Clinical Trials

Inclusion Criteria:

All

• 18 years or older.

• Capable of providing informed consent.

• Able and willing to follow study procedures in the view of the investigator.

ALS participants (without VTE)

• Confirmed diagnosis of ALS.

• Qualify for non-invasive ventilation (NIV) or be receiving enteral nutrition AND have lower limb weakness impairing independent ambulation (i.e. requiring use of a cane, walker, wheelchair, etc. at least some of the time, though not those who only require ankle-foot-orthotic (AFO) to ambulate)

  • US or European guidelines for NIV may be used; however, if European guidelines are used, the participant must have at least 1 respiratory symptom in addition to an objective measure of respiratory impairment.

ALS participants (with VTE)

• Confirmed diagnosis of ALS

• Qualify for non-invasive ventilation (NIV) or be receiving enteral nutrition AND have lower limb weakness impairing independent ambulation (i.e. requiring use of a cane, walker, wheelchair, etc. at least some of the time, though not those who only require ankle-foot orthotic (AFO) to ambulate)

  • US or European guidelines for NIV may be used; however, if European guidelines are used, the participant must have at least 1 respiratory symptom in addition to an objective measure of respiratory impairment.

• Diagnosis of VTE  at screening or within 2 weeks of screening.

Non-neurologic controls

• Ambulatory

Exclusion Criteria: 

All

• Inability to comply with study procedures in the view of the investigator.

• Unstable medical or psychiatric disease

• Having any of the following comorbid conditions that can be associated with an elevated D-Dimer

  • Active malignancy or cancer (excluding basal cell carcinoma)

  • Active COVID-19 infection, sepsis, or other severe infections

  • myocardial infarction/heart attack, stroke, limb ischemia, intracardiac thrombus, or major surgery within 90 days of enrollment

  • atrial fibrillation

  • liver or kidney disease as determined by the investigator (e.g. Child-Pugh worse than Class A; hemodialysis or GFR <30mL/min)

  • sickle cell disease

  • Vascular malformation

• Pregnancy

ALS participants without VTE and Non-neurologic controls

• Recent (1 month), current, or planned use of anticoagulation therapy.

  • Patients on anti-platelet therapy should also be excluded unless goal enrollment cannot otherwise be achieved

• Symptomatic PE, DVT at enrollment

• Active respiratory disease

Non-neurologic controls

• Presence of a neurologic or medical (i.e. respiratory/pulmonary) diagnosis that may affect study results.

• First degree relative of someone with confirmed genetic ALS

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/11/2025. Questions regarding updates should be directed to the study team contact.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/28/23. Questions regarding updates should be directed to the study team contact.