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Completed

NCT Number: NCT01592084

Hyperlipidemia and Statin Therapy 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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Body Weight Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Signs and Symptoms Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

the Methodist Neurological Institute

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 7, 2012
Registry last updated
May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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