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

NCT00350532 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: P01NS041386_TRIAL2P01NS041386
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the amount of acetylcholine release after a single injection of clonidine in normal volunteers and individuals with neuropathic pain.

Conditions

Pain

Keywords

pain, chronic pain; acetylcholine; clonidine; a2-adrenergic agonists; alpha2-adrenergic agonists

Outcome Measures

Primary Outcomes (1)

• Acetylcholine Concentration in Cerebrospinal Fluid

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

  60 minutes

Study Arms (2)

Neuropathic Pain Subjects

ACTIVE COMPARATOR

Chronic Pain 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 Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid.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.

Drug: clonidine

Healthy Subjects

ACTIVE COMPARATOR

Healthy 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 Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid.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.

Drug: clonidine

Interventions

clonidine DRUG

Patients will receive intrathecal clonidine (or clonidine injected into cerebrospinal fluid)

Neuropathic Pain Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult volunteers
• Patients with neuropathic pain

You may not qualify if:

• Pregnancy
• Allergy to clonidine
• Currently taking clonidine or other direct a2-adrenergic agonists
• Taking cholinesterase inhibitors

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

The Center for Clinical Research, 145 Kimel Park Drive

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest University School of Medicine, Medical Center Boulevard

Winston-Salem, North Carolina, 27157-1009, United States

Location

MeSH Terms

Conditions

Pain; Chronic Pain

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. James Eisenach
• Organization: Wake Forest University School of Medicine

jimeisenach@gmail.com

336-716-4498

Study Officials

• James C. Eisenach, M.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Richard Rauck, M.D.

  The Center for Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 10, 2006
• Study Start: September 1, 2004
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: September 10, 2018
• Results First Posted: September 23, 2009

Record last verified: 2018-08

Locations

US (2)