Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in the Elderly

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT02147548
• Date of registration: 22/05/2014
• Prospective Registration: No
• Primary sponsor: Biocodex
• Public title: Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in the Elderly
• Scientific title: Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in the Elderly. A Monocentric, Randomized, Cross-over, Double-blind Clinical Study Versus Placebo
• Date of first enrolment: December 2013
• Target sample size: 31
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02147548
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
• Phase: Phase 3

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion Criteria:

- Man or woman aged from 65 to 75 years

- Right-handed subject (Edinburgh Handedness inventory)

- Subject having signed the consent form

- Subject having agreed to be listed on the French National Healthy Volunteers database

- Subject affiliated or beneficiary to French social insurance

Exclusion Criteria:

- Subject presenting a neurological or psychiatric disease notably cognitive,
progressing

- Anxious subject (Hamilton score > 7 and/or Spielberger score > 51 for a man or > 61
for a woman)

- Left-handed subject (Edinburgh Handedness inventory)

- Subject presenting a not corrected visual disease or a motor function disease that
could interfere with tests realization

- Smoker

- Subject taking one or more psychotropics or apparent products

- Subject having taken, during the previous month, one or more drugs that could
interfere with study drugs metabolism

- Subject drinking too much coffee or tea (> 4 cups per day) or alcohol (>½ liter of
wine or equivalent per day)

- Subject presenting contra-indication to one of the drugs used in the study

- Subject with past history of intolerance to drugs used in the study

- Subject not capable to use the CANTAB cognitive evaluation system

- Subject which may not be able to participate to the whole study

- Subject under tutelage or guardianship

- Subject not able to well-understand French and so to understand cognitive tests

- Subject not capable to swallow capsules

- Subject participating to another study or in exclusion period (3 months after a
previous trial).



Age minimum: 65 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Intervention(s)

Drug: Placebo

Drug: etifoxine

Drug: lorazepam

Primary Outcome(s)

Reaction time (RTI) of Cambridge Neuropsychological Test Automated Batteries (CANTAB) [Time Frame: 2 hours after the study treatment intake]

Secondary ID(s)

ETILANCE - ETI 175

Source(s) of Monetary Support

Please refer to primary and secondary sponsors