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Non-invasive ventilation

Phase 2

Amyotrophic Lateral Sclerosis (ALS) | Unknown | Neurology |United Therapeutics Corporation|Last Updated: Jun 16, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLEDDMC
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

Non-invasive ventilation · 1 trial · 10 indications

Phase 2 1
NCT07071935A Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS)Amyotrophic Lateral Sclerosis (ALS)
RECRUITING48 Analytics
PHASE2RECRUITING
A Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS)
Amyotrophic Lateral Sclerosis (ALS)
NCT0707193548
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Study Endpoints

Primary Endpoints

Time to first use of non-invasive ventilation
From enrollment to end of follow-up at approximately 1 year

Number of days between randomization to first recorded overnight usage of non-invasive ventilation according to ventilation device data download.

Secondary Endpoints

Quality of life questionnaire
From enrollment to completion of follow-up at approximately 1 year
Transcutaneous carbon dioxide
From enrollment to end of follow-up at approximately 1 year
Oxygen saturation using pulse oximetry
From enrollment to completion of follow-up at approximately 1 year
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Early Non-invasive VentilationEXPERIMENTALParticipants randomized to this arm will be assigned to start therapy with non-invasive ventilation.
Usual careNO_INTERVENTIONParticipants randomized to this arm will receive usual care for amyotrophic lateral sclerosis.

Interventions

NameTypeDescription
Non-invasive ventilationDEVICENon-invasive ventilation will be started earlier than usual respiratory care guidelines for ALS in the United States.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion 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 Exclusion Criteria: 1. Current or prior or recommended/prescribed use ...

Countries:United States
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Frequently asked questions about Non-invasive ventilation

What is Non-invasive ventilation used for in Amyotrophic Lateral Sclerosis (ALS)?

Non-invasive ventilation is being studied for use in Amyotrophic Lateral Sclerosis (ALS) to address respiratory insufficiency and chronic respiratory failure. The therapy is delivered as positive pressure ventilation support. It is currently in Phase 2 clinical development as an early ventilation intervention for ALS patients.

Who makes Non-invasive ventilation?

United Therapeutics Corporation (NASDAQ: UTHR) is developing Non-invasive ventilation for Amyotrophic Lateral Sclerosis (ALS). The company is conducting a Phase 2 clinical trial of this early ventilation approach in patients with ALS and respiratory insufficiency.

What phase is Non-invasive ventilation in?

Non-invasive ventilation is in Phase 2 clinical development for Amyotrophic Lateral Sclerosis (ALS). It is an investigational therapy and has not been approved by the FDA. The ongoing Phase 2 trial is currently recruiting participants in the United States.

What clinical trials is Non-invasive ventilation in?

Non-invasive ventilation is being evaluated in the EVENT ALS trial (NCT07071935), a Phase 2 study titled 'A Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis'. This randomized, no-treatment controlled trial plans to enroll 48 participants with ALS and respiratory insufficiency in the United States.

What does the Non-invasive ventilation trial for ALS involve?

The EVENT ALS trial (NCT07071935) is a Phase 2, randomized, no-treatment controlled study of early Non-invasive ventilation in Amyotrophic Lateral Sclerosis. It is recruiting 48 adults aged 18 years and older with ALS and respiratory insufficiency. The trial is open-label and not double-blinded, and is being conducted in the United States.