Trial | NCT01869907  Report issue

Title

Effect of Minocycline on Pain Caused by Nerve Damage
Effect of Minocycline on Neuropathic Pain

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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.
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 Started
Sep 30
2011
Primary Completion
Aug 31
2014
Study Completion
Aug 31
2014
Last Update
Jan 27
2015
Estimate

Drug Minocycline

100 mg once daily by mouth during 14 days

Drug placebo

once daily by mouth during 14 days

Drug Amitriptyline

25mg once daily by mouth during 14 days

Placebo Placebo Comparator

Placebo, once daily

Amitriptyline Active Comparator

Amitriptyline 25mg, once daily

Minocycline Active Comparator

Minocycline 100mg, once daily

Criteria 

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
No Results Posted