Neuropathic PainPhase 2NCT00850005
Intravenous Immunoglobulin (IVIG) for Resistant Neuropathic Pain
A Phase 2 study testing Intravenous immunoglobulin and Normal Saline in people with Neuropathic Pain, run by University of Calgary at 1 site in Canada.
Trial summary
This project addresses a vexing problem that has alluded the best efforts of the medical/scientific community: treatment of resistant neuropathic pain. Neuropathic pain is common and includes conditions such as diabetic neuropathy, post herpetic neuralgia and post stroke pain and is believed to affect at least 3% of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Intravenous immunoglobulin and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years; Clinical diagnosis of treatment-resistant neuropathic pain;
- Score of 4/10 or greater on the DN4 NeP screening questionnaire;
- Bedside examination confirming symptoms of neuropathic pain;
- Moderate to severe pain;
- Completed adequate analgesic trials according to neuropathic pain clinical practice guidelines;
- provides informed consent
Who cannot join
- Pregnant or lactating women;
- Clinical diagnosis of phantom limb pain;
- History of psychosis;
- current, substance dependency disorder;
- presence of clinically significant cardiac or pulmonary disorder that would compromise participants' safety;
- severe pain disorder other than the chronic NeP under study;
- Abnormalities above 1.5 times upper range of normal on screening CBC, blood chemistry;
- Serum IgA less than <0.05 g/L
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta
Alexander J Clark, MD, 403 943 9917
Patricia Muehler, 403 943 9917
About this study
Official title: IVIG for Treatment of Resistant Neuropathic Pain: a Preliminary Study
This project addresses a vexing problem that has alluded the best efforts of the medical/scientific community: treatment of resistant neuropathic pain. Neuropathic pain is common and includes conditions such as diabetic neuropathy, post herpetic neuralgia and post stroke pain and is believed to affect at least 3% of adults. Surveys of patients with neuropathic pain indicate that 60% do not receive adequate relief with current treatment. Results from recent laboratory and human studies reveal a new approach to treatment. This approach is based on the findings that neuroinflammation appears to be involved in development and maintenance of neuropathic pain. This study explores the effects of an immune-modulating blood-derived product, intravenous immunoglobulin (IVIG), in treating neuropathic pain. IVIG is thought to reduce neuroinflammation contributing to neuropathic pain. If successful, the study will provide important insights into pain mechanisms and a better understanding of how IVIG relieves neuropathic pain.
Hypotheses:
- Reduction in neuroinflammation (NI) markers will co-vary with clinical indicators of pain relief
- Patients with higher levels of markers of NI will be more likely to respond to IVIG
Read the detailed description
This study will employ a randomized double blind cross-over design. A total of 12 subjects will be recruited for the study. Once each subject has satisfied the inclusion and exclusion criteria and provided informed consent, the subject will be randomized to either the IVIG or placebo treatment groups, using a pre-determined randomization list generated by the research office at the University of Calgary. Complete responders will begin a monitoring phase, partial and non-responders will return for a second cycle in one month. Complete responders, with prolonged relief, will cross-over to the alternative treatment when their pain returns if this occurs within 6 months of the infusion.
- Conditions
- Neuropathic Pain
- Being tested
- Intravenous immunoglobulin, Normal Saline
- Keywords
- neuropathic pain, resistant, neuroinflammation, neuroinflammatory markers, Neuropathic pain that has not responded to standard therapy
- Medical subject headings
- Neuralgia, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous immunoglobulinBiological
2 g/kg divided over five days
Normal SalineBiological
Same volume as experimental arm
| Study group | Role | What they receive |
|---|---|---|
| IVIG | Experimental | Active treatment will be intravenous immunoglobulin G (Gamunex, immune globulin intravenous [human], 10%), at a dose of 2 g/kg divided over five days (0.4 g/kg/day). Receives: Biological: Intravenous immunoglobulin |
| Placebo | Placebo comparator | The placebo treatment will be intravenous normal saline and will be infused in a similar manner. Receives: Biological: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will consist of change in mean daily pain diary score from baseline to each week post-treatment
Measured: Performed at screening, before the initial infusion, 2 weeks and 4 weeks post treatment
Secondary outcomes (1)
Measurement of neuroinflammation (NI) markers (IL-1β, IL-6, IL-8, TNF-α, MMP-9, TIMP-1)
Measured: Performed at screening, before the initial infusion, 2 weeks and 4 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Investigators
- Alexander J Clark, MD, FRCPC, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850005
- Sponsor's protocol ID
- 200434
- Status last verified
- Feb 2009
- First submitted
- 18 Feb 2009
- Last updated
- 24 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVIG for Treatment of Resistant Neuropathic Pain: a Preliminary Study
- ClinicalTrials.gov ID
- NCT00850005
- Acronym / sponsor ID
- 200434
- Conditions
- Neuropathic Pain
- Keywords
- neuropathic pain, resistant, neuroinflammation, neuroinflammatory markers, Neuropathic pain that has not responded to standard therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 24 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project addresses a vexing problem that has alluded the best efforts of the medical/scientific community: treatment of resistant neuropathic pain. Neuropathic pain is common and includes conditions such as diabetic neuropathy, post herpetic neuralgia and post stroke pain and is believed to affect at least 3% of adults. Surveys of patients with neuropathic pain indicate that 60% do not receive adequate relief with current treatment. Results from recent laboratory and human studies reveal a new approach to treatment. This approach is based on the findings that neuroinflammation appears to be involved in development and maintenance of neuropathic pain. This study explores the effects of an immune-modulating blood-derived product, intravenous immunoglobulin (IVIG), in treating neuropathic pain. IVIG is thought to reduce neuroinflammation contributing to neuropathic pain. If successful, the study will provide important insights into pain mechanisms and a better understanding of how IVIG relieves neuropathic pain.
Hypotheses:
- Reduction in neuroinflammation (NI) markers will co-vary with clinical indicators of pain relief
- Patients with higher levels of markers of NI will be more likely to respond to IVIG
Detailed description
This study will employ a randomized double blind cross-over design. A total of 12 subjects will be recruited for the study. Once each subject has satisfied the inclusion and exclusion criteria and provided informed consent, the subject will be randomized to either the IVIG or placebo treatment groups, using a pre-determined randomization list generated by the research office at the University of Calgary. Complete responders will begin a monitoring phase, partial and non-responders will return for a second cycle in one month. Complete responders, with prolonged relief, will cross-over to the alternative treatment when their pain returns if this occurs within 6 months of the infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVIG | Experimental | Biological: Intravenous immunoglobulinActive treatment will be intravenous immunoglobulin G (Gamunex, immune globulin intravenous [human], 10%), at a dose of 2 g/kg divided over five days (0.4 g/kg/day). |
| Placebo | Placebo comparator | Biological: Normal SalineThe placebo treatment will be intravenous normal saline and will be infused in a similar manner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18 years; Clinical diagnosis of treatment-resistant neuropathic pain;
- Score of 4/10 or greater on the DN4 NeP screening questionnaire;
- Bedside examination confirming symptoms of neuropathic pain;
- Moderate to severe pain;
- Completed adequate analgesic trials according to neuropathic pain clinical practice guidelines;
Key exclusion criteria (8 listed)
- Pregnant or lactating women;
- Clinical diagnosis of phantom limb pain;
- History of psychosis;
- current, substance dependency disorder;
- presence of clinically significant cardiac or pulmonary disorder that would compromise participants' safety;
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 |
|---|---|---|
| Intravenous immunoglobulin2 g/kg divided over five days | Biological | IVIG |
| Normal SalineSame volume as experimental arm | Biological | Placebo |
Primary outcome
The primary outcome measure will consist of change in mean daily pain diary score from baseline to each week post-treatment
Time frame: Performed at screening, before the initial infusion, 2 weeks and 4 weeks post treatment
1 secondary outcome
Measurement of neuroinflammation (NI) markers (IL-1β, IL-6, IL-8, TNF-α, MMP-9, TIMP-1)
Time frame: Performed at screening, before the initial infusion, 2 weeks and 4 weeks post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2009.
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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.
Alexander J Clark, MD, FRCPC principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous immunoglobulin and Normal Saline in people with Neuropathic Pain, run by University of Calgary at 1 site in Canada.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 24 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander J Clark, MD, FRCPC (403 943 9917, john.clark@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure will consist of change in mean daily pain diary score from baseline to each week post-treatment (time frame: Performed at screening, before the initial infusion, 2 weeks and 4 weeks post treatment). 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 24 Feb 2009.