Clinical trial NCT01602185: Study of NMDA Antagonists and Neuropathic Pain
Official title: Antagonists NMDA in Relay to Ketamine in Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuropathic Pain
Keywords: NMDA (N-Methyl-D-Aspartate) antagonists
ketamine
memantine
dextromethorphan
Neuropathic pain
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Dr Malou Navez, Pain Clinic, Saint-Etienne Hopital
name: Dr Marc Sorel, Pain Clinic, Nemours Hospital
name: Dr Anne-Margot Duclot, Pain Clinic, Paris Rotschild Hospital
name: Dr Monique Belon, Pain Clinic, Aurillac Hospital
name: Dr Marie-Christine Crosmary/Dr Renato Colamarino, Pain Clinic, Vichy Hospital
name: Dr Mohamed El Ayadi, Pain Clinic, Issoire Hospital
name: Dr Géraldine Brumauld de Montgazon, Pain Clinic, La Rochelle Hospital
First posted: 2012-05-18
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Measure of pain by numerical scale
timeFrame: at Day 30
Secondary outcomes:
measure: Measure of pain by numerical scale
timeFrame: at day 60 and at day 90
measure: Patient Global Impression if Change (PGIC)
timeFrame: at day 30, at day 60 and at day 90
measure: Leed's slip questionnaire
timeFrame: at day 30, at day 60 and at day 90
measure: Questionnaire of quality of life SF 36
timeFrame: at day 30, at day 60 and at day 90
measure: DN4 scale
timeFrame: at day 30, at day 60 and at day 90
measure: Neuropathic Pain Symptoms Inventory (NPSI)
timeFrame: at day 30, at day 60 and at day 90
measure: Saint-Antoine questionnaire (QDSA)
timeFrame: at day 30, at day 60 and at day 90
measure: HAD scale
timeFrame: at day 30, at day 60 and at day 90
measure: Questionnaire of identification of pain (QCD)
timeFrame: at day 30, at day 60 and at day 90
measure: Evaluation of cognitive impact (Cantab, Cambridge)
timeFrame: at day 30, at day 60 and at day 90
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Gisèle PICKERING
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.