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Completed

NCT Number: NCT01869907

Effect of Minocycline on Pain Caused by Nerve Damage

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

About this study

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.

Who can participate

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

  • 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

Treatment and study plan

Minocycline

Drug

100 mg once daily by mouth during 14 days

Placebo

Drug

once daily by mouth during 14 days

Amitriptyline

Drug

25mg once daily by mouth during 14 days

Primary outcomes

  1. 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

Secondary outcomes

  1. neuropathic pain diagnostic questionnaire (DN4) score

    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

  2. Amount of rescue medication taken

    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

Other outcomes

  1. Concentration of brain-derived neurotrophic factor (BDNF) in serum and plasma

    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.

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Registry information

Official study title

Effect of Minocycline on Neuropathic Pain

Acronym: EMON

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 5, 2013
Registry last updated
Jan 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.