Role of etifoxine, as an adjunctive treatment in patients diagnosed with medically resistant focal epilepsy with comorbid anxiety symptoms (The ETIFOXs)

Role of etifoxine, as an adjunctive treatment in patients diagnosed with medically resistant focal epilepsy with comorbid anxiety symptoms

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210925001

Enrollment

Registered

2021-09-25

Start date

2021-04-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focal Epilepsy Allopregnanolone Etifoxine Resistant epilepsy Anxiety

Interventions

Etifoxine 100 mg every 12 hour (totally 200 mg/day) for 3 month ,Placebo 100 mg every 12 hour (totally 200 mg/day) for 3 month

Active Comparator Drug,Placebo Comparator Drug

Etifoxine group,Placebo

Eligibility

Sex/Gender

All

Age

20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1 Age more than 20 years old 2 Diagnosed with medically resistant focal epilepsy 2.1 Average seizure frequency more than 3 times/month, determine from the past 3 months with on at least two antiepileptic drugs (AEDs) or expose to at least 2 sequential monotherapy, with proper dosage no history of poor compliance to AEDs 3 Comorbid mild to sever anxiety symptoms defined as HAMA score of more than 1 point 4 Can maintainable the same concomitant AEDs, other neuropsychiatric medications and hormonal medications with stable dosage throughout the study 4.1 From 1 months before the study to entire 3 months after the enrolment 4.2 Allow a rescue medications i.e. a benzodiazepine medicine only 1 to 2 time a week 5 In reproductive potential patients, must accept to use at least one methods of birth control

Exclusion criteria

Exclusion criteria: 1. Any history or presence of hepatic disease 2. Myasthenia gravis 3 Patients with congenital galactosemia, glucose and galactose malabsorption syndrome or lactase deficit 4 Unsuitable veins for repeated venipuncture 5 Inability or difficulty swallowing whole capsules 6 History of alcohol abuse 7 Pregnancy, lactation and plan to conceive 8 Simultaneous participation to a clinical trial or in exclusion period of a previous clinical trial 9 Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol 10 Currently taking more than 2 antidepressants 11 Currently taking more than 2 benzodiazepines 12 Currently taking ONLY 1 benzodiazepine but the dosage is very high: alprazolam (10 mg/d), diazepam (40 mg/d), chlordiazepoxide (100 mg/d), clobazam (40 mg/d), clonazepam (40 mg/d), flunitrazepam (2 mg/d), lorazepam (10 mg/d) , midazolam (20 mg/d) 13 Currently taking morphine or its derivative, antipsychotic agents, recreational agents CBD, etc., herbal medicines (Withdrawal period must be at least 3 months before screening.) 14 History of poor medication adherence 15 Baseline GFR less than 30 ml/min 16 Advance cancer or severe medical conditions 17 Severe psychiatric illness and history of suicidal idea or attempts 18 Previous history of status epilepticus within 1 year 19 Currently on etifoxine or progesterone therapy 20 Previous history of allergic to etifoxine or progesterone

Design outcomes

Primary

Measure	Time frame
Anxiety 3 month HAMA score	—

Secondary

Measure	Time frame
Seizure frequency 3 month Seizure diary,Quality of life 3 month QOLILE,Depression 3 month PHQ9	—

Countries

Thailand

Contacts

Public ContactSiriphong Thanapatphakin

Burapha University

siriphong.tk@gmail.com0855329419

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026