Study of NMDA Antagonists and Neuropathic Pain

Phase 2

Completed

• Conditions: Neuropathic Pain
• Interventions: Drug: Memantine (drug used in Alzheimer's disease); Drug: Dextromethorphan (drug used like antitussive); Drug: Placebo (lactose)

• Registration Number: NCT01602185
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study First Submitted: 2012-01-27
• Study Start: 2012-05
• Study First Submitted QC: 2012-05-16
• Study First Posted: 2012-05-18
• Primary Completion: 2014-06
• Study Completion: 2016-09-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
memantine	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
dextromethorphan	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	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

Primary Outcome Measures

Name	Time	Method
Measure of pain by numerical scale	at Day 30

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression if Change (PGIC)	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
Leed's slip questionnaire	at day 30, at day 60 and at day 90
DN4 scale	at day 30, at day 60 and at day 90
Saint-Antoine questionnaire (QDSA)	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
Measure of pain by numerical scale	at day 60 and at day 90
Questionnaire of quality of life SF 36	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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France