Text Size

Study of NMDA Antagonists and Neuropathic Pain

This study is currently recruiting participants.
Verified October 2012 by University Hospital, Clermont-Ferrand
Sponsor:
Collaborators:
Dr Pascale Picard/Dr Fabienne Riaux-Marcaillou/Dr Noémie Delage, Pain Clinic,Clermont-Ferrand Hospital
Dr Malou Navez, Pain Clinic, Saint-Etienne Hopital
Dr Marc Sorel, Pain Clinic, Nemours Hospital
Dr Anne-Margot Duclot, Pain Clinic, Paris Rotschild Hospital
Dr Monique Belon, Pain Clinic, Aurillac Hospital
Dr Marie-Christine Crosmary/Dr Renato Colamarino, Pain Clinic, Vichy Hospital
Dr Mohamed El Ayadi, Pain Clinic, Issoire Hospital
Dr Géraldine Brumauld de Montgazon, Pain Clinic, La Rochelle Hospital
Pr Claude Dubray, Clinical Pharmacology Center, Inserm 501, Clermont-Ferrand Hospital
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01602185
First received: January 27, 2012
Last updated: October 8, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Neuropathic Pain
 Drug: Dextromethorphan (drug used like antitussive)
Drug: Memantine (drug used in Alzheimer's disease)
Drug: Placebo (lactose)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antagonists NMDA in Relay to Ketamine in Neuropathic Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Measure of pain by numerical scale [ Time Frame: at Day 30 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measure of pain by numerical scale [ Time Frame: at day 60 and at day 90 ] [ Designated as safety issue: Yes ]
  • Patient Global Impression if Change (PGIC) [ Time Frame: at day 30, at day 60 and at day 90 ] [ Designated as safety issue: Yes ]
  • Leed's slip questionnaire [ Time Frame: at day 30, at day 60 and at day 90 ] [ Designated as safety issue: Yes ]
  • Questionnaire of quality of life SF 36 [ Time Frame: at day 30, at day 60 and at day 90 ] [ Designated as safety issue: Yes ]
  • DN4 scale [ Time Frame: at day 30, at day 60 and at day 90 ] [ Designated as safety issue: Yes ]
  • Neuropathic Pain Symptoms Inventory (NPSI) [ Time Frame: at day 30, at day 60 and at day 90 ] [ Designated as safety issue: Yes ]
  • Saint-Antoine questionnaire (QDSA) [ Time Frame: at day 30, at day 60 and at day 90 ] [ Designated as safety issue: Yes ]
  • HAD scale [ Time Frame: at day 30, at day 60 and at day 90 ] [ Designated as safety issue: Yes ]
  • Questionnaire of identification of pain (QCD) [ Time Frame: at day 30, at day 60 and at day 90 ] [ Designated as safety issue: Yes ]
  • Evaluation of cognitive impact (Cantab, Cambridge) [ Time Frame: at day 30, at day 60 and at day 90 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: memantine
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
Experimental: dextromethorphan
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)
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 Comparator: placebo
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602185

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN     04 73 75 11 95     placarin@chu-clermontferrand.fr    
CHU Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN     04 73 75 11 95     placarin@chu-clermontferrand.fr    
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Dr Pascale Picard/Dr Fabienne Riaux-Marcaillou/Dr Noémie Delage, Pain Clinic,Clermont-Ferrand Hospital
Dr Malou Navez, Pain Clinic, Saint-Etienne Hopital
Dr Marc Sorel, Pain Clinic, Nemours Hospital
Dr Anne-Margot Duclot, Pain Clinic, Paris Rotschild Hospital
Dr Monique Belon, Pain Clinic, Aurillac Hospital
Dr Marie-Christine Crosmary/Dr Renato Colamarino, Pain Clinic, Vichy Hospital
Dr Mohamed El Ayadi, Pain Clinic, Issoire Hospital
Dr Géraldine Brumauld de Montgazon, Pain Clinic, La Rochelle Hospital
Pr Claude Dubray, Clinical Pharmacology Center, Inserm 501, Clermont-Ferrand Hospital
Investigators
Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01602185     History of Changes
Other Study ID Numbers: CHU-0112
Study First Received: January 27, 2012
Last Updated: October 8, 2012
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
NMDA (N-Methyl-D-Aspartate) antagonists
ketamine
memantine
dextromethorphan
Neuropathic pain

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Antitussive Agents
Dextromethorphan
Guaifenesin
Phenylpropanolamine
Chlorpheniramine, phenylpropanolamine drug combination
Ketamine
Memantine
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Expectorants
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013