Clonidine Versus Adenosine to Treat Neuropathic Pain

NCT00349921 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: P01NS041386_TRIAL1P01NS041386
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pain

Keywords

pain; chronic pain; clonidine; adenosine; complex regional pain syndrome; CRPS; a2-adrenergic agonists; alpha2-adrenergic agonists

Outcome Measures

Primary Outcomes (1)

• Number Meeting Success Criterion

  Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection

  baseline and 2 hours

Study Arms (4)

clonidine first, then adenosine

ACTIVE COMPARATOR

clonidine given in first injection adenosine given in second injection

Drug: clonidine

adenosine first, then clonidine

ACTIVE COMPARATOR

adenosine given in first injection clonidine given in second injection

Drug: adenosine

clonidine given first, then placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

adenosine given first, then placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

clonidine DRUG

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.

Also known as: duraclon

clonidine first, then adenosine

adenosine DRUG

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.

adenosine first, then clonidine

placebo DRUG

inactive substance

Also known as: dummy

clonidine given first, then placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

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; Complex Regional Pain Syndromes

Interventions

Clonidine; Adenosine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Regina Curry, RN, CCRC
• Organization: Wake Forest University Health Sciences

recurry@wfubmc.edu

(336) 716-4294

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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 10, 2006
• Study Start: August 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: September 10, 2018
• Results First Posted: February 26, 2014

Record last verified: 2018-08

Locations

US (2)