Study of NMDA Antagonists and Neuropathic Pain

Neuropathic Pain Clinical Trial

— NMDA  

Official title:

Antagonists NMDA in Relay to Ketamine in Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01602185
• Other study ID #: CHU-0112
• Status: Completed
• Phase: Phase 2
• First received: January 27, 2012
• Last updated: October 10, 2017
• Start date: May 2012
• Est. completion date: September 7, 2016

Study information

• Verified date: October 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 7, 2016
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (8)

Lead Sponsor

Collaborator

University Hospital, Clermont-Ferrand

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

Country where clinical trial is conducted

France, 

Outcome

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