Prophylaxis of Neuropathic Pain by mémantine

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01536314
• Date of registration: 16/02/2012
• Prospective Registration: No
• Primary sponsor: University Hospital, Clermont-Ferrand
• Public title: Prophylaxis of Neuropathic Pain by mémantine MEMANTINE
• Scientific title: Preventing the Development of Neuropathic Pain Post-mastectomy/Tumorectomy by Pre-emptive or Post-operative Memantine Administration
• Date of first enrolment: February 2012
• Target sample size: 43
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01536314
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Gisèle PICKERING
• Affiliation: University Hospital, Clermont-Ferrand

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Neuropathic Pain

Intervention(s)

Drug: Placebo : lactose

Drug: Memantine EBIXA®

Primary Outcome(s)

average painful intensity [Time Frame: 5 days before visit of 3 months]

Secondary Outcome(s)

analgesic consumption [Time Frame: during 3 months after surgery]

Average painful [Time Frame: on 5 days before visit of 6 months post-surgery]

Evaluation of pain by numerical scale [Time Frame: during 15 first days following surgery and to visit of 3 months]

Secondary ID(s)

CHU-0115

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Dr Xavier DURANDO/Dr Marie-Ange MOURET/Dr Christine VILLATTE, Jean-Perrin Cancer Center, Clermont-Ferrand Hospital