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Completed

NCT Number: NCT01602185

Study of NMDA Antagonists and Neuropathic Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dextromethorphan (drug used like antitussive)

Drug

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

Memantine (drug used in Alzheimer's disease)

Drug

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 (lactose)

Drug

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 outcomes

  1. Measure of pain by numerical scale

    Time frame: at Day 30

Secondary outcomes

  1. Measure of pain by numerical scale

    Time frame: at day 60 and at day 90

  2. Patient Global Impression if Change (PGIC)

    Time frame: at day 30, at day 60 and at day 90

  3. Leed's slip questionnaire

    Time frame: at day 30, at day 60 and at day 90

  4. Questionnaire of quality of life SF 36

    Time frame: at day 30, at day 60 and at day 90

  5. DN4 scale

    Time frame: at day 30, at day 60 and at day 90

  6. Neuropathic Pain Symptoms Inventory (NPSI)

    Time frame: at day 30, at day 60 and at day 90

  7. Saint-Antoine questionnaire (QDSA)

    Time frame: at day 30, at day 60 and at day 90

  8. HAD scale

    Time frame: at day 30, at day 60 and at day 90

  9. Questionnaire of identification of pain (QCD)

    Time frame: at day 30, at day 60 and at day 90

  10. Evaluation of cognitive impact (Cantab, Cambridge)

    Time frame: at day 30, at day 60 and at day 90

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Dr Anne-Margot Duclot, Pain Clinic, Paris Rotschild Hospital
  • Dr Géraldine Brumauld de Montgazon, Pain Clinic, La Rochelle Hospital
  • Dr Malou Navez, Pain Clinic, Saint-Etienne Hopital
  • Dr Marc Sorel, Pain Clinic, Nemours Hospital
  • Dr Marie-Christine Crosmary/Dr Renato Colamarino, Pain Clinic, Vichy Hospital
  • Dr Mohamed El Ayadi, Pain Clinic, Issoire Hospital
  • Dr Monique Belon, Pain Clinic, Aurillac Hospital

Registry information

Official study title

Antagonists NMDA in Relay to Ketamine in Neuropathic Pain

Acronym: NMDA

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
May 18, 2012
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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