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Trial record 59 of 325 for:    clonidine

Clonidine-induced Spinal Acetylcholine Release: Normal Volunteers vs. Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT00350532
Recruitment Status : Completed
First Posted : July 10, 2006
Results First Posted : September 23, 2009
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain
Intervention Drug: clonidine
Enrollment 43
Recruitment Details Subjects were recruited from 9/1/2004-6/2/2006. Subjects were recruited from a pain clinic and the control group were healthy subjects.
Pre-assignment Details No significant events or abnormal approaches noted.
Arm/Group Title Neuropathic Pain Subjects Healthy Subjects
Hide Arm/Group Description Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid. Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
Period Title: Overall Study
Started 24 19
Completed 24 19
Not Completed 0 0
Arm/Group Title Neuropathic Pain Subjects Healthy Subjects Total
Hide Arm/Group Description Subjects with existing neuropathic pain Outcome criterion is acetylcholine concentration in cerebrospinal fluid (CSF) at 60 minutes after injection. Healthy subjects with no existing pain conditions. Outcome criterion is acetylcholine concentration in cerebrospinal fluid (CSF) at 60 minutes after injection. Total of all reporting groups
Overall Number of Baseline Participants 24 19 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 19 participants 43 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
 100.0%
19
 100.0%
43
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 19 participants 43 participants
47.875  (11.48) 32  (8.51) 40.86  (12.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 19 participants 43 participants
Female
18
  75.0%
13
  68.4%
31
  72.1%
Male
6
  25.0%
6
  31.6%
12
  27.9%
1.Primary Outcome
Title Acetylcholine Concentration in Cerebrospinal Fluid
Hide Description Acetylcholine levels in CSF after administration of intrathecal clonidine measured by High-performance liquid chromatography (HPLC).
Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
There was no difference noted in acetylcholine levels in healthy subjects compared to subjects with chronic pain
Arm/Group Title Neuropathic Pain Subjects Healthy Subjects
Hide Arm/Group Description:
Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
Overall Number of Participants Analyzed 24 19
Mean (Full Range)
Unit of Measure: picograms per milliliter (pg/ml)
406
(383 to 406)
383
(383 to 406)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Neuropathic Pain Subjects Healthy Subjects
Hide Arm/Group Description Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid. Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
All-Cause Mortality
Neuropathic Pain Subjects Healthy Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Neuropathic Pain Subjects Healthy Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Neuropathic Pain Subjects Healthy Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/19 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. James Eisenach
Organization: Wake Forest University School of Medicine
Phone: 336-716-4498
EMail: jimeisenach@gmail.com
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00350532     History of Changes
Other Study ID Numbers: P01NS041386_TRIAL2
P01NS041386 ( U.S. NIH Grant/Contract )
First Submitted: July 5, 2006
First Posted: July 10, 2006
Results First Submitted: March 23, 2009
Results First Posted: September 23, 2009
Last Update Posted: September 10, 2018