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Prophylaxis of Neuropathic Pain by mémantine (MEMANTINE)

U

University Hospital, Clermont-Ferrand

Status and phase

Completed
Phase 3

Conditions

Neuropathic Pain

Treatments

Drug: Placebo : lactose
Drug: Memantine EBIXA®

Study type

Interventional

Funder types

Other

Identifiers

NCT01536314
CHU-0115

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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