NCT05361447

Brief Summary

The purpose of this study is to determine whether diazepam reduces the frequency of seizures in GAD65 antibody associated epilepsy.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

January 11, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2024

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

1.9 years

First QC Date

May 1, 2022

Last Update Submit

March 4, 2025

Conditions

GAD 65 Antibody-associated Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Change in seizure frequency

    Median percentage change in the mean monthly frequency of seizures as measured by patient recorded seizure frequency

    Baseline, 3 months

Study Arms (1)

GAD65 Associated Epilepsy

EXPERIMENTAL

Subjects diagnosed with GAD65 associated epilepsy, serum high-titer GAD65 positivity, trialed and failed at least 2 anti-seizure medications, at least 4 seizures per month will be started on diazepam.

Drug: Diazepam

Interventions

DiazepamDRUG

5 mg twice daily oral for 1 week and then increase to 10 mg twice daily oral

Also known as: Valium
GAD65 Associated Epilepsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Alternative etiology for epilepsy.
  • Already on another benzodiazepine.
  • On a regularly scheduled opiate.
  • Co-existing antibodies associated with seizures.
  • Pregnancy or breast feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Interventions

Diazepam

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Kelsey Smith, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 1, 2022

First Posted

May 4, 2022

Study Start

January 11, 2023

Primary Completion

December 13, 2024

Study Completion

December 13, 2024

Last Updated

March 6, 2025

Record last verified: 2025-03

Locations

US(1)