RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Acamprosate calcium for Amyotrophic Lateral Sclerosis

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.

Official registry: https://clinicaltrials.gov/study/NCT07204977 · National Institute of Neurological Disorders and Stroke (NINDS) · enrollment listed as 30

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Acamprosate calcium. The registry lists allocation as na. Background: Amyotrophic lateral sclerosis (ALS) is a disorder that damages nerve cells in the brain and spinal cord.

They plan to enroll about 30 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Acamprosate calcium

Primary outcome (registry wording): Safety of acamprosate in patients with ALS and mutation in C9orf72.

Who it is for (from inclusion criteria)

Ages 18 Years to 99 Years
In order to be eligible to participate in this study, an individual must meet all of the following who can join:
Aged 18 years or older at the time of the screening visit
Diagnosis of ALS (possible, probable, or definite according to the World Federation of Neurology El Escorial revised criteria or the Gold Coast Criteria) with or without mild cognitive impairment, mild behavioral impairment, or frontotemporal dementia (FTD)
CLIA-certified genetic testing showing a pathogenic hexanucleotide repeat expansion in the C9orf72 gene
Symptom duration less than 2 years, or if greater than 2 years, disease progression at a rate that, in the judgement of the investigator, would allow for completion of the study
If taking riluzole, edaravone, or phenylbutyrate/TUDCA, the participant must be on a stable dose for at least 30 days prior to the screening visit, or have stopped taking riluzole, edaravone, or phenylbutyrate/TUDCA at least 30 days prior to the baseline visit
Participant has established care with a neurologist and will maintain this clinical care throughout the study

Who the registry excludes

An individual who meets any of the following criteria will be excluded from participation in this study:
Dependence on daytime mechanical ventilation (invasive or non-invasive, including Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) at the time of the screening visit
Participation in any other investigational drug trial or using investigational drug(s) (within 4 weeks prior to the Day 0 visit and thereafter)
Participants must not become pregnant or breastfeed for the duration of the study. Participants of childbearing potential must have a negative pregnancy test at screening and be non-lactating
Men who are trying to become fathers or donate sperm
History of positive test or positive result at screening for HIV
History of severe sulfite allergy (i.e., anaphylaxis)

Public study contact (from the registry)

Carol H Hoffman

(301) 451-1229

carol.hoffman@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

National Institutes of Health Clinical Center — Bethesda, Maryland (recruiting)

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FAQ about this NCT record

Is NCT07204977 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07204977?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07204977?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary