'Fix the Dysfunction' Concept for Mechanism-based Pharmacological Treatment of Neuropathic Pain by Drug

NCT03276689 | Completed

• 1 other identifier: 0381-16-RMB_CTIL
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Pain modulation

  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. .

  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

Study Arms (3)

Duloxetine

EXPERIMENTAL

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.

Drug: Duloxetine

Pregabaline

EXPERIMENTAL

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.

Drug: Pregabaline

Placebo

EXPERIMENTAL

The patients will take 2 tab/d placebo for 8 weeks.

Other: Placebo

Interventions

Duloxetine DRUG

The patients will take duloxetine for 8 weeks.

Duloxetine

Pregabaline DRUG

The patients will take pregabaline for 8 weeks.

Pregabaline

Placebo OTHER

The patients will take placebo for 8 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age of 18-80 yrs,
• both genders, \* non-pregnant or breast feeding,
• free of significant chronic pain syndromes other than the neuropathy,
• free of major neurological or psychiatric disorders such as dementia, psychosis and similar.

You may not qualify if:

• \*communication and language difficulties that hinder their performance in the various tests.

Sponsors & Collaborators

• Rambam Health Care Campus: lead
• Israel Science Foundation: collaborator

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: September 8, 2017
• Study Start: October 19, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 30, 2020
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)