HealthyNCT01126567
Exploratory Biomarker Study of Cerebrospinal Fluid in Healthy Volunteers
An observational study of Healthy, run by Abbott at 1 site in United States.
Trial summary
The objective of this study is to determine the effects of cerebrospinal fluid sampling rate on biomarker levels of young, healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sampling Rate
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Feb 2010
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community sample
Who may be able to join
- Age is between 18 and 50 years, inclusive
- Judged to be in general good health based on medical history, physical exam, neuro exam, vital signs, lab profile and ECG
Who cannot join
- Positive urine drug screen for drugs of abuse
- History of bleeding disorder or deep vein thrombosis
- History of migraine or other types of headache more than twice/month, history of spinal disc disease or chronic significant low back pain
- Use of blood thinning compounds within 10 days of lumbar drain placement
- Finding on head CT that contraindicates lumbar puncture
- History of spinal surgery
- Use of tobacco/nicotine containing products within 6 month period prior to initial lumbar drain placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of the Effects of Sampling Rate on Cerebrospinal Fluid (CSF) Biomarker Levels in Healthy Subjects
The objective of this study is to determine the effects of cerebrospinal fluid sampling rate on biomarker levels of young, healthy volunteers.
- Conditions
- Healthy
- Being tested
- Sampling Rate
- Keywords
- Phase 1 Clinical Trials, Cerebrospinal Fluid, Biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling RateOther
Both cohorts will have a lumbar catheter placed and CSF samples will be obtained. The only difference between the two arms will be the sampling rate of CSF. One arm will have a high sampling rate and the other will have a low sampling rate.
| Study group | Role | What they receive |
|---|---|---|
| High Sampling Rate | Samples will be obtained at a high rate Receives: Other: Sampling Rate | |
| Low Sampling Rate | Samples will be obtained at a low rate Receives: Other: Sampling Rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Exploratory Biomarkers
Measured: Day 1 (at 0, 1, 4, 8, 12, 18, and 24 hours)
Multiple Exploratory Biomarkers
Measured: Day 1 (at 0, 1.2.3.4.5.6.7.8.9.10,12,14,16,18,20,22,and 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startDec 2009
- Primary completionJan 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Lenz, M.D., Ph.D., Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126567
- Sponsor's protocol ID
- F09-113
- Status last verified
- May 2010
- First submitted
- 24 Feb 2010
- Last updated
- 19 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effects of Sampling Rate on Cerebrospinal Fluid (CSF) Biomarker Levels in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01126567
- Acronym / sponsor ID
- F09-113
- Conditions
- Healthy
- Keywords
- Phase 1 Clinical Trials, Cerebrospinal Fluid, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 19 May 2010 (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 objective of this study is to determine the effects of cerebrospinal fluid sampling rate on biomarker levels of young, healthy volunteers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Sampling Rate | – | Other: Sampling RateSamples will be obtained at a high rate |
| Low Sampling Rate | – | Other: Sampling RateSamples will be obtained at a low rate |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample
Key inclusion criteria (2 listed)
- Age is between 18 and 50 years, inclusive
- Judged to be in general good health based on medical history, physical exam, neuro exam, vital signs, lab profile and ECG
Key exclusion criteria (7 listed)
- Positive urine drug screen for drugs of abuse
- History of bleeding disorder or deep vein thrombosis
- History of migraine or other types of headache more than twice/month, history of spinal disc disease or chronic significant low back pain
- Use of blood thinning compounds within 10 days of lumbar drain placement
- Finding on head CT that contraindicates lumbar puncture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sampling RateBoth cohorts will have a lumbar catheter placed and CSF samples will be obtained. The only difference between the two arms will be the sampling rate of CSF. One arm will have a high sampling rate and the other will have a low sampling rate. | Other | High Sampling Rate, Low Sampling Rate |
Primary outcome
Multiple Exploratory Biomarkers
Time frame: Day 1 (at 0, 1, 4, 8, 12, 18, and 24 hours)
Multiple Exploratory Biomarkers
Time frame: Day 1 (at 0, 1.2.3.4.5.6.7.8.9.10,12,14,16,18,20,22,and 24 hours)
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 19 May 2010.
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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.
Robert Lenz, M.D., Ph.D. study director
Abbott
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 Healthy, run by Abbott 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 2 inclusion and 7 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 19 May 2010. 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?
Multiple Exploratory Biomarkers (time frame: Day 1 (at 0, 1, 4, 8, 12, 18, and 24 hours)). The study lists 2 primary outcomes in all. 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 19 May 2010.