Trial Outcomes & Findings for Clonidine-induced Spinal Acetylcholine Release: Normal Volunteers vs. Neuropathic Pain (NCT NCT00350532)

Results Overview

Acetylcholine levels in CSF after administration of intrathecal clonidine measured by High-performance liquid chromatography (HPLC).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

60 minutes

Results posted on

2018-09-10

Participant Flow

Subjects were recruited from 9/1/2004-6/2/2006. Subjects were recruited from a pain clinic and the control group were healthy subjects.

No significant events or abnormal approaches noted.

Participant milestones

Participant milestones
Measure	Neuropathic Pain Subjects 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 Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid.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.	Healthy Subjects 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 Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid.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 Study STARTED	24	19
Overall Study COMPLETED	24	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neuropathic Pain Subjects n=24 Participants Subjects with existing neuropathic pain Outcome criterion is acetylcholine concentration in cerebrospinal fluid (CSF) at 60 minutes after injection.	Healthy Subjects n=19 Participants Healthy subjects with no existing pain conditions. Outcome criterion is acetylcholine concentration in cerebrospinal fluid (CSF) at 60 minutes after injection.	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants	19 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	47.875 years STANDARD_DEVIATION 11.48 • n=5 Participants	32 years STANDARD_DEVIATION 8.51 • n=7 Participants	40.86 years STANDARD_DEVIATION 12.91 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	13 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes

Population: There was no difference noted in acetylcholine levels in healthy subjects compared to subjects with chronic pain

Acetylcholine levels in CSF after administration of intrathecal clonidine measured by High-performance liquid chromatography (HPLC).

Outcome measures

Outcome measures
Measure	Neuropathic Pain Subjects n=24 Participants 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.	Healthy Subjects n=19 Participants 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.
Acetylcholine Concentration in Cerebrospinal Fluid	406 picograms per milliliter (pg/ml) Interval 383.0 to 406.0	383 picograms per milliliter (pg/ml) Interval 383.0 to 406.0

Adverse Events

Neuropathic Pain Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. James Eisenach

Wake Forest University School of Medicine

Phone: 336-716-4498

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place