Early Treatment of Amyotrophic Lateral Sclerosis (ALS) With Nutrition and Non-Invasive Positive Pressure Ventilation

Completed · Not applicable

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

The purposes of the study are to determine the energy balance and evaluate the nutritional status of patients with ALS, and to investigate the use of NIPPV as respiratory support to treat patients with ALS.

Key facts

Study ID

NCT00116558

Run by

Edward Kasaraskis

People needed

153

Starts

2004-08-01

Expected to finish

2012-01-01

Last updated by the study team

2019-07-31

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to give informed consent.
• If women of childbearing age, must be non-lactating and surgically sterile or using an effective method of birth control (double-barrier or oral contraception) and have a negative pregnancy test.
• Minorities: All races and ethnic backgrounds.
• Disease inclusion: Clinically possible/definite/probable, or laboratory supported probable, sporadic or familial ALS according to the revised Escorial criteria.
• Onset of progressive weakness within 60 months prior to study.
• Willing to return for visits as scheduled and adhere to protocol requirements.
• FVC Criteria
• NIPPV Arm: Best-sitting FVC between 50% and 95% of predicted normal.
• Nutrition Arm: Best-sitting FVC >50% of predicted normal.

You may not qualify if…

• Untreated or unstable hyper or hypothyroidism, untreated or unstable asthma, unstable angina, advanced liver or renal disease, advanced cancer, untreated diabetes or chronic obstructive pulmonary disease (COPD).
• Diagnosis of other motor neuron or other neurological disorder that mimics ALS.
• Diagnosis of other neurodegenerative disease (i.e., Parkinson's disease, Alzheimer's disease, etc.)
• Inflammatory bowel disease or malabsorption syndrome.
• Use of NIPPV, mechanical ventilation, or tracheostomy at the time of consent.
• Inability to adhere to study visit schedule or lack of reliable caretaker if participant requires one.
• Pregnant or lactating woman.

Where it is running

• University of Colorado — Denver, Colorado, United States
• University of Miami — Miami, Florida, United States
• University of Kentucky — Lexington, Kentucky, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Beth Israel — New York, New York, United States
• Columbia University — New York, New York, United States
• SUNY — Syracuse, New York, United States
• Pennsylvania State University — Hershey, Pennsylvania, United States
• Drexel University — Philadelphia, Pennsylvania, United States
• University of Texas-San Antonio — San Antonio, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• University of Vermont — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.