Status:
WITHDRAWN
Diazepam Trial in GAD65 Associated Epilepsy
Lead Sponsor:
Mayo Clinic
Conditions:
GAD 65 Antibody-associated Epilepsy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine whether diazepam reduces the frequency of seizures in GAD65 antibody associated epilepsy.
Detailed Description
GAD65 is an intracellular enzyme that plays a key role in the conversion of glutamate to gamma-aminobutyric acid (GABA), the primary inhibitory neurotransmitter in the CNS. Benzodiazepines augment the...
Eligibility Criteria
Inclusion
- High-titer serum GAD65 positivity \> 20 nmol/L High-titer serum GAD65 IgG seropositivity titer \>20 nmol/L and/or CSF GAD65 seropositivity titer \> 0.02 nmol/L.
- Drug-resistant focal epilepsy, having failed 2 previous anti-seizure medications.
- Stable treatment for the 1 month prior to enrollment.
- Patients must be able to give informed consent or have an appropriate representative available to do.
Exclusion
- Alternative etiology for epilepsy.
- Already on another benzodiazepine.
- On a regularly scheduled opiate.
- Co-existing antibodies associated with seizures.
- Pregnancy or breast feeding.
Key Trial Info
Start Date :
January 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05361447
Start Date
January 11 2023
End Date
December 13 2024
Last Update
March 6 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905