CClinicalTrials.gg
CompletedNCT01592084Updated May 7, 2012

Hyperlipidemia and Statin Therapy in Amyotrophic Lateral Sclerosis

An observational study in Amyotrophic Lateral Sclerosis, sponsored by The Methodist Hospital Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-07.

Sponsored by The Methodist Hospital Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
267
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Amyotrophic Lateral Sclerosis

Keywords

  • lipid lowering therapy
  • survival
  • ALSFRS
  • age
  • BMI
  • weight
03

In context

Motor Neuron Disease

717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.

This study's enrollment of 267 is above the median of 109 across 217 observational studies indexed under Motor Neuron Disease.

Browse Motor Neuron Disease studies →

Lead sponsor

The Methodist Hospital Research Institute is the lead sponsor of 157 studies on the registry; 60 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 15 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

the Methodist Neurological Institute

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
267 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • lipid lowering therapy

    those with lipid lowering therapy those without lipid lowering therapy

06

What researchers measure

Primary outcomes

  1. survial(tracheostomy free,<23 hours on NIPPV, from enrollment)

    Death was confirmed from Social Security Death Index or newspaper obituaries. Tracheostomy- ventilation was also considered as an end of the life time point.

    Time frame: 3years

Secondary outcomes

  1. ALSFRS(measure of disability)

    DeltaFS = (48-ALSFRS at first evaluation )/duration from onset to diagnosis (month) changeFS=(ALSFRS at six months-ALSFRS at first evaluation)/6

    Time frame: at first evaluation(time 0-T0) to six months (T6)

07

Study locations

1 site
  • the Methodist Neurological Institute
    Houston, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01592084
Lead sponsor
The Methodist Hospital Research Institute
Responsible party
Sharon Halton (Research Coordinator, The Methodist Hospital Research Institute) — Principal investigator
First posted
May 7, 2012
Start date
Apr 2008
Primary completion
Sep 2011
Completion
Sep 2011
Last update
May 7, 2012

Study contacts

Ericka P Simpson, M.D
study director · the Methodist Neurological Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion