Amyotrophic Lateral SclerosisNCT01592084
Hyperlipidemia and Statin Therapy in Amyotrophic Lateral Sclerosis
An observational study of Amyotrophic Lateral Sclerosis, run by The Methodist Hospital Research Institute at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- How many people
- 267 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the Methodist Neurological Institute
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
the Methodist Neurological Institute
Houston, Texas, 77030
About this study
Official title: 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- lipid lowering therapy, survival, ALSFRS, age, BMI, weight
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| lipid lowering therapy | those with lipid lowering therapy those without lipid lowering therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: at first evaluation(time 0-T0) to six months (T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startApr 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Halton, The Methodist Hospital Research Institute
- Investigators
- Ericka P Simpson, M.D, Study director, the Methodist Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592084
- Sponsor's protocol ID
- IRB(2)0609-0087
- Status last verified
- May 2012
- First submitted
- 13 Apr 2012
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of the Relationship of Hyperlipidemia and Statin Therapy on Survival and Disease Progresssion in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT01592084
- Acronym / sponsor ID
- IRB(2)0609-0087
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- lipid lowering therapy, survival, ALSFRS, age, BMI, weight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 7 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lipid lowering therapy | – | –those with lipid lowering therapy those without lipid lowering therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the Methodist Neurological Institute
Key inclusion criteria (4 listed)
- 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
- Subjects with diagnosis of hyperlipidemia and/or taking lipid lowering medications will not be excluded from study.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
ALSFRS(measure of disability)
Time frame: at first evaluation(time 0-T0) to six months (T6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ericka P Simpson, M.D study director
the Methodist Neurological Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survial(tracheostomy free,<23 hours on NIPPV, from enrollment) (time frame: 3years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2012.