Study of NMDA Antagonists and Neuropathic Pain

NCT01602185 | Completed Phase 2

• 1 other identifier: CHU-0112
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Keywords

NMDA (N-Methyl-D-Aspartate) antagonists; ketamine; memantine; dextromethorphan; Neuropathic pain

Outcome Measures

Primary Outcomes (1)

• Measure of pain by numerical scale

  at Day 30

Secondary Outcomes (10)

• 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

Study Arms (3)

memantine

EXPERIMENTAL

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)

dextromethorphan

EXPERIMENTAL

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)

placebo

PLACEBO COMPARATOR

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)

Interventions

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

dextromethorphan

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

memantine

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

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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 treated by an IMAO
• Woman in childbearing age not using effective contraceptive method, pregnant or lactating woman
• 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

Sponsors & Collaborators

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

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (2)

• 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.

  PMID: 31447547 RESULT

• 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.

  PMID: 24948402 DERIVED

MeSH Terms

Conditions

Neuralgia

Interventions

Dextromethorphan; Memantine; Amyloid beta-Protein Precursor; Lactose

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Amyloidogenic Proteins; Amyloid; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Protein Precursors; Protease Nexins; Proteinase Inhibitory Proteins, Secretory; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Gisèle PICKERING

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: May 18, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: September 7, 2016
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

FR (1)