Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care

NCT06346262 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STUDY20230921
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This study will be done in two phases. Using stakeholder input (community advisory board (CAB)), the study team will adapt the SMART program to incorporate education and self-management support for use of Rescue Medication (RM) to manage seizure occurrence among Persons With Epilepsy (PWE) who have repetitive seizures. Additional content/support materials, pending input stakeholder might include posters/hand-outs that present information on the use of RM in a way that is engaging and salient to PWE. It is expected that participants will be in Phase 1 for about 3 months and participate in the CAB 2 or 3 times via zoom for 60-90 minutes/meeting. The advisory board will provide input on needed refinement of an adapted version of SMART based on their individual experiences. It is anticipate the total time commitment to be no more than 6 hours over 3 months, spread out over 2-3 meetings with review of materials possible in between meetings. Phase 2: The investigators will use a 6-month prospective trial design to test engagement with and effects of SMART-RM among approximately 35 adult (≥ 18 years) PWE who have repetitive seizures.

Conditions

Epilepsy

Keywords

Epilepsy Self Management; Epilepsy; Seizure; Reduction medication; Anti-seizure medication

Outcome Measures

Primary Outcomes (1)

• Change in number of seizures as measured by patient report.

  Baseline, 6 months

Secondary Outcomes (10)

• Change in quality of life as measure by QOLIE-31

  Baseline, 10 week, 24 week

• Change in functional status as measure by Short-Form Health Survey (SF-36)

  Baseline, 10 week, 24 week

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

  Baseline, 10 week, 24 week

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

  Baseline, 10 week, 24 week

• Change in epilepsy self management as measure by Multidimensional Scale of Perceived Social Support (MSPSS)

  Baseline, 10 week, 24 week

Study Arms (1)

SMART RM

EXPERIMENTAL

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.

Behavioral: SMART RM; Drug: Valtoco Nasal Product

Interventions

SMART RM BEHAVIORAL

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).

SMART RM

Valtoco Nasal Product DRUG

Medication dosing will follow recommendations in the Valtoco package insert and managed by the epilepsy clinician.

SMART RM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have epilepsy
• Have experience with RM
• Be 18 years or older
• Be able to speak and understand English
• Be able to provide written, informed consent to study participation
• Provide care support to an individual with epilepsy
• Be 18 years or older
• Be able to speak and understand English
• Be able to provide written, informed consent to study participation
• Provide care for individuals with epilepsy - this may include (not limited to) physician, nurse practitioner, physician assistant, nurse, social worker, psychologist
• Be 18 years or older
• Be able to speak and understand English
• Be able to provide written, informed consent to study participation
• Have epilepsy
• Have experience with RM

You may not qualify if:

• Individuals who have had allergic reaction to diazepam or who have medical/psychiatric that are contraindications to the use of diazepam
• Individuals prescribed opioid medications
• Individuals with acute narrow angle glaucoma
• Individuals with known dependence on benzodiazepines or current benzodiazepine abuse.
• Actively suicidal/homicidal
• Individuals with a diagnosis of dementia
• Individuals who are unable to provide written informed consent to participate in study and who do not have a legally authorized representative or individuals who are unable to participate in study procedures.
• Pregnant women

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (2)

Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

University Hospitals Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martha Sajatovic, MD

  University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Research Coordinator

CONTACT

1-888-819-0004; jessica.black@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, UHMG

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 4, 2024
• Study Start: March 5, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)