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Hyperlipidemia and Statin Therapy in Amyotrophic Lateral Sclerosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01592084
First Posted: May 7, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sharon Halton, The Methodist Hospital System
  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.

Condition
Amyotrophic Lateral Sclerosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sharon Halton, The Methodist Hospital System:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 267
Study Start Date: April 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
lipid lowering therapy
those with lipid lowering therapy those without lipid lowering therapy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

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
United States, Texas
the Methodist Neurological Institute
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Investigators
Study Director: Ericka P Simpson, M.D the Methodist Neurological Institute
  More Information

Responsible Party: Sharon Halton, Research Coordinator, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT01592084     History of Changes
Other Study ID Numbers: IRB(2)0609-0087
First Submitted: April 13, 2012
First Posted: May 7, 2012
Last Update Posted: October 12, 2017
Last Verified: May 2012

Keywords provided by Sharon Halton, The Methodist Hospital System:
lipid lowering therapy
survival
ALSFRS
age
BMI
weight

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Hyperlipidemias
Hyperlipoproteinemias
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