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Study of NMDA Antagonists and Neuropathic Pain (NMDA)

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: NCT01602185
Recruitment Status : Completed
First Posted : May 18, 2012
Last Update Posted : October 11, 2017
Sponsor:
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
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Tracking Information
First Submitted Date  ICMJE January 27, 2012
First Posted Date  ICMJE May 18, 2012
Last Update Posted Date October 11, 2017
Actual Study Start Date  ICMJE May 2012
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2012)		 Measure of pain by numerical scale [ Time Frame: at Day 30 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2012)
  • Measure of pain by numerical scale [ Time Frame: at day 60 and at day 90 ]
  • Patient Global Impression if Change (PGIC) [ Time Frame: at day 30, at day 60 and at day 90 ]
  • Leed's slip questionnaire [ Time Frame: at day 30, at day 60 and at day 90 ]
  • Questionnaire of quality of life SF 36 [ Time Frame: at day 30, at day 60 and at day 90 ]
  • DN4 scale [ Time Frame: at day 30, at day 60 and at day 90 ]
  • Neuropathic Pain Symptoms Inventory (NPSI) [ Time Frame: at day 30, at day 60 and at day 90 ]
  • Saint-Antoine questionnaire (QDSA) [ Time Frame: at day 30, at day 60 and at day 90 ]
  • HAD scale [ Time Frame: at day 30, at day 60 and at day 90 ]
  • Questionnaire of identification of pain (QCD) [ Time Frame: at day 30, at day 60 and at day 90 ]
  • Evaluation of cognitive impact (Cantab, Cambridge) [ Time Frame: at day 30, at day 60 and at day 90 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of NMDA Antagonists and Neuropathic Pain
Official Title  ICMJE Antagonists NMDA in Relay to Ketamine in Neuropathic Pain
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuropathic Pain
Intervention  ICMJE
  • Drug: Dextromethorphan (drug used like antitussive)
    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
  • Drug: Memantine (drug used in Alzheimer's disease)
    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
  • Drug: Placebo (lactose)
    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
Study Arms  ICMJE
  • Experimental: memantine
    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: Drug: Memantine (drug used in Alzheimer's disease)
  • Experimental: dextromethorphan
    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: Drug: Dextromethorphan (drug used like antitussive)
  • Placebo Comparator: placebo
    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: Drug: Placebo (lactose)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2017)		 7
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2012)		 60
Actual Study Completion Date  ICMJE September 7, 2016
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01602185
Other Study ID Numbers  ICMJE CHU-0112
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital, Clermont-Ferrand
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Clermont-Ferrand
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • 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
Investigators  ICMJE
Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP