Ziekenhuis Oost-Limburg
Genk, Limburg, 3600, Belgium
NCT Number: NCT01869907
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 4
Genk, Limburg, 3600, Belgium
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Lumbar radicular pain due to disc herniation, failed back surgery syndrome or spinal canal stenosis causing neuropathic pain
Exclusion criteria
100 mg once daily by mouth during 14 days
once daily by mouth during 14 days
25mg once daily by mouth during 14 days
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
Time frame: Baseline (before start of study), 7 and 14 days after medication intake
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
Time frame: 7 and 14 days after medication intake
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
Time frame: Baseline (before start of study) and after 14 days of medication intake.
A blood sample (10ml) will be taken at baseline and after 14 days medication intake. The concentration of brain derived neurotrophic factor will be determined by high sensitivity ELISA (R&D systems® Europe, United Kingdom; detection range: 20-4,000 pg/ml) and the change in BDNF-concentration in serum and plasma between baseline and day 14 will be evaluated.
Ziekenhuis Oost-Limburg
Other
Effect of Minocycline on Neuropathic Pain
Acronym: EMON
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