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New treatment option for Amyotrophic Lateral Sclerosis (ALS)
Official title A Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS)
ClinicalTrials.gov ID: NCT07071935
What this study is testing
- What it's testing
- Amyotrophic lateral sclerosis (ALS) is a disease that causes weakness of the muscles of the body. The disease can eventually lead to severe breathing problems, which is the most common cause of death from ALS.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosed with ALS using the Gold Coast Criteria within the last 6 months
- Age ≥18 years
- Willingness and ability to participate in study procedures
- Provision of signed and dated informed consent form
You likely can't join if
- Current or prior or recommended/prescribed use of NIV including: i) bi-level positive pressure ventilation, such as a respiratory assist device or...
- Forced vital capacity \<50% of predicted normal
- Maximal inspiratory pressure \> -60 cmH2O (eg, -50 or -40 cmH2O would be excluded)
- Chronic use of supplemental oxygen at any part of the day
- Enrollment in hospice
- Current tracheostomy
See the full eligibility criteria
- Diagnosed with ALS using the Gold Coast Criteria within the last 6 months
- Age ≥18 years
- Willingness and ability to participate in study procedures
- Provision of signed and dated informed consent form
- Current or prior or recommended/prescribed use of NIV including: i) bi-level positive pressure ventilation, such as a respiratory assist device or home ventilator ii) Current or prior use of continuous positive airway...
- Forced vital capacity \<50% of predicted normal
- Maximal inspiratory pressure \> -60 cmH2O (eg, -50 or -40 cmH2O would be excluded)
- Chronic use of supplemental oxygen at any part of the day
- Enrollment in hospice
- Current tracheostomy
- Prior history of sleep apnea where non-invasive ventilation was used or recommended
- Thoracic, abdominal, facial or ophthalmic surgery in the prior 6 weeks
- Coughing up blood
- Myocardial infarction in the previous 4 weeks
- Absolute contraindication to NIV, which includes lethargy, obtundation, facial fractures, active pneumothorax, and airway obstruction (such as a tumor)
- Presence of cognitive dysfunction that would impair ability to complete study procedures, as determined by neurology attending physician
The study team makes the final eligibility decision.
Where it's taking place
- Hershey, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Philadelphi, Pennsylvania, 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 - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hershey, Pennsylvania, United States; Philadelphia, Pennsylvania, United States; Philadelphi, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.