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Clonidine Versus Adenosine to Treat Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT00349921
Recruitment Status : Completed
First Posted : July 10, 2006
Results First Posted : February 26, 2014
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

Brief Summary:
The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain.

Condition or disease Intervention/treatment Phase
Pain Drug: clonidine Drug: adenosine Drug: placebo Phase 2

Detailed Description:

This study is part of a pain center grant that focuses on how pain, especially chronic neuropathic pain, alters the response to traditional and non-traditional analgesics (pain medications).

Clonidine—a drug commonly used to treat high blood pressure—has been shown to effectively treat neuropathic pain, is FDA-approved for administration via epidural (an injection given in the lower back), and is the third most commonly prescribed drug for chronic intrathecal (an injection into the cerebrospinal fluid) use in people with chronic pain.

Adenosine—a drug commonly administered intravenously (into a vein) to treat certain types of abnormal heart rhythms—has been found to reduce areas of allodynia (pain caused by a stimulus that does not normally cause pain) after intrathecal, but not intravenous administration in people with neuropathic pain.

Intrathecal clonidine relieves pain by actions on a2-adrenoceptors in the spinal cord, whereas adenosine relieves pain by actions on A1 adenosine receptors. Researchers believe that intrathecal adenosine and clonidine may prove to be excellent painkillers for nerve pain. Therefore, the goal of this study is to determine the effects of clonidine and adenosine on nerve pain.

After initial screening, baseline measurements, and training to learn to estimate pain accurately using thermal heat testing, a sample of spinal fluid will be taken from each participant. Participants then will be randomly chosen to receive either clonidine, adenosine, or placebo. After receiving the study medication, participants will be monitored, with their vital signs checked at 30, 60, 120, 180, and 240 minutes.

Duration of the study for participants is 2 weeks, and includes two visits to the research center, each lasting approximately 6 hours.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clonidine Versus Adenosine to Treat Neuropathic Pain
Study Start Date : August 2004
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008


Arm Intervention/treatment
Active Comparator: clonidine first, then adenosine
clonidine given in first injection adenosine given in second injection
Drug: clonidine
Clonidine—a drug commonly used to treat high blood pressure—has been shown to effectively treat neuropathic pain, is FDA-approved for administration via epidural (an injection given in the lower back), and is the third most commonly prescribed drug for chronic intrathecal (an injection into the cerebrospinal fluid) use in people with chronic pain.
Other Name: duraclon

Active Comparator: adenosine first, then clonidine
adenosine given in first injection clonidine given in second injection
Drug: adenosine
Adenosine—a drug commonly administered intravenously (into a vein) to treat certain types of abnormal heart rhythms—has been found to reduce areas of allodynia (pain caused by a stimulus that does not normally cause pain) after intrathecal, but not intravenous administration in people with neuropathic pain.

Placebo Comparator: clonidine given first, then placebo
placebo
Drug: placebo
inactive substance
Other Name: dummy

Placebo Comparator: adenosine given first, then placebo
placebo
Drug: placebo
inactive substance
Other Name: dummy




Primary Outcome Measures :
  1. Number Meeting Success Criterion [ Time Frame: baseline and 2 hours ]
    Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with complex regional pain syndrome (CRPS), type I involving a lower extremity

Exclusion Criteria:

  • Pregnancy
  • Allergy to clonidine
  • Currently taking clonidine or other direct a2-adrenergic agonists, or taking cholinesterase inhibitors
  • Patients with any serious or unstable medical problems (heart, lung, liver, kidney, or nervous system disease)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349921


Locations
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United States, North Carolina
The Center for Clinical Research, 145 Kimel Park Drive
Winston-Salem, North Carolina, United States, 27103
Wake Forest University School of Medicine, Medical Center Boulevard
Winston-Salem, North Carolina, United States, 27157-1009
Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: James C. Eisenach, M.D. Wake Forest University Health Sciences
Principal Investigator: Richard Rauck, M.D. The Center for Clinical Research

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00349921     History of Changes
Other Study ID Numbers: P01NS041386_TRIAL1
P01NS041386 ( U.S. NIH Grant/Contract )
First Posted: July 10, 2006    Key Record Dates
Results First Posted: February 26, 2014
Last Update Posted: September 10, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
pain
chronic pain
clonidine
adenosine
complex regional pain syndrome
CRPS
a2-adrenergic agonists
alpha2-adrenergic agonists
Additional relevant MeSH terms:
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Adenosine
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Clonidine
Adrenergic Agonists
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents