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Study of NMDA Antagonists and Neuropathic Pain (NMDA)

Primary Purpose

Neuropathic Pain

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Dextromethorphan (drug used like antitussive)
Memantine (drug used in Alzheimer's disease)
Placebo (lactose)
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring NMDA (N-Methyl-D-Aspartate) antagonists, ketamine, memantine, dextromethorphan, Neuropathic pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • > 18 years old
  • patient suffering chronic neuropathic pain
  • All chronic pain is retained except central or diabetic pain
  • Answering patient at ketamine in pain treatment by investigator, and having already received ketamine
  • Patient who completed before ketamine the following evaluation :

DN4, QCD, QDSA, PGIC questionnaires, HAD scale, Leed's sleep evaluation and SF36.

  • Patient who completed at the end of treatment the following evaluation : numerical scale and PGIC
  • Sufficient cooperation and understanding to comply to the requirements of study
  • Acceptance to give a written concert
  • Affiliation at system of French social security
  • Inscription or acceptation of inscription at national register of voluntaries participant at research

Exclusion Criteria:

  • Against-indication at memantine or dextromethorphan administration : hypersensitivity at active substance or excipients, hypertension, antecedent cerebrovascular accident, severe cardiac insufficiency
  • Patient with medical or surgical antecedents
  • Patient with progressive disease at balance of inclusion
  • Patient treated by an IMAO
  • Woman in childbearing age not using effective contraceptive method, pregnant or lactating woman
  • Patient who participated in another clinical trial, located in exclusion period or received benefits > 4500 euros during 12 months before the beginning of trial
  • Patient with cooperation and understanding insufficiency to comply to the requirements of protocol
  • Patient with social protection
  • No affiliation at system of French social security

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

memantine

dextromethorphan

placebo

Arm Description

The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity

The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity

The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity

Outcomes

Primary Outcome Measures

Measure of pain by numerical scale

Secondary Outcome Measures

Measure of pain by numerical scale
Patient Global Impression if Change (PGIC)
Leed's slip questionnaire
Questionnaire of quality of life SF 36
DN4 scale
Neuropathic Pain Symptoms Inventory (NPSI)
Saint-Antoine questionnaire (QDSA)
HAD scale
Questionnaire of identification of pain (QCD)
Evaluation of cognitive impact (Cantab, Cambridge)

Full Information

First Posted
January 27, 2012
Last Updated
October 10, 2017
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Dr Malou Navez, Pain Clinic, Saint-Etienne Hopital, Dr Marc Sorel, Pain Clinic, Nemours Hospital, Dr Anne-Margot Duclot, Pain Clinic, Paris Rotschild Hospital, Dr Monique Belon, Pain Clinic, Aurillac Hospital, Dr Marie-Christine Crosmary/Dr Renato Colamarino, Pain Clinic, Vichy Hospital, Dr Mohamed El Ayadi, Pain Clinic, Issoire Hospital, Dr Géraldine Brumauld de Montgazon, Pain Clinic, La Rochelle Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01602185
Brief Title
Study of NMDA Antagonists and Neuropathic Pain
Acronym
NMDA
Official Title
Antagonists NMDA in Relay to Ketamine in Neuropathic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (Actual)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 7, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Dr Malou Navez, Pain Clinic, Saint-Etienne Hopital, Dr Marc Sorel, Pain Clinic, Nemours Hospital, Dr Anne-Margot Duclot, Pain Clinic, Paris Rotschild Hospital, Dr Monique Belon, Pain Clinic, Aurillac Hospital, Dr Marie-Christine Crosmary/Dr Renato Colamarino, Pain Clinic, Vichy Hospital, Dr Mohamed El Ayadi, Pain Clinic, Issoire Hospital, Dr Géraldine Brumauld de Montgazon, Pain Clinic, La Rochelle Hospital

4. Oversight

5. Study Description

Brief Summary
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity. In clinical, after ketamine cure, clinicians have often difficulties to treat patients in order to maintain analgesia or suggest another treatment if analgesia induced by ketamine was not effective, which occurs in one quarter of patients. It will be very useful for monitoring of painful patients evaluate if memantine or dextromethorphan could be an effective therapeutic alternative in neuropathic pain treatment.
Detailed Description
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity. In clinical, after ketamine cure, clinicians have often difficulties to treat patients in order to maintain analgesia or suggest another treatment if analgesia induced by ketamine was not effective, which occurs in one quarter of patients. It will be very useful for monitoring of painful patients evaluate if memantine or dextromethorphan could be an effective therapeutic alternative in neuropathic pain treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
NMDA (N-Methyl-D-Aspartate) antagonists, ketamine, memantine, dextromethorphan, Neuropathic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
memantine
Arm Type
Experimental
Arm Description
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity
Arm Title
dextromethorphan
Arm Type
Experimental
Arm Description
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity
Intervention Type
Drug
Intervention Name(s)
Dextromethorphan (drug used like antitussive)
Intervention Description
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity
Intervention Type
Drug
Intervention Name(s)
Memantine (drug used in Alzheimer's disease)
Intervention Description
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity
Intervention Type
Drug
Intervention Name(s)
Placebo (lactose)
Intervention Description
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity
Primary Outcome Measure Information:
Title
Measure of pain by numerical scale
Time Frame
at Day 30
Secondary Outcome Measure Information:
Title
Measure of pain by numerical scale
Time Frame
at day 60 and at day 90
Title
Patient Global Impression if Change (PGIC)
Time Frame
at day 30, at day 60 and at day 90
Title
Leed's slip questionnaire
Time Frame
at day 30, at day 60 and at day 90
Title
Questionnaire of quality of life SF 36
Time Frame
at day 30, at day 60 and at day 90
Title
DN4 scale
Time Frame
at day 30, at day 60 and at day 90
Title
Neuropathic Pain Symptoms Inventory (NPSI)
Time Frame
at day 30, at day 60 and at day 90
Title
Saint-Antoine questionnaire (QDSA)
Time Frame
at day 30, at day 60 and at day 90
Title
HAD scale
Time Frame
at day 30, at day 60 and at day 90
Title
Questionnaire of identification of pain (QCD)
Time Frame
at day 30, at day 60 and at day 90
Title
Evaluation of cognitive impact (Cantab, Cambridge)
Time Frame
at day 30, at day 60 and at day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 18 years old patient suffering chronic neuropathic pain All chronic pain is retained except central or diabetic pain Answering patient at ketamine in pain treatment by investigator, and having already received ketamine Patient who completed before ketamine the following evaluation : DN4, QCD, QDSA, PGIC questionnaires, HAD scale, Leed's sleep evaluation and SF36. Patient who completed at the end of treatment the following evaluation : numerical scale and PGIC Sufficient cooperation and understanding to comply to the requirements of study Acceptance to give a written concert Affiliation at system of French social security Inscription or acceptation of inscription at national register of voluntaries participant at research Exclusion Criteria: Against-indication at memantine or dextromethorphan administration : hypersensitivity at active substance or excipients, hypertension, antecedent cerebrovascular accident, severe cardiac insufficiency Patient with medical or surgical antecedents Patient with progressive disease at balance of inclusion Patient treated by an IMAO Woman in childbearing age not using effective contraceptive method, pregnant or lactating woman Patient who participated in another clinical trial, located in exclusion period or received benefits > 4500 euros during 12 months before the beginning of trial Patient with cooperation and understanding insufficiency to comply to the requirements of protocol Patient with social protection No affiliation at system of French social security
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisèle PICKERING
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24948402
Citation
Pickering G, Pereira B, Morel V, Tiberghien F, Martin E, Marcaillou F, Picard P, Delage N, de Montgazon G, Sorel M, Roux D, Dubray C. Rationale and design of a multicenter randomized clinical trial with memantine and dextromethorphan in ketamine-responder patients. Contemp Clin Trials. 2014 Jul;38(2):314-20. doi: 10.1016/j.cct.2014.06.004. Epub 2014 Jun 16.
Results Reference
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Study of NMDA Antagonists and Neuropathic Pain

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