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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

Tracking Information
First Submitted Date  ICMJE May 27, 2013
First Posted Date  ICMJE June 5, 2013
Last Update Posted Date January 27, 2015
Study Start Date  ICMJE September 2011
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2013)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 2, 2013)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Minocycline on Pain Caused by Nerve Damage
Official Title  ICMJE Effect of Minocycline on Neuropathic Pain
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neuropathic Pain Caused by Lumbar Radicular Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo, once daily
    Intervention: Drug: placebo
  • Active Comparator: Amitriptyline
    Amitriptyline 25mg, once daily
    Intervention: Drug: Amitriptyline
  • Active Comparator: Minocycline
    Minocycline 100mg, once daily
    Intervention: Drug: Minocycline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01869907
Other Study ID Numbers  ICMJE EMON
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pascal Vanelderen, Ziekenhuis Oost-Limburg
Study Sponsor  ICMJE Ziekenhuis Oost-Limburg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Ziekenhuis Oost-Limburg
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP