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Study of NMDA Antagonists and Neuropathic Pain (NMDA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01602185
First Posted: May 18, 2012
Last Update Posted: October 11, 2017
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.
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
  Purpose

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.


Condition Intervention Phase
Neuropathic Pain Drug: Dextromethorphan (drug used like antitussive) Drug: Memantine (drug used in Alzheimer's disease) Drug: Placebo (lactose) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antagonists NMDA in Relay to Ketamine in Neuropathic Pain

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Measure of pain by numerical scale [ Time Frame: at Day 30 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 7
Actual Study Start Date: May 2012
Study Completion Date: September 7, 2016
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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
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
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT01602185


Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
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
Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01602185     History of Changes
Other Study ID Numbers: CHU-0112
First Submitted: January 27, 2012
First Posted: May 18, 2012
Last Update Posted: October 11, 2017
Last Verified: October 2017

Keywords provided by University Hospital, Clermont-Ferrand:
NMDA (N-Methyl-D-Aspartate) antagonists
ketamine
memantine
dextromethorphan
Neuropathic pain

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Ketamine
Memantine
Dextromethorphan
Antitussive Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Respiratory System Agents