'Fix the Dysfunction' Concept for Mechanism-based Pharmacological Treatment of Neuropathic Pain by Drug (0381-16)
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|ClinicalTrials.gov Identifier: NCT03276689|
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : April 5, 2019
Introduction Treatment of neuropathic pain has been a goal of numerous research projects for the last half century, with overall disappointing results. These poor achievements are in contrast with substantial advancements in the understanding of pain mechanisms, and numerous molecules developed to tackle them. The need to better identify patients likely to respond to treatment comes from the neuropathic pain experts in regards to the pharmacological domain.
The basic assertion of this project is that the pain modulation profile is altered in pain patients toward a pro-nociceptive mode, and that the specific single or multiple dysfunctions of pain modulation that underlie this pro-nociceptivity should be targeted by therapeutic lines that can reverse the modulation back toward eu-nociceptivity.
The aim of this amendment is to demonstrate that pain treatment efficacy for painful diabetic neuropathy can be optimized by individualizing pharmacological treatment choice along 'fix the dysfunction' concept
|Condition or disease||Intervention/treatment||Phase|
|Neuropathic Pain||Drug: Duloxetine Drug: Pregabaline Other: Placebo||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Treatments The patients will take 2 tab/d of either (i) duloxetine 60mg or (ii) pregabaline 150mg x 2/day or (iii) placebo for 8 weeks. In the first 7 days dose of duloxetine will be 30mg/day in order to lower side effects and improve compliance. In line, the initial 7-days dose of pregabaline will 75mg x 2. For duloxetine, the morning dose will be a sham pill. Study nurse will be available for the patients regarding any side effects or issues arising, and communicate the relevant data to the PI. All personnel and patients will be blinded to the given treatment (double-blind design). The person conducting the immediate and the long term follow up will not know what the results were of the pre-treatment assessments.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||All personnel and patients will be blinded to the given treatment (double-blind design). The person conducting the immediate and the long term follow up will not know what the results were of the pre-treatment assessments.|
|Official Title:||'Fix the Dysfunction' Concept for Mechanism-based Pharmacological Treatment of Neuropathic Pain by Drug|
|Actual Study Start Date :||October 19, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 30, 2020|
The patients will take 2 tab/d of duloxetine 60mg for 8 weeks. In the first 7 days dose of duloxetine will be 30mg/day in order to lower side effects and improve compliance. For duloxetine, the morning dose will be a sham pill.
The patients will take duloxetine for 8 weeks.
The patients will take 2 tab/d of pregabaline 150mg x 2/day for 8 weeks.The initial 7-days dose of pregabaline will 75mg x 2.
The patients will take pregabaline for 8 weeks.
The patients will take 2 tab/d placebo for 8 weeks.
The patients will take placebo for 8 weeks.
- Pain modulation [ Time Frame: During 8 weeks of treatment, every 2 weeks and at the end of the treatment, meaning after 8 weeks from day 1 of the start of medication ]Pain will be measured by using VAS scale from 0 - 100. Resting-state EEG recording along with contact-heat evoked potentials (CHEPs) and assessment of motor cortex excitability, and psychological assessment with pain-related psychological questionnaires, will be collected. .
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): NCT03276689
|Contact: David Yarnitsky, MDemail@example.com|
|Contact: Shiri Fadel, BScfirstname.lastname@example.org|
|Rambam Medical Center||Recruiting|
|Contact: David Yarnitsky, Prof. +972-4-8542605 email@example.com|
|Principal Investigator: David Yarnitsky, Prof.|