Study of NMDA Antagonists and Neuropathic Pain (NMDA)

Antagonists NMDA in Relay to Ketamine in 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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain
• Intervention / Treatment: Drug: Memantine (drug used in Alzheimer's disease); Drug: Dextromethorphan (drug used like antitussive); Drug: Placebo (lactose)

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: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Chu Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure of pain by numerical scale	at Day 30

Secondary Outcome Measures

Outcome Measure	Time Frame
Measure of pain by numerical scale	at day 60 and at day 90
Patient Global Impression if Change (PGIC)	at day 30, at day 60 and at day 90
Leed's slip questionnaire	at day 30, at day 60 and at day 90
Questionnaire of quality of life SF 36	at day 30, at day 60 and at day 90
DN4 scale	at day 30, at day 60 and at day 90
Neuropathic Pain Symptoms Inventory (NPSI)	at day 30, at day 60 and at day 90
Saint-Antoine questionnaire (QDSA)	at day 30, at day 60 and at day 90
HAD scale	at day 30, at day 60 and at day 90
Questionnaire of identification of pain (QCD)	at day 30, at day 60 and at day 90
Evaluation of cognitive impact (Cantab, Cambridge)	at day 30, at day 60 and at day 90

Collaborators and Investigators

• 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
• Investigators: Principal Investigator: Gisèle PICKERING, University Hospital, Clermont-Ferrand

Publications and helpful links

General 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.
• Martin E, Sorel M, Morel V, Marcaillou F, Picard P, Delage N, Tiberghien F, Crosmary MC, Najjar M, Colamarino R, Creach C, Lietar B, Brumauld de Montgazon G, Margot-Duclot A, Loriot MA, Narjoz C, Lambert C, Pereira B, Pickering G. Dextromethorphan and memantine after ketamine analgesia: a randomized control trial. Drug Des Devel Ther. 2019 Aug 2;13:2677-2688. doi: 10.2147/DDDT.S207350. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): September 7, 2016

Study Registration Dates

• First Submitted: January 27, 2012
• First Submitted That Met QC Criteria: May 16, 2012
• First Posted (Estimated): May 18, 2012

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Neuropathic pain; ketamine; dextromethorphan; memantine; NMDA (N-Methyl-D-Aspartate) antagonists
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neuralgia; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Membrane Proteins; Polysaccharides; Heterocyclic Compounds, 4 or More Rings; Disaccharides; Oligosaccharides; Sugars; Adamantane; Bridged-Ring Compounds; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Protein Precursors; Amantadine; Amyloidogenic Proteins; Amyloid; Protease Nexins; Proteinase Inhibitory Proteins, Secretory; Dextromethorphan; Memantine; Lactose; Amyloid beta-Protein Precursor
• Other Study ID Numbers: CHU-0112