Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 61 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

'Fix the Dysfunction' Concept for Mechanism-based Pharmacological Treatment of Neuropathic Pain by Drug (0381-16)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03276689
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
Israel Science Foundation
Information provided by (Responsible Party):
Rambam Health Care Campus

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


Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: Duloxetine Drug: Pregabaline Other: Placebo Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Duloxetine
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
The patients will take duloxetine for 8 weeks.

Experimental: Pregabaline
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
The patients will take pregabaline for 8 weeks.

Experimental: Placebo
The patients will take 2 tab/d placebo for 8 weeks.
Other: Placebo
The patients will take placebo for 8 weeks.




Primary Outcome Measures :
  1. 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. .



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

One-hundred healthy subjects will be recruited, with the same inclusion exclusion criteria.


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): NCT03276689


Contacts
Layout table for location contacts
Contact: David Yarnitsky, MD +972-4-7772605 d_yarnitsky@rambam.health.gov.il
Contact: Shiri Fadel, BSc +972-50-2062161 s_fadel@rambam.health.gov.il

Locations
Layout table for location information
Israel
Rambam Medical Center Recruiting
Haifa, Israel
Contact: David Yarnitsky, Prof.    +972-4-8542605    d_yarnitsky@rmc.gov.il   
Contact       d_yarnitsky@rmc.gov.il   
Principal Investigator: David Yarnitsky, Prof.         
Sponsors and Collaborators
Rambam Health Care Campus
Israel Science Foundation

Layout table for additonal information
Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03276689     History of Changes
Other Study ID Numbers: 0381-16-RMB_CTIL
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuromuscular Diseases
Serotonin and Noradrenaline Reuptake Inhibitors
Neuralgia
Peripheral Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Duloxetine Hydrochloride
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Antidepressive Agents
Dopamine Agents