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

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ClinicalTrials.gov Identifier: NCT01869907
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : January 27, 2015
Sponsor:
Information provided by (Responsible Party):
Pascal Vanelderen, Ziekenhuis Oost-Limburg

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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Caused by Lumbar Radicular Pain Drug: Minocycline Drug: placebo Drug: Amitriptyline Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Minocycline on Neuropathic Pain
Study Start Date : September 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo, once daily
Drug: placebo
once daily by mouth during 14 days

Active Comparator: Amitriptyline
Amitriptyline 25mg, once daily
Drug: Amitriptyline
25mg once daily by mouth during 14 days

Active Comparator: Minocycline
Minocycline 100mg, once daily
Drug: Minocycline
100 mg once daily by mouth during 14 days




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869907


Locations
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Belgium
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium, 3600
Sponsors and Collaborators
Ziekenhuis Oost-Limburg
Investigators
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Study Chair: Jan Van Zundert, MD, PhD Ziekenhuis Oost-Limburg
Study Chair: Martine Puylaert, MD Ziekenhuis Oost-Limburg
Study Chair: Pieter De Vooght, MD Ziekenhuis Oost-Limburg
Study Chair: Roel Mestrum, MD Ziekenhuis Oost-Limburg
Study Chair: René Heylen, MD, PhD Ziekenhuis Oost-Limburg
Principal Investigator: Pascal Vanelderen, MD Ziekenhuis Oost-Limburg

Publications of Results:
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Responsible Party: Pascal Vanelderen, Principal Investigator, Ziekenhuis Oost-Limburg
ClinicalTrials.gov Identifier: NCT01869907     History of Changes
Other Study ID Numbers: EMON
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Minocycline
Amitriptyline
Amitriptyline, perphenazine drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants