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Hyperlipidemia and Statin Therapy in Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT01592084
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : May 7, 2012
Sponsor:
Information provided by (Responsible Party):
Sharon Halton, The Methodist Hospital Research Institute

Study Description
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Brief 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.

Condition or disease
Amyotrophic Lateral Sclerosis

Study Design
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Study Type : Observational
Actual Enrollment : 267 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohort Study of the Relationship of Hyperlipidemia and Statin Therapy on Survival and Disease Progresssion in Amyotrophic Lateral Sclerosis
Study Start Date : April 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
lipid lowering therapy
those with lipid lowering therapy those without lipid lowering therapy


Outcome Measures
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Primary Outcome Measures :
  1. survial(tracheostomy free,<23 hours on NIPPV, from enrollment) [ Time Frame: 3years ]
    Death was confirmed from Social Security Death Index or newspaper obituaries. Tracheostomy- ventilation was also considered as an end of the life time point.


Secondary Outcome Measures :
  1. ALSFRS(measure of disability) [ Time Frame: at first evaluation(time 0-T0) to six months (T6) ]
    DeltaFS = (48-ALSFRS at first evaluation )/duration from onset to diagnosis (month) changeFS=(ALSFRS at six months-ALSFRS at first evaluation)/6


Biospecimen Retention:   Samples Without DNA
serum

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
the Methodist Neurological Institute
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592084


Locations
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United States, Texas
the Methodist Neurological Institute
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital Research Institute
Investigators
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Study Director: Ericka P Simpson, M.D the Methodist Neurological Institute
More Information
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Responsible Party: Sharon Halton, Research Coordinator, The Methodist Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01592084    
Other Study ID Numbers: IRB(2)0609-0087
First Posted: May 7, 2012    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: May 2012
Keywords provided by Sharon Halton, The Methodist Hospital Research Institute:
lipid lowering therapy
survival
ALSFRS
 age
BMI
weight
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Hyperlipidemias
Hyperlipoproteinemias
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Dyslipidemias
Lipid Metabolism Disorders