Exploratory Biomarker Study of Cerebrospinal Fluid in Healthy Volunteers
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01126567
First received: February 24, 2010
Last updated: May 18, 2010
Last verified: May 2010
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Purpose
The objective of this study is to determine the effects of cerebrospinal fluid sampling rate on biomarker levels of young, healthy volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Other: Sampling Rate |
Phase 1 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Study of the Effects of Sampling Rate on Cerebrospinal Fluid (CSF) Biomarker Levels in Healthy Subjects |
Further study details as provided by Abbott:
Primary Outcome Measures:
- Multiple Exploratory Biomarkers [ Time Frame: Day 1 (at 0, 1, 4, 8, 12, 18, and 24 hours) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole blood, plasma, cerebrospinal fluid
| Enrollment: | 8 |
| Study Start Date: | December 2009 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
High Sampling Rate
Samples will be obtained at a high rate
|
Other: Sampling Rate
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.
|
|
Low Sampling Rate
Samples will be obtained at a low rate
|
Other: Sampling Rate
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Community sample
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Daniel LLano, M.D., PhD, Associate Medical Director, Abbott |
| ClinicalTrials.gov Identifier: | NCT01126567 History of Changes |
| Other Study ID Numbers: | F09-113 |
| Study First Received: | February 24, 2010 |
| Last Updated: | May 18, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Abbott:
|
Phase 1 Clinical Trials, Cerebrospinal Fluid, Biomarker |
ClinicalTrials.gov processed this record on October 17, 2012
