Status:
COMPLETED
Early Treatment of Amyotrophic Lateral Sclerosis (ALS) With Nutrition and Non-Invasive Positive Pressure Ventilation
Lead Sponsor:
Edward Kasaraskis
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 wit...
Detailed Description
Studies to date indicate that percutaneous endoscopic gastrostomy (PEG)-insertion of a feeding tube in the stomach-and non-invasive positive pressure ventilation (NIPPV)-mechanically assisted or gener...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00116558
Start Date
August 1 2004
End Date
January 1 2012
Last Update
July 31 2019
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado
Denver, Colorado, United States, 80262
2
University of Miami
Miami, Florida, United States, 33136
3
University of Kentucky
Lexington, Kentucky, United States, 40536
4
Henry Ford Hospital
Detroit, Michigan, United States, 48202