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

Phase 2

Recruiting

• Conditions: Focal Epilepsy; Allopregnanolone; Etifoxine; Resistant epilepsy; Anxiety

• Registration Number: TCTR20210925001
• Lead Sponsor: Faculty Pharmaceutical Science Burapha University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-25
• Study Completion: 2022-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anxiety 3 month HAMA score

Secondary Outcome Measures

Name	Time	Method
Seizure frequency 3 month Seizure diary,Quality of life 3 month QOLILE,Depression 3 month PHQ9