Seizure Rescue Medication for Epilepsy

Phase 4

Recruiting

Led By Martha Sajatovic, MD

Research Sponsored by Martha Sajatovic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 10 week, 24 week

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will be done in two phases. In the first phase, the study team will adapt a program called SMART to help people with epilepsy manage their seizures using Rescue Medication. They will also create

Who is the study for?

This trial is for adults with epilepsy who experience repetitive seizures. Participants should be willing to engage in a comprehensive self-management program, which includes education on using rescue medication (RM) effectively. They must commit to attending several virtual meetings and providing feedback.

What is being tested?

The study tests the SMART RM program, adapted to include rescue medication use for seizure management. Phase 1 involves adapting the program with participant input. In Phase 2, the effectiveness of this tailored SMART-RM will be tested over six months.

What are the potential side effects?

Specific side effects are not detailed here but may relate to Valtoco Nasal Product used as RM; these can include nasal discomfort, an unusual taste in the mouth, or drowsiness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 10 week, 24 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 10 week, 24 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 10 week, 24 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in depressive symptoms as measure by Patient Health Questionnaire (PHQ-9)

Change in epilepsy self management as measure by Epilepsy Self-Efficacy Scale (ESES)

Change in epilepsy self management as measure by Epilepsy Self-Management Scale (ESMS)

+4 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SMART RMExperimental Treatment2 Interventions

The SMART-RM will consist of 8 group-format, 45-60 minute sessions (up to 11 participants per group), which will be collaboratively delivered by a Nurse Educator (NE) and a Peer Educator (PE). The intervention will be remotely delivered in a web-based format using a secure web teleconferencing system (such as Zoom) that will allow us to set up a virtual meeting room. Following the group-session series, participants will have 3 monthly telephone maintenance sessions lasting around 15 minutes. Maintenance session web/telephone calls will be made to study participants by a NE with experience in epilepsy and/or chronic health condition management.

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