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NCT07204977 · ClinicalTrials.gov registry record · Phase 1
Acamprosate in C9orf72 Hexanucleotide Repeat Expansion Amyotrophic Lateral Sclerosis (ACALS)
A Phase 1 study of Amyotrophic Lateral Sclerosis and Motor Neuron Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT07204977: Active Phase 1 study of Amyotrophic Lateral Sclerosis and Motor Neuron Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT07204977 is a Phase 1 study of Amyotrophic Lateral Sclerosis and Motor Neuron Disease that is active but no longer recruiting, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 30 participants, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07204977, a Phase 1 study of Amyotrophic Lateral Sclerosis and Motor Neuron Disease, is active but no longer recruiting, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Incidence of adverse events and serious adverse events and abnormalities in laboratory tests (complete blood count, acute care panel, hepatic and mineral panel).
Conditions Studied
Interventions
- DRUG Acamprosate calcium
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-02-02 |
| Est. Completion | 2028-09-30 |
| Phase | Phase 1 |
What the registry record for NCT07204977 still lists
NCT07204977 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Acamprosate calcium is the first listed.
NCT07204977 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT07204977 about?
NCT07204977 is a clinical study titled "Acamprosate in C9orf72 Hexanucleotide Repeat Expansion Amyotrophic Lateral Sclerosis (ACALS)". 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 tre...
What is the current status of trial NCT07204977?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-02-02. Estimated completion is 2028-09-30.
What conditions does trial NCT07204977 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis, Motor Neuron Disease.
What interventions are being tested in trial NCT07204977?
The interventions under investigation include: Acamprosate calcium (DRUG).
Who is sponsoring clinical trial NCT07204977?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07204977 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07204977's enrollment target sits among peer trials
30 64th of 102 higher than 38 of 102 other Amyotrophic Lateral Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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