minor Start date: Dec 11, 2025 to Dec 14, 2025v45
  37. Minor Start date: Dec 10, 2025 to Dec 11, 2025v44
  38. Minor Start date: Dec 9, 2025 to Dec 10, 2025v43
  39. Minor Start date: Dec 8, 2025 to Dec 9, 2025v42
  40. Minor Start date: Dec 7, 2025 to Dec 8, 2025v41
  41. Minor Start 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.
Trial Details
NCT Number NCT07204977
Lead Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Amyotrophic Lateral Sclerosis, Motor Neuron Disease
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov