Neuropathic Pain Caused by Lumbar Radicular PainPhase 4EMONNCT01869907
Effect of Minocycline on Pain Caused by Nerve Damage
A Phase 4 study testing Minocycline and Amitriptyline in people with Neuropathic Pain Caused by Lumbar Radicular Pain, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
The purpose of this study is to determine if minocycline is effective in the treatment of neuropathic pain. The effect of minocycline will be compared to the effect of placebo and amitriptyline. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic Pain Caused by Lumbar Radicular Pain
- What is being tested?
- Minocycline and Amitriptyline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2011to Aug 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lumbar radicular pain due to disc herniation, failed back surgery syndrome or spinal canal stenosis causing neuropathic pain
Who cannot join
- Diabetic, alcoholic or drug induced polyneuropathies
- Depression or psychiatric comorbidity affecting pain sensation.
- Use of antidepressants
- Fibromyalgia and Chronic Fatigue Syndrome
- Pregnancy.
- Previous spinal cord damage
- Malignancies
- Allergy to minocycline or amitriptyline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Minocycline on Neuropathic Pain
The purpose of this study is to determine if minocycline is effective in the treatment of neuropathic pain. The effect of minocycline will be compared to the effect of placebo and amitriptyline.
Read the detailed description
Neuropathic pain is pain caused by damage to the central or peripheral nervous system. To date, therapy consists of tricyclic antidepressants (such as amitriptyline) or anticonvulsants. However, results are disappointing. Minocycline, a FDA-approved second generation tetracycline, was efficacious in various animal models of neuropathic pain. We want to study the effect of minocycline in neuropathic pain in humans. The type of neuropathic pain we want to investigate is lumbar radicular pain since this is the most prevalent condition associated with neuropathic pain in humans.
This placebo-controlled randomized double blind trial consists of 3 arms:
- Placebo, once daily by mouth during 14 days.
- Amitriptyline 25mg, once daily by mouth during 14 days.
- Minocycline 100mg, once daily by mouth during 14 days.
Patients can take rescue medication if necessary: tramadol 50mg by mouths up to 3-times daily.
Brain-derived neurotrophic factor is implicated in the generation and maintenance of neuropathic pain in different animal models of neuropathic pain. To study the role of brain-derived neurotrophic factor in neuropathic pain in humans, we will determine its concentration in serum and plasma before and after 14 days medication intake.
- Being tested
- Minocycline, placebo, Amitriptyline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
100 mg once daily by mouth during 14 days
placeboDrug
once daily by mouth during 14 days
AmitriptylineDrug
25mg once daily by mouth during 14 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo, once daily Receives: Drug: placebo |
| Amitriptyline | Active comparator | Amitriptyline 25mg, once daily Receives: Drug: Amitriptyline |
| Minocycline | Active comparator | Minocycline 100mg, once daily Receives: Drug: Minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be measured using a visual analogue scale and the change in pain intensity between baseline and day 7, day 7 and day 14, baseline and day 14 will be evaluated
Measured: Baseline (before start of study), 7 and 14 days after start of medication intake
Secondary outcomes (2)
neuropathic pain diagnostic questionnaire (DN4) score
The DN4 questionnaire is used to assess the neuropathic symptoms of the pain and the change in DN4 score between baseline and day 7, day 7 and day 14, baseline and day 14 will be evaluated
Measured: Baseline (before start of study), 7 and 14 days after medication intake
Amount of rescue medication taken
Rescue medication consists of tramadol 50mg by mouth 3-times daily if necessary. Patients will be provided with a total of 42 tablets of tramadol 50mg for the duration of the study. The remaining rescue medication will be counted on day 7 and day 14 and the change in rescue medication intake between baseline and day 7, day 7 and day 14, baseline and day 14 will be evaluated
Measured: 7 and 14 days after medication intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startSep 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neuropathic Pain Caused by Lumbar Radicular PainStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pascal Vanelderen, Ziekenhuis Oost-Limburg
- Investigators
- Jan Van Zundert, MD, PhD, Study chair, Ziekenhuis Oost-LimburgMartine Puylaert, MD, Study chair, Ziekenhuis Oost-LimburgPieter De Vooght, MD, Study chair, Ziekenhuis Oost-LimburgRoel Mestrum, MD, Study chair, Ziekenhuis Oost-LimburgRené Heylen, MD, PhD, Study chair, Ziekenhuis Oost-LimburgPascal Vanelderen, MD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869907
- Sponsor's protocol ID
- EMON
- Acronym
- EMON
- Status last verified
- Jan 2015
- First submitted
- 27 May 2013
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vanelderen P, Rouwette T, Kozicz T, Heylen R, Van Zundert J, Roubos EW, Vissers K. Effects of chronic administration of amitriptyline, gabapentin and minocycline on spinal brain-derived neurotrophic factor expression and neuropathic pain behavior in a rat chronic constriction injury model. Reg Anesth Pain Med. 2013 Mar-Apr;38(2):124-30. doi: 10.1097/AAP.0b013e31827d611b.
PubMed 23337936Bastos LF, de Oliveira AC, Watkins LR, Moraes MF, Coelho MM. Tetracyclines and pain. Naunyn Schmiedebergs Arch Pharmacol. 2012 Mar;385(3):225-41. doi: 10.1007/s00210-012-0727-1. Epub 2012 Jan 27.
PubMed 22282331Zhang Q, Peng L, Zhang D. Minocycline may attenuate postherpetic neuralgia. Med Hypotheses. 2009 Nov;73(5):744-5. doi: 10.1016/j.mehy.2009.04.028. Epub 2009 May 24.
PubMed 19467572Sumracki NM, Hutchinson MR, Gentgall M, Briggs N, Williams DB, Rolan P. The effects of pregabalin and the glial attenuator minocycline on the response to intradermal capsaicin in patients with unilateral sciatica. PLoS One. 2012;7(6):e38525. doi: 10.1371/journal.pone.0038525. Epub 2012 Jun 7.
PubMed 22685578
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Minocycline on Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01869907
- Acronym / sponsor ID
- EMON / EMON
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 5 Jun 2013 (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 study is to determine if minocycline is effective in the treatment of neuropathic pain. The effect of minocycline will be compared to the effect of placebo and amitriptyline.
Detailed description
Neuropathic pain is pain caused by damage to the central or peripheral nervous system. To date, therapy consists of tricyclic antidepressants (such as amitriptyline) or anticonvulsants. However, results are disappointing. Minocycline, a FDA-approved second generation tetracycline, was efficacious in various animal models of neuropathic pain. We want to study the effect of minocycline in neuropathic pain in humans. The type of neuropathic pain we want to investigate is lumbar radicular pain since this is the most prevalent condition associated with neuropathic pain in humans.
This placebo-controlled randomized double blind trial consists of 3 arms:
- Placebo, once daily by mouth during 14 days.
- Amitriptyline 25mg, once daily by mouth during 14 days.
- Minocycline 100mg, once daily by mouth during 14 days.
Patients can take rescue medication if necessary: tramadol 50mg by mouths up to 3-times daily.
Brain-derived neurotrophic factor is implicated in the generation and maintenance of neuropathic pain in different animal models of neuropathic pain. To study the role of brain-derived neurotrophic factor in neuropathic pain in humans, we will determine its concentration in serum and plasma before and after 14 days medication intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboPlacebo, once daily |
| Amitriptyline | Active comparator | Drug: AmitriptylineAmitriptyline 25mg, once daily |
| Minocycline | Active comparator | Drug: MinocyclineMinocycline 100mg, once daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Lumbar radicular pain due to disc herniation, failed back surgery syndrome or spinal canal stenosis causing neuropathic pain
Key exclusion criteria (8 listed)
- Diabetic, alcoholic or drug induced polyneuropathies
- Depression or psychiatric comorbidity affecting pain sensation.
- Use of antidepressants
- Fibromyalgia and Chronic Fatigue Syndrome
- Pregnancy.
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 |
|---|---|---|
| Minocycline100 mg once daily by mouth during 14 days | Drug | Minocycline |
| placeboonce daily by mouth during 14 days | Drug | Placebo |
| Amitriptyline25mg once daily by mouth during 14 days | Drug | Amitriptyline |
Primary outcome
Pain intensity
Time frame: Baseline (before start of study), 7 and 14 days after start of medication intake
Pain intensity will be measured using a visual analogue scale and the change in pain intensity between baseline and day 7, day 7 and day 14, baseline and day 14 will be evaluated
2 secondary outcomes
neuropathic pain diagnostic questionnaire (DN4) score
Time frame: Baseline (before start of study), 7 and 14 days after medication intake
Amount of rescue medication taken
Time frame: 7 and 14 days after medication intake
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 27 Jan 2015.
- Results publication: PubMed 23337936Vanelderen P, Rouwette T, Kozicz T, Heylen R, Van Zundert J, Roubos EW, Vissers K. Effects of chronic administration of amitriptyline, gabapentin and minocycline on spinal brain-derived neurotrophic factor expression and neuropathic pain behavior in a rat chronic constriction injury model. Reg Anesth Pain Med. 2013 Mar-Apr;38(2):124-30. doi: 10.1097/AAP.0b013e31827d611b.
- Results publication: PubMed 22282331Bastos LF, de Oliveira AC, Watkins LR, Moraes MF, Coelho MM. Tetracyclines and pain. Naunyn Schmiedebergs Arch Pharmacol. 2012 Mar;385(3):225-41. doi: 10.1007/s00210-012-0727-1. Epub 2012 Jan 27.
- Results publication: PubMed 19467572Zhang Q, Peng L, Zhang D. Minocycline may attenuate postherpetic neuralgia. Med Hypotheses. 2009 Nov;73(5):744-5. doi: 10.1016/j.mehy.2009.04.028. Epub 2009 May 24.
- Results publication: PubMed 22685578Sumracki NM, Hutchinson MR, Gentgall M, Briggs N, Williams DB, Rolan P. The effects of pregabalin and the glial attenuator minocycline on the response to intradermal capsaicin in patients with unilateral sciatica. PLoS One. 2012;7(6):e38525. doi: 10.1371/journal.pone.0038525. Epub 2012 Jun 7.
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.
Jan Van Zundert, MD, PhD study chair
Ziekenhuis Oost-Limburg
Martine Puylaert, MD study chair
Ziekenhuis Oost-Limburg
Pieter De Vooght, MD study chair
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Minocycline and Amitriptyline in people with Neuropathic Pain Caused by Lumbar Radicular Pain, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
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 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: finished, as of the sponsor's last update on 27 Jan 2015. 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 Belgium. 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?
Pain intensity (time frame: Baseline (before start of study), 7 and 14 days after start of medication intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01869907, which also lists 4 linked publications.
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 27 Jan 2015.