PainPhase 2NCT00349921
Clonidine Versus Adenosine to Treat Neuropathic Pain
A Phase 2 study testing clonidine and adenosine in people with Pain, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain
- What is being tested?
- clonidine and adenosine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2004to Jan 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with complex regional pain syndrome (CRPS), type I involving a lower extremity
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Center for Clinical Research, 145 Kimel Park Drive
Winston-Salem, North Carolina, 27103
Wake Forest University School of Medicine, Medical Center Boulevard
Winston-Salem, North Carolina, 27157-1009
About this study
The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain.
Read the 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.
- Conditions
- Pain
- Being tested
- clonidine, adenosine, placebo
- Keywords
- pain, chronic pain, clonidine, adenosine, complex regional pain syndrome, CRPS, a2-adrenergic agonists, alpha2-adrenergic agonists
- Medical subject headings
- Pain, Chronic Pain, Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clonidineDrug
Also called duraclon
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.
adenosineDrug
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.
placeboDrug
Also called dummy
inactive substance
placeboDrug
Also called dummy
inactive substance
| Study group | Role | What they receive |
|---|---|---|
| clonidine first, then adenosine | Active comparator | clonidine given in first injection adenosine given in second injection Receives: Drug: clonidine |
| adenosine first, then clonidine | Active comparator | adenosine given in first injection clonidine given in second injection Receives: Drug: adenosine |
| clonidine given first, then placebo | Placebo comparator | placebo Receives: Drug: placebo |
| adenosine given first, then placebo | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Meeting Success Criterion
Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection
Measured: baseline and 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startAug 2004
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James C. Eisenach, M.D., Principal investigator, Wake Forest University Health SciencesRichard Rauck, M.D., Principal investigator, The Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349921
- Sponsor's protocol ID
- P01NS041386_TRIAL1
- Other IDs
- P01NS041386
- Status last verified
- Aug 2018
- First submitted
- 5 Jul 2006
- Last updated
- 10 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clonidine Versus Adenosine to Treat Neuropathic Pain
- ClinicalTrials.gov ID
- NCT00349921
- Acronym / sponsor ID
- P01NS041386_TRIAL1
- Conditions
- Pain
- Keywords
- pain, chronic pain, clonidine, adenosine, complex regional pain syndrome, CRPS, a2-adrenergic agonists, alpha2-adrenergic agonists
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Aug 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 10 Jul 2006 (estimated)
- Results
- Posted 26 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| clonidine first, then adenosine | Active comparator | Drug: clonidineclonidine given in first injection adenosine given in second injection |
| adenosine first, then clonidine | Active comparator | Drug: adenosineadenosine given in first injection clonidine given in second injection |
| clonidine given first, then placebo | Placebo comparator | Drug: placeboplacebo |
| adenosine given first, then placebo | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with complex regional pain syndrome (CRPS), type I involving a lower extremity
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clonidineAlso: duraclonClonidine-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. | Drug | clonidine first, then adenosine |
| adenosineAdenosine-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. | Drug | adenosine first, then clonidine |
| placeboAlso: dummyinactive substance | Drug | clonidine given first, then placebo |
| placeboAlso: dummyinactive substance | Drug | adenosine given first, then placebo |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James C. Eisenach, M.D. principal investigator
Wake Forest University Health Sciences
Richard Rauck, M.D. principal investigator
The Center for Clinical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing clonidine and adenosine in people with Pain, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number Meeting Success Criterion (time frame: baseline and 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018; AzTrials last refreshed its copy on 8 Nov 2026.