Healthy VolunteersPhase 3NCT02147548
Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in the Elderly
A Phase 3 study testing etifoxine and lorazepam in people with Healthy Volunteers, run by Biocodex at 1 site in France.
Trial summary
The purpose of this study is to evaluate the effects of etifoxine (an anxiolytic) compared to lorazepam (a benzodiazepine anxiolytic) on vigilance and cognitive functions in the elderly. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- etifoxine and lorazepam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Oct 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Investigation Clinique, CIC 1403 INSERM/CHRU
Lille, 59037
About this study
Official 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
The purpose of this study is to evaluate the effects of etifoxine (an anxiolytic) compared to lorazepam (a benzodiazepine anxiolytic) on vigilance and cognitive functions in the elderly.
- Conditions
- Healthy Volunteers
- Being tested
- etifoxine, lorazepam, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etifoxineDrug
lorazepamDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| etifoxine (Anxiolytic) | Experimental | etifoxine, 100 mg, a single oral intake Receives: Drug: etifoxine |
| lorazepam | Active comparator | lorazepam, 2 mg, a single oral intake Receives: Drug: lorazepam |
| Placebo | Placebo comparator | 2 capsules of Placebo, a single oral intake Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time (RTI) of Cambridge Neuropsychological Test Automated Batteries (CANTAB)
Measured: 2 hours after the study treatment intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startDec 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocodex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147548
- Sponsor's protocol ID
- ETILANCE - ETI 175
- Status last verified
- Jul 2016
- First submitted
- 22 May 2014
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Deplanque D, Machuron F, Waucquier N, Jozefowicz E, Duhem S, Somers S, Colin O, Duhamel A, Bordet R. Etifoxine impairs neither alertness nor cognitive functions of the elderly: A randomized, double-blind, placebo-controlled crossover study. Eur Neuropsychopharmacol. 2018 Aug;28(8):925-932. doi: 10.1016/j.euroneuro.2018.05.011. Epub 2018 Jun 29.
PubMed 30135030
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02147548
- Acronym / sponsor ID
- ETILANCE - ETI 175
- Conditions
- Healthy Volunteers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- BiocodexIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 26 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effects of etifoxine (an anxiolytic) compared to lorazepam (a benzodiazepine anxiolytic) on vigilance and cognitive functions in the elderly.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| etifoxine (Anxiolytic) | Experimental | Drug: etifoxineetifoxine, 100 mg, a single oral intake |
| lorazepam | Active comparator | Drug: lorazepamlorazepam, 2 mg, a single oral intake |
| Placebo | Placebo comparator | Drug: Placebo2 capsules of Placebo, a single oral intake |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etifoxine | Drug | etifoxine (Anxiolytic) |
| lorazepam | Drug | lorazepam |
| Placebo | Drug | Placebo |
Primary outcome
Reaction time (RTI) of Cambridge Neuropsychological Test Automated Batteries (CANTAB)
Time frame: 2 hours after the study treatment intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- Derived from this study: PubMed 30135030Deplanque D, Machuron F, Waucquier N, Jozefowicz E, Duhem S, Somers S, Colin O, Duhamel A, Bordet R. Etifoxine impairs neither alertness nor cognitive functions of the elderly: A randomized, double-blind, placebo-controlled crossover study. Eur Neuropsychopharmacol. 2018 Aug;28(8):925-932. doi: 10.1016/j.euroneuro.2018.05.011. Epub 2018 Jun 29.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing etifoxine and lorazepam in people with Healthy Volunteers, run by Biocodex at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction time (RTI) of Cambridge Neuropsychological Test Automated Batteries (CANTAB) (time frame: 2 hours after the study treatment intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02147548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2016.