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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00983983 |
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Date of registration:
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23/09/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis
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Scientific title:
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Phase II Safety and Tolerability Study of High Fat/High Calorie Versus High Calorie Versus Optimal Nutrition in Subjects With Amyotrophic Lateral Sclerosis |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00983983 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Anne-Marie A Wills, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Clinical diagnosis of ALS
2. Male or female subjects aged 18 years or older
3. Must already be tolerating tube feedings through either a gastrostomy tube (G-tube or
PEG) or jejunostomy tube (J-tube)
4. Must require non-invasive ventilation (BIPAP) for less than 10 hours/day
5. Women of childbearing potential must have a negative pregnancy test at screening and
be non-lactating.
Exclusion Criteria:
1. History of hepatitis including non-alcoholic steatohepatitis (NASH), cholecystectomy,
prior biliary disease such as gallstones
2. History of diabetes
3. History of prior myocardial infarction or stroke
4. Laboratory values: Screening alanine aminotransferase (ALT) or aspartate
aminotransferase (AST) greater than 2.0 times the upper limit of normal or total
bilirubin greater than 1.5 times the upper limit of normal
5. Allergy to soy, fish, or milk products
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Dietary Supplement: Jevity 1.0
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Dietary Supplement: Oxepa
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Dietary Supplement: Jevity 1.5
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Primary Outcome(s)
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Serious Adverse Events
[Time Frame: 5 months]
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Safety Outcomes: Frequency of Adverse Events
[Time Frame: 5 months]
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Tolerability
[Time Frame: 5 months]
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Secondary Outcome(s)
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Biomarkers of Body Composition and Lipid Metabolism
[Time Frame: 5 months follow-up]
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Rate of Change in ALSFRS-R in Units/Month
[Time Frame: Over 5 months]
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Secondary ID(s)
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MDA136152
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2009-P-001132
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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