Hyperlipidemia and Statin Therapy in Amyotrophic Lateral Sclerosis

May 3, 2012 updated by: Sharon Halton, The Methodist Hospital Research Institute

Cohort Study of the Relationship of Hyperlipidemia and Statin Therapy on Survival and Disease Progresssion in Amyotrophic Lateral Sclerosis

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

267

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • the Methodist Neurological Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

the Methodist Neurological Institute

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
lipid lowering therapy
those with lipid lowering therapy those without lipid lowering therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at first evaluation(time 0-T0) to six months (T6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Methodist Hospital Research Institute

Investigators

  • Study Director: Ericka P Simpson, M.D, the Methodist Neurological Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

April 13, 2012

First Submitted That Met QC Criteria

May 3, 2012

First Posted (Estimate)

May 7, 2012

Study Record Updates

Last Update Posted (Estimate)

May 7, 2012

Last Update Submitted That Met QC Criteria

May 3, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB(2)0609-0087

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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