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Prophylaxis of Neuropathic Pain by mémantine (MEMANTINE)

This study is currently recruiting participants.
Verified October 2012 by University Hospital, Clermont-Ferrand
Sponsor:
Collaborators:
Dr Xavier DURANDO/Dr Marie-Ange MOURET/Dr Christine VILLATTE, Jean-Perrin Cancer Center, Clermont-Ferrand Hospital
Pr Claude Dubray, Clinical Pharmacology Center, Inserm 501, Clermont-Ferrand Hospital
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01536314
First received: February 16, 2012
Last updated: October 8, 2012
Last verified: October 2012
History of Changes
  Purpose

The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2 weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared to placebo group.


Condition Intervention Phase
Neuropathic Pain
 Drug: Memantine EBIXA®
Drug: Placebo : lactose
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preventing the Development of Neuropathic Pain Post-mastectomy/Tumorectomy by Pre-emptive or Post-operative Memantine Administration

Resource links provided by NLM:

MedlinePlus related topics: Mastectomy
U.S. FDA Resources

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

Primary Outcome Measures:
  • average painful intensity [ Time Frame: 5 days before visit of 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of pain by numerical scale [ Time Frame: during 15 first days following surgery and to visit of 3 months ] [ Designated as safety issue: Yes ]
  • Average painful [ Time Frame: on 5 days before visit of 6 months post-surgery ] [ Designated as safety issue: Yes ]
  • analgesic consumption [ Time Frame: during 3 months after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Memantine EBIXA®
    The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2 weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared to placebo group.
    Drug: Placebo : lactose
    The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2 weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared to placebo group.
Detailed Description:

The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2 weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared to placebo group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years old
  • patient suffering breast cancer with mastectomy/tumorectomy with or within cleaning 2 weeks after inclusion with or within pre-emptive chemotherapy

Exclusion Criteria:

  • Against-indication at memantine administration : hypersensitivity at active substance or excipients, hypertension, antecedent cerebrovascular accident, severe cardiac insufficiency
  • Diabetic patient (Type I and II)
  • Patient with medical or surgical antecedents
  • Patient receiving treatment with amantadine, ketamine, dextrometorphan, L-Dopa, dopaminergic, anticholinergic agonists, barbiturate, neuroleptic, IMAO, antispastic agents, dantrolen or baclofen, phenitoin, cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine, hydrochlorothiazide, warfarine
  • Patient with alcohol addiction
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536314

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    
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Dr Xavier DURANDO/Dr Marie-Ange MOURET/Dr Christine VILLATTE, Jean-Perrin Cancer Center, Clermont-Ferrand 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: NCT01536314     History of Changes
Other Study ID Numbers: CHU-0115
Study First Received: February 16, 2012
Last Updated: October 8, 2012
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Pre-emptive administration
Post-operative administration
Prophylaxis
 Memantine
Post-mastectomy/tumorectomy
Neuropathic pain

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Memantine
Dopamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013