CompletedNCT01536314MEMANTINEUpdated Aug 5, 2026

Prophylaxis of Neuropathic Pain by mémantine

A Phase 3 interventional study of Memantine EBIXA® and Placebo : lactose in Neuropathic Pain, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by University Hospital, Clermont-Ferrand · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 43
Allocation: Not applicable
Ages: 18 Years and older
Sex: Female

Study summary

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.

Read the detailed description

Conditions studied

Neuropathic Pain

Browse trials for

Neuralgia 1,287

Keywords

Pre-emptive administration
Post-operative administration
Prophylaxis
Memantine
Post-mastectomy/tumorectomy
Neuropathic pain

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 43 is below the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 43 participants (actual)

Interventions

DrugMemantine 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.
DrugPlacebo : 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.

What researchers measure

Primary outcomes

average painful intensity
Time frame: 5 days before visit of 3 months

Secondary outcomes

Evaluation of pain by numerical scale
Time frame: during 15 first days following surgery and to visit of 3 months
Average painful
Time frame: on 5 days before visit of 6 months post-surgery
analgesic consumption
Time frame: during 3 months after surgery

Study locations

1 site

CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France

References and documents

Publications

Morel V, Joly D, Villatte C, Dubray C, Durando X, Daulhac L, Coudert C, Roux D, Pereira B, Pickering G. Memantine before Mastectomy Prevents Post-Surgery Pain: A Randomized, Blinded Clinical Trial in Surgical Patients. PLoS One. 2016 Apr 6;11(4):e0152741. doi: 10.1371/journal.pone.0152741. eCollection 2016. PubMed 27050431 ↗
Pickering G, Morel V, Joly D, Villatte C, Roux D, Dubray C, Pereira B. Prevention of post-mastectomy neuropathic pain with memantine: study protocol for a randomized controlled trial. Trials. 2014 Aug 20;15:331. doi: 10.1186/1745-6215-15-331. PubMed 25142039 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01536314
Lead sponsor: University Hospital, Clermont-Ferrand
Responsible party: Sponsor
First posted: Feb 22, 2012
Start date: Feb 2012
Primary completion: Nov 2013
Completion: Nov 2013
Last update: Aug 5, 2026

Study contacts

Gisèle PICKERING

principal investigator · University Hospital, Clermont-Ferrand

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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