Hyperlipidemia and Statin Therapy in Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01592084
• Other study ID #: IRB(2)0609-0087
• Status: Completed
• Phase: N/A
• First received: April 13, 2012
• Last updated: May 3, 2012
• Start date: April 2008
• Est. completion date: September 2011

Study information

• Verified date: May 2012
• Source: The Methodist Hospital System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Hyperlipidemias
• Hyperlipoproteinemias
• Motor Neuron Disease
• Sclerosis

Locations

Country	Name	City	State
United States	the Methodist Neurological Institute	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3years
Secondary	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	at first evaluation(time 0-T0) to six months (T6)