Diazepam Trial in GAD65 Associated Epilepsy

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of Diazepam in the treatment of high-titer GAD65 associated epilepsy. Subjects will be screened at outpatient clinic visit appointments and identified from lists of patients previously evaluated. There will be a 4-week baseline period where patients will track their seizures. The patient will then be treated with diazepam 5 mg twice daily for 1 week and if tolerating will increase to 10 mg twice daily. Treatment will be continued on the trial for 6 months. Efficacy will be looked at after 2 months of treatment, but the study will be extended to look at tolerability through 6 months. Seizure frequency on treatment will be compared to baseline frequency.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- 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 Criteria:

- Alternative etiology for epilepsy.

- Already on another benzodiazepine.

- On a regularly scheduled opiate.

- Co-existing antibodies associated with seizures.

- Pregnancy or breast feeding.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/19/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Kelsey Smith, M.D.	Open for enrollment	Contact information: Sherry Klingerman CCRP (507) 284-0451 klingerman.sherry@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kelsey Smith, M.D.

Open for enrollment

Contact information:

Sherry Klingerman CCRP

(507) 284-0451

klingerman.sherry@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials