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OpenTrials
Completed

NCT Number: NCT01126567

Exploratory Biomarker Study of Cerebrospinal Fluid in Healthy Volunteers

The objective of this study is to determine the effects of cerebrospinal fluid sampling rate on biomarker levels of young, healthy volunteers.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Sampling Rate

Other

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.

Primary outcomes

  1. Multiple Exploratory Biomarkers

    Time frame: Day 1 (at 0, 1, 4, 8, 12, 18, and 24 hours)

  2. 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)

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Study of the Effects of Sampling Rate on Cerebrospinal Fluid (CSF) Biomarker Levels in Healthy Subjects

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 19, 2010
Registry last updated
May 19, 2010

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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