Hyperlipidemia and Statin Therapy in Amyotrophic Lateral Sclerosis

Completed

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT01592084
• Lead Sponsor: The Methodist Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2012-04-13
• Status Verified: 2012-05
• Study First Submitted QC: 2012-05-03
• Last Update Submitted: 2012-05-03
• Study First Posted: 2012-05-07
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
survial(tracheostomy free,<23 hours on NIPPV, from enrollment)	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

Name	Time	Method
ALSFRS(measure of disability)	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

Trial Locations

Locations (1)

the Methodist Neurological Institute; 🇺🇸 Houston, Texas, United States