Diazepam Trial in GAD65 Associated Epilepsy
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-007195
NCT ID: NCT05361447
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Kelsey Smith, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available