Diaphragm Pacing System (DPS) In Participants With Amyotrophic Lateral Sclerosis (ALS)

Completed · Phase 2

Conditions studied: Amyotrophic Lateral Sclerosis (ALS)

In brief

The study is being conducted to determine if DPS treatment for people with ALS and hypoventilation is associated with improved survival or diaphragm function. The primary objective of the study is to conduct a multi-center, randomized controlled clinical trial comparing standard of care (control) to diaphragm stimulator treatment with the NeuRx® Diaphragm Pacing System™ (DPS) with respect to survival. The secondary objective of the study is to conduct a multi-center, randomized controlled clinical trial to compare standard of care treatment (control) to DPS in ALS subjects with hypoventilation.

Key facts

Study ID

NCT01938495

Run by

Barrow Neurological Institute

People needed

52

Starts

2013-08-01

Expected to finish

2017-04-01

Last updated by the study team

2023-03-09

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 21 years or older.
• Sporadic or familial ALS diagnosed as definite, probable or possible ALS as defined by revised El Escorial criteria.
• Evidence of hypoventilation at Screening with at least one of the following:
• Maximal static inspiratory pressure (MIP) <60 cm H20.
• Upright or supine forced vital capacity (FVC) <50% predicted for gender, age, and height.
• A phrenic nerve potential should be recordable bilaterally.
• Subjects must not have taken riluzole for at least 30 days, or be on a stable dose of riluzole for at least 30 days, prior to randomization (riluzole-naïve subjects are permitted in the study).
• Capable of providing informed consent and following trial procedures.
• Geographically accessible to the site.
• Negative urine pregnancy test at Screening in women of child bearing potential (WOCBP). (Women who are post-menopausal or who have had a hysterectomy are deemed not of child bearing potential).
• Women of child bearing potential must use an adequate form of contraception: abstinence, hormonal contraception (oral contraception, implanted contraception, injected contraception or other hormonal (patch or contraceptive ring, for example) contraception), intrauterine device (IUD) in place for ≥ 3 months, barrier method in conjunction with spermicide, or another adequate method.

You may not qualify if…

• Upright forced vital capacity (FVC) ≤ 45% of predicted for gender, age, and height.
• Any prior use of non-invasive ventilation (NIV) outside of sleep (nighttime or naps).
• Any pulmonary or cardiac disorder or other medical disorder that would be a contraindication for general anesthesia or DPS hardware implantation in the chest.
• Implanted electrical device such as a pacemaker or cardiac defibrillator.
• Known diaphragm abnormality such as hiatal hernia or para-esophageal hernia of abdominal contents into the thoracic cavity.
• Participation in another treatment research study for people with ALS.
• Exposure to any other agent currently under investigation for the treatment of people with ALS (off-label use or investigational) within 30 days of the Screening Visit.
• Clinically significant history of unstable or severe cardiac, oncologic, hepatic, psychiatric, renal disease, or other medically significant illness.
• Pregnant women or women currently breastfeeding.

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• California Pacific Medical Center — San Diego, California, United States
• Stanford University — Stanford, California, United States
• Hospital for Special Care — New Britain, Connecticut, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• University of Florida, Jacksonville — Jacksonville, Florida, United States
• University of Iowa — Iowa City, Iowa, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Henry Ford Health Systems — Detroit, Michigan, United States
• St Louis University — St Louis, Missouri, United States
• Neurology Associates P.C. — Lincoln, Nebraska, United States
• Hospital for Special Surgery — New York, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Carolinas Health Care — Charlotte, North Carolina, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Providence ALS Center — Portland, Oregon, United States
• Drexel University — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Texas Southwestern — Dallas, Texas, United States
• University of Texas — San Antonio, Texas, United States
• University of Vermont — Burlington, Vermont, United States
• Virginia Mason Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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