A Phase 2 Randomised Controlled Trial of Sodium Selenate as a Disease Modifying Treatment for Chronic Drug-resistant Temporal Lobe Epilepsy - The SeLECT Study

Phase 2

• Conditions: Mesial temporal lobe epilepsy; Neurological - Epilepsy

• Registration Number: ACTRN12623000446662
• Lead Sponsor: Alfred Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-02
• Last Update Posted: 2 August 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

1. Male or female (aged 18-75 years).
2 Subjects must have a diagnosis of drug-resistant temporal lobe epilepsy (TLE) for at least 2 years at the time of screening.
3. Participants must have 4 or more countable seizures per month (any combination of focal impaired awareness seizures, focal to bilateral tonic clonic seizures or focal aware seizures with motor symptoms)
4. Participants must be on 1 or more stable ASM for a period of >8 weeks
5. Participants must have interictal epileptiform discharges (average >1 spike/hr) on baseline 24-hour EEG localising to one or both temporal lobes without extratemporal discharges or seizures
6. All participants of reproductive potential must be using effective contraception for the duration of the trial and for 4 weeks following cessation of the investigational medicinal product (IMP). Female participants of non-childbearing potential must be either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal at least 1 year. All female participants must have a negative plasma hCG pregnancy test at screening.

Exclusion Criteria

1. Participants with extra-temporal or genetic generalised epilepsy
2 Current or historic substance use disorder (as per DSM V criteria).
2. Women who are pregnant or lactating and persons of reproductive potential unwilling/unable to take adequate contraceptive precaution for the duration of the study are excluded.
3. Participants who have recently (within 3 months of screening) participated in another interventional clinical trial are excluded.
4. Participants who have recent (within 5 years) history of psychogenic non-epileptic seizures, or who have significant medical or neurological disease other than epilepsy that is not adequately controlled by therapy are excluded.
5. Participants who have commenced medications with a known effect on mood, cognition or seizures within 4 weeks of screening are also excluded.
6. Participants with a known sensitivity to selenium, sodium selenate, any medicine or vitamin containing sodium selenate, similar agents or any of the excipients (including microcrystalline cellulose) used are excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in desirability of outcome (DOOR) score between active and placebo groups. <br><br>The DOOR-epilepsy framework is a consumer co-designed outcome measure combining variables of seizure frequency, adverse events, quality of life, and medication burden into a single score. [Change from baseline to 52 weeks post initiation of treatment. ]