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Neuropathic Pain | Study of NMDA Antagonists and Neuropathic Pain

Neuropathic Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Neuropathic Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

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

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

memantineThe aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity

dextromethorphanThe aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity

placeboThe aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity

Study Status

Completed

Start Date: May 2012

Completed Date: September 7, 2016

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Measure of pain by numerical scale

Secondary Outcome: Measure of pain by numerical scale

Study sponsors, principal investigator, and references

Principal Investigator: Gisèle PICKERING

Lead Sponsor: University Hospital, Clermont-Ferrand

Collaborator: Dr Malou Navez, Pain Clinic, Saint-Etienne Hopital

More information:https://clinicaltrials.gov/show/NCT01602185

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