Prophylaxis of Neuropathic Pain by mémantine (MEMANTINE)

This study has been completed.
Sponsor:
Collaborator:
Dr Xavier DURANDO/Dr Marie-Ange MOURET/Dr Christine VILLATTE, Jean-Perrin Cancer Center, Clermont-Ferrand Hospital
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01536314
First received: February 16, 2012
Last updated: June 30, 2014
Last verified: June 2014
  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:


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 ]

Enrollment: 43
Study Start Date: February 2012
Study Completion Date: November 2013
Primary Completion Date: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536314

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Dr Xavier DURANDO/Dr Marie-Ange MOURET/Dr Christine VILLATTE, Jean-Perrin Cancer Center, 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: June 30, 2014
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
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents

ClinicalTrials.gov processed this record on September 15, 2014