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High Fat/High Calorie Trial

Quick Info:
Status:
Ongoing, But Not Recruiting
Estimated Enrollment:
30 		Phase:
II
Treatment Type:
Diet Modification 		Trial Type:
Double Blind, Placebo Control
Sponsor:
Massachusetts General Hospital
Primary Investigator:
Anne-Marie A Wills, M.D., Massachusetts General Hospital 		Contact Information:
Enrollment Criteria:
  • Forced Ventilation
    Breathing Ability
    Percent lung function (FVC) or (SVC)
    N/A
  • Months/Onset
    Months Since Onset
    Number of months since first symptoms of ALS
    N/A
  • BiPap Allowed
    Non-Invasive Ventilation (NIV)
    Can PALS use a BiPAP in the trial?
    Maybe
  • DPS Allowed
    Diaphragm Pacer (DPS)
    Can PALS use a DPS in the trial?
    Unknown
Update Notes:
3/27/2013Enrollment criteria added.
1/29/2013Protocol updated.
Locations:
  • Phoenix, AZ, 85013, United States
  • Atlanta, GA, 30322, United States
  • Grand Rapids, MI, 49503, United States
  • Burlington, VT, 05401, United States
  • Irvine, CA, 92868, United States
  • Sarasota, FL, 34239, United States
  • Portland, OR, 97239, United States
  • Philadelphia, PA, 19107, United States
  • San Francisco, CA, 94120, United States
  • Boston, MA, 02114, United States
  • Charlotte, NC, 28207, United States
  • New York, NY, 10032, United States
  • Houston, TX, 77030, United States
Other Information:
Purpose: The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of long-term use of high fat/high calorie and high calorie diets in people with amyotrophic lateral sclerosis (ALS) (Lou Gehrig's disease).
Eligibility: 18 years or older. Both Genders. No heathly volunteers.
Details: Three arm study: high fat/high calorie diet, high calorie diet, placebo control diet.
Collaborator(s):
ALS Forum:
First Published on Clinicaltrials.gov: 9/23/2009
ClinicalTrials.gov ID: NCT00983983
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov   Download PDF