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Exploratory Biomarker Study of Cerebrospinal Fluid in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01126567
First received: February 24, 2010
Last updated: May 18, 2010
Last verified: May 2010
History of Changes
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126567

Locations
United States, California
Glendale, California, United States, 91206
Sponsors and Collaborators
Abbott
Investigators
Study Director: Robert Lenz, M.D., Ph.D. Abbott
  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 May 23, 2013