Amyotrophic Lateral Sclerosis study: Acamprosate calcium
Official title Acamprosate in C9orf72 Hexanucleotide Repeat Expansion Amyotrophic Lateral Sclerosis (ACALS)
ClinicalTrials.gov ID: NCT07204977
What this study is testing
What is Acamprosate calcium?
an investigational oral tablet being studied as a potential treatment for amyotrophic lateral sclerosis (ALS) in people with a C9orf72 mutation is designed to modulate glutamate signaling in the nervous system
Also referred to as acamprosate.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether acamprosate (a pill) is safe and how well it works in people with ALS who have a C9orf72 gene mutation.
- Who it's for
- You may be able to join if you are 18 or older, have ALS, and have a C9orf72 gene mutation.
- What's involved
- You would take two pills three times a day with meals for 24 weeks. You will have five clinic visits and eight phone check‑ins, plus blood tests, scans, breathing tests, and a spinal fluid tap.
- Time commitment
- The study lasts about 32 weeks with 13 visits: five at the clinic and eight by phone.
- Phase 1: an early, usually small safety study
- Time commitment: about 32 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following
- Aged 18 years or older at the time of the screening visit.
- Able to provide informed consent and comply with study procedures and availability for the duration of the study.
- Diagnosis of ALS (possible, probable, or definite according to the World Federation of Neurology El Escorial revised criteria or the Gold Coast...
- CLIA-certified genetic testing showing a pathogenic hexanucleotide repeat expansion in the C9orf72 gene.
You likely can't join if
- Dependence on daytime mechanical ventilation (invasive or non-invasive, including Continuous Positive Airway Pressure (CPAP) or Bilevel Positive...
- 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.
- 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).
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following
- Aged 18 years or older at the time of the screening visit.
- Able to provide informed consent and comply with study procedures and availability for the duration of the study.
- 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...
- 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...
- Participant must be competent to self-administer the medication as deemed by study team. Alternatively, participant must have a competent caregiver who can and will be responsible for administering the study drug.
- Participant has established care with a neurologist and will maintain this clinical care throughout the study.
- For females of reproductive potential: use of effective or highly effective contraception for at least one month prior to screening and agreement to use such a method during study participation and for an additional 8...
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
- 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).
- Active drug abuse or alcoholism.
- Unstable medical condition that, in the opinion of the investigators, makes participation unsafe.
- Renal impairment estimated glomerular filtration rate \<=60mL/min/1.73m\^2.
- Unstable psychiatric illness defined as psychosis or untreated major depression within 90 days of the screening visit.
- Estimated glomerular filtration rate \<=60mL/min/1.73m\^2.
- Platelet concentration of \<100,000/microl.
- PT and PTT \>1.2 times the upper limit of normal.
- Hemoglobin \<10mg/dL.
- Positive Hepatitis B Surface Antigen and Hepatitis C Virus Antibody
- Participants who are unable to swallow tablets whole, as required by the administration guidelines.
- Participants who are dependent on a gastrostomy tube for medication administration. Since acamprosate is in tablet form that cannot be crushed or altered, it is unsuitable for administration through a gastrostomy tube.
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 32 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.