Study Purpose:
The role of hyperlipidemia and lipid lowering therapy (LLT) in Amyotrophic Lateral Sclerosis (ALS) pathophysiology and its impact on disease progression and survival is unclear. The investigators analyzed the correlation between lipid levels with disease progression and survival in ALS patients and the association of LLT with these outcomes.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Ericka P Simpson, M.D, the Methodist Neurological Institute
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Methodist Neurological Institute
Houston, Texas, 77030 United States
Full Study Summary:
The role of hyperlipidemia and lipid lowering therapy (LLT) in Amyotrophic Lateral Sclerosis (ALS) pathophysiology and its impact on disease progression and survival is unclear. The investigators analyzed the correlation between lipid levels with disease progression and survival in ALS patients and the association of LLT with these outcomes.
Study Sponsor:
The Methodist Hospital Research Institute
Estimated Enrollment:
267
Estimated Study Start Date:
11 / 02 / 2016
Estimated Study Completion Date:
09 / 01 / 2011
Posting Last Modified Date:
05 / 07 / 2012
Date Study Added to neals.org:
05 / 07 / 2012
Minimum Age:
18 Years
Maximum Age:
N/A
Inclusion Criteria:- A clinical diagnosis of laboratory-supported probable, probable, or definite familial, sporadic ALS, according to a modified El Escorial criteria (ref), by the study investigators
- Time from disease onset is less than three years
- 18 years of age
- Subjects with diagnosis of hyperlipidemia and/or taking lipid lowering medications will not be excluded from study.
Exclusion Criteria:
- Requirement for tracheotomy ventilation or non-invasive ventilation for > 23 hours per day
- Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc)
- A clinically significant history of significant medical illness (advanced cancer, chronic inflammatory/infectious conditions, etc) within six months of baseline
- Use of progestins, anabolic steroids, and corticosteroids within 45 days of baseline visit. Therapy is allowed as medically indicated after baseline visit.
the Methodist Neurological Institute
Houston, Texas
77030
United States