Exploratory Biomarker Study of Cerebrospinal Fluid in Healthy Volunteers

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01126567
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Duration (Months): 2
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Sampling Rate

Study Design

• Study Type: Observational
• Actual Enrollment: 8 participants
• 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
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Multiple Exploratory Biomarkers [Day 1 (at 0, 1, 4, 8, 12, 18, and 24 hours)]

2. Multiple Exploratory Biomarkers [Day 1 (at 0, 1.2.3.4.5.6.7.8.9.10,12,14,16,18,20,22,and 24 hours)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1		Glendale	California	United States	91206

Sponsors and Collaborators

• Abbott

Investigators

• Study Director: Robert Lenz, M.D., Ph.D., Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01126567
• Other Study ID Numbers: F09-113
• First Posted: May 19, 2010
• Last Update Posted: May 19, 2010
• Last Verified: May 1, 2010

• Keywords provided by , ,: Phase 1 Clinical Trials, Cerebrospinal Fluid, Biomarker

Study Results

No Results Posted as of May 19, 2010