Effect of Minocycline on Pain Caused by Nerve Damage (EMON)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01869907|
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : January 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Neuropathic Pain Caused by Lumbar Radicular Pain||Drug: Minocycline Drug: placebo Drug: Amitriptyline||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
Placebo Comparator: Placebo
Placebo, once daily
once daily by mouth during 14 days
Active Comparator: Amitriptyline
Amitriptyline 25mg, once daily
25mg once daily by mouth during 14 days
Active Comparator: Minocycline
Minocycline 100mg, once daily
100 mg once daily by mouth during 14 days
- 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
- 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
- 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.
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
|Genk, Limburg, Belgium, 3600|
|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|