PolyneuropathyPhase 4IMIOXCNCT01302275
Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain
A Phase 4 study testing Oxcarbazepine in people with Polyneuropathy and Peripheral Nerve Injury, run by Søren H. Sindrup at 2 sites in Denmark.
Trial summary
The purpose of this trial is to determine if the effect of oxcarbazepine on chronic peripheral nerve pain depends on the supposed mechanism of the pain, ie. if oxcarbazepine mainly relieve pain in patients with irritable nerves. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyneuropathy, Peripheral Nerve Injury, Postherpetic Neuralgia
- What is being tested?
- Oxcarbazepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 2 sitesDenmark
- Study dates
- Feb 2011to May 2013
- Phase
- Phase 4
- 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 old
- definite or probable neuropathic pain
- diagnosis of polyneuropathy, postherpetic neuralgia or peripheral nerve inju
- pain duration > 3 months
- pain rating at baseline >= 4 point NRS
- Informed consent
Who cannot join
- other non-neuropathic pain condition
- allergy to oxcarbazepine
- renal or hepatic impairment
- epilepsy
- depression and other serious psychiatric disorders
- serious medical condition
Show all 10Show fewer
- previous treatment for neuropathic that cannot be stopped
- pregnancy
- patients expected not to be able to comply with study protocol
- treatment with anticonvulsants, antidepressant or opioids
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Danish Pain Research Center, Aarhus University Hospital
Aarhus, 8000
Department of Neurology, Odense University Hospital
Odense, DK-5000
About this study
Official title: Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain: Predictors of Response - a Randomised, Double-blind, Placebo-controlled Clinical Trial
The purpose of this trial is to determine if the effect of oxcarbazepine on chronic peripheral nerve pain depends on the supposed mechanism of the pain, ie. if oxcarbazepine mainly relieve pain in patients with irritable nerves.
- Being tested
- Oxcarbazepine
- Keywords
- neuropathic pain, oxcarbazepine, pain mechanism
- Medical subject headings
- Polyneuropathies, Peripheral Nerve Injuries, Neuralgia, Postherpetic, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxcarbazepineDrug
Also called Trileptal
Oxcarbazepine capsules 300 mg is gradually increased from 300 mg/day to 2400 mg/day Placebo capsules increase from 1/day to 8/day
| Study group | Role | What they receive |
|---|---|---|
| oxcarbazepine | Experimental | Oxcarbazepine is gradually increased during 21 days from 300 mg x 1 daily to 2400 mg, and kept on that dose ( 2400 mg) for three weeks. Receives: Drug: Oxcarbazepine |
| placebo | Placebo comparator | Not described Receives: Drug: Oxcarbazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pain rated on numeric rating scale
Pain is rated daily on 0-10 point numeric rating scales. From the daily ratings from week 6 of each treatment period a median value is determined and used for data analysis. The analysis will compare scores between treatments (oxcabazepine vs placebo) and treatment effects (placebo-oxcarbazepine) between groups irritable nociceptor vs non-irritable nociceptors and some other subgroups.
Measured: Measurements from week 6 of treatment period
Secondary outcomes (7)
Response defined as at least 50% reduction in pain score
Response defined as 50% reduction in pain score (median value week 6 of treatment period compared to median value during baseline period). Repsonse rates for each treatment and each phenotype will be calculated
Measured: Week 6 of each treatment period vs. baseline
Neuropathic Pain Symptom Inventory
Different pain dimensions as rated by Neuropathic Pain Symptom Inventory
Measured: Week 6 of each treatment period
Patient Global Impression of Change
Measured: Week 6 of each treatment period
Rating of evoked pain
Rating on numeric rating scales of pain induced by stimulation with cold rollers, stiff von Frey hain and dynamic touch with rubber sponge
Measured: Week 6 of each treatment period
Sleep disturbance
Numeric rating scale ratings of pain induced sleep disturbance, median value of ratings from week 6 of each treatment period
Measured: Week 6 of each treatment period
Quality of life
Rating of quality of life with numeric rating scale
Measured: Week 6 of each treatment period
Use of escape medication
Number of paracetamol 500 mg used during the last week of each treamtent period
Measured: Week 6 of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyneuropathyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Søren H. Sindrup
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Pain Research Center, Innovative Medicines Initiative
- Responsible party
- Sponsor-investigator, Søren H. Sindrup, Odense University Hospital
- Investigators
- Søren H Sindrup, MD, Principal investigator, Department of Neurology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302275
- Sponsor's protocol ID
- IMIOXC
- Acronym
- IMIOXC
- Status last verified
- May 2014
- First submitted
- 23 Feb 2011
- Last updated
- 5 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain: Predictors of Response - a Randomised, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01302275
- Acronym / sponsor ID
- IMIOXC / IMIOXC
- Keywords
- neuropathic pain, oxcarbazepine, pain mechanism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Søren H. SindrupUniversity, hospital or other
- Collaborators
- Danish Pain Research Center, Innovative Medicines Initiative
- Study start
- Feb 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Feb 2011 (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.
The purpose of this trial is to determine if the effect of oxcarbazepine on chronic peripheral nerve pain depends on the supposed mechanism of the pain, ie. if oxcarbazepine mainly relieve pain in patients with irritable nerves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxcarbazepine | Experimental | Drug: OxcarbazepineOxcarbazepine is gradually increased during 21 days from 300 mg x 1 daily to 2400 mg, and kept on that dose ( 2400 mg) for three weeks. |
| placebo | Placebo comparator | Drug: Oxcarbazepine |
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 old
- definite or probable neuropathic pain
- diagnosis of polyneuropathy, postherpetic neuralgia or peripheral nerve inju
- pain duration > 3 months
- pain rating at baseline >= 4 point NRS
Key exclusion criteria (10 listed)
- other non-neuropathic pain condition
- allergy to oxcarbazepine
- renal or hepatic impairment
- epilepsy
- depression and other serious psychiatric disorders
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 |
|---|---|---|
| OxcarbazepineAlso: TrileptalOxcarbazepine capsules 300 mg is gradually increased from 300 mg/day to 2400 mg/day Placebo capsules increase from 1/day to 8/day | Drug | oxcarbazepine, placebo |
Primary outcome
Total pain rated on numeric rating scale
Time frame: Measurements from week 6 of treatment period
Pain is rated daily on 0-10 point numeric rating scales. From the daily ratings from week 6 of each treatment period a median value is determined and used for data analysis. The analysis will compare scores between treatments (oxcabazepine vs placebo) and treatment effects (placebo-oxcarbazepine) between groups irritable nociceptor vs non-irritable nociceptors and some other subgroups.
7 secondary outcomes
Response defined as at least 50% reduction in pain score
Time frame: Week 6 of each treatment period vs. baseline
Neuropathic Pain Symptom Inventory
Time frame: Week 6 of each treatment period
Patient Global Impression of Change
Time frame: Week 6 of each treatment period
Rating of evoked pain
Time frame: Week 6 of each treatment period
Sleep disturbance
Time frame: Week 6 of each treatment period
Quality of life
Time frame: Week 6 of each treatment period
Use of escape medication
Time frame: Week 6 of each treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
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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.
Søren H Sindrup, MD principal investigator
Department of Neurology, Odense University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxcarbazepine in people with Polyneuropathy and Peripheral Nerve Injury, run by Søren H. Sindrup at 2 sites in Denmark.
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 10 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 5 May 2014. 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 Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total pain rated on numeric rating scale (time frame: Measurements from week 6 of treatment period). 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 5 May 2014.