Hyperlipidemia and Statin Therapy in Amyotrophic Lateral Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sharon Halton, The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT01592084
First received: April 13, 2012
Last updated: May 3, 2012
Last verified: May 2012
  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 The Methodist Hospital System:

Primary Outcome Measures:
  • survial(tracheostomy free,<23 hours on NIPPV, from enrollment) [ Time Frame: 3years ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 13, 2012
Last Updated: May 3, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Hyperlipidemias
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Dyslipidemias
Lipid Metabolism Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014