Clinical trial NCT01869907: Effect of Minocycline on Pain Caused by Nerve Damage
Official title: Effect of Minocycline on Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuropathic Pain Caused by Lumbar Radicular Pain
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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:

1. Placebo, once daily by mouth during 14 days.
2. Amitriptyline 25mg, once daily by mouth during 14 days.
3. 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.

Eligibility criteria: Inclusion Criteria:

Lumbar radicular pain due to disc herniation, failed back surgery syndrome or spinal canal stenosis causing neuropathic pain

Exclusion Criteria:

1. Diabetic, alcoholic or drug induced polyneuropathies
2. Depression or psychiatric comorbidity affecting pain sensation.
3. Use of antidepressants
4. Fibromyalgia and Chronic Fatigue Syndrome
5. Pregnancy.
6. Previous spinal cord damage
7. Malignancies
8. Allergy to minocycline or amitriptyline

Primary outcomes:
measure: Pain intensity
timeFrame: Baseline (before start of study), 7 and 14 days after start of medication intake
Secondary outcomes:
measure: neuropathic pain diagnostic questionnaire (DN4) score
timeFrame: Baseline (before start of study), 7 and 14 days after medication intake
measure: Amount of rescue medication taken
timeFrame: 7 and 14 days after medication intake
Other outcomes:
measure: Concentration of brain-derived neurotrophic factor (BDNF) in serum and plasma
timeFrame: Baseline (before start of study) and after 14 days of medication intake.
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Jan Van Zundert, MD, PhD
role: STUDY_CHAIR
affiliation: Ziekenhuis Oost-Limburg
name: Martine Puylaert, MD
role: STUDY_CHAIR
affiliation: Ziekenhuis Oost-Limburg
name: Pieter De Vooght, MD
role: STUDY_CHAIR
affiliation: Ziekenhuis Oost-Limburg
name: Roel Mestrum, MD
role: STUDY_CHAIR
affiliation: Ziekenhuis Oost-Limburg
name: René Heylen, MD, PhD
role: STUDY_CHAIR
affiliation: Ziekenhuis Oost-Limburg
name: Pascal Vanelderen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bastos 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.
citation: Zhang 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.
citation: Sumracki 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.