Effect of Minocycline on Pain Caused by Nerve Damage (EMON)

East Limburg Hospital

Status and phase: Completed; Phase 4

Conditions: Neuropathic Pain Caused by Lumbar Radicular Pain

Treatments: Drug: Amitriptyline; Drug: placebo; Drug: Minocycline

Study type: Interventional

Funder types: Other

Identifiers

NCT01869907

EMON

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo, once daily

Treatment:

Drug: placebo

Amitriptyline

Active Comparator group

Description:

Amitriptyline 25mg, once daily

Treatment:

Drug: Amitriptyline

Minocycline

Active Comparator group

Description:

Minocycline 100mg, once daily

Treatment:

Drug: Minocycline