EpilepsyPhase 4NCT06346262
Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care
A Phase 4 study testing SMART RM and Valtoco Nasal Product in people with Epilepsy, run by University Hospitals Cleveland Medical Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- SMART RM and Valtoco Nasal Product
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Mar 2024to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Phase 1 Patient with epilepsy inclusion criteria:
- 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
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- Phase 1 Caregiver inclusion criteria
- 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
- Phase 1 Provider inclusion criteria
- 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
- Be 18 years or older
- Be able to speak and understand English
- Be able to provide written, informed consent to study participation
- Inclusion criteria for participants who will receive SMART-RM:
- Have received a previous diagnosis of epilepsy
- Be adults ≥ age 18,
- While on a regimen of anti-epileptic medication, still be experiencing bouts of seizures (e.g. frequent break through or acute repetitive seizures) distinct from their usual seizure pattern , and, in the opinion of the study epilepsy clinician, may need benzodiazepine intervention for seizure control
- Have experienced at least 3 seizures but not more than 100 seizures in the previous 6 months. If there have only been 3 seizures in the last 6 months, two of the seizures should be within approximately 24 hours of each other (not more than 48 hours apart)
- Be able to speak and understand English
- Be able to provide written, informed consent to study participation
Who cannot join
- Exclusion criteria for participants who will receive SMART-RM:
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Hospitals Medical Center
Cleveland, Ohio, 44106
Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital
New York, New York, 10029
About this study
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
- Being tested
- SMART RM, Valtoco Nasal Product
- Keywords
- Epilepsy Self Management, Epilepsy, Seizure, Reduction medication, Anti-seizure medication
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART RMBehavioural
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).
Valtoco Nasal ProductDrug
Medication dosing will follow recommendations in the Valtoco package insert and managed by the epilepsy clinician.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SMART RM; Drug: Valtoco Nasal Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of seizures as measured by patient report.
Measured: Baseline, 6 months
Secondary outcomes (10)
Change in quality of life as measure by QOLIE-31
Quality of life (QOL) will be assessed using the QOLIE-31, a validated tool to assess quality of life specifically in people with epilepsy with higher numbers reflecting a more favorable health state.
Measured: Baseline, 10 week, 24 week
Change in functional status as measure by Short-Form Health Survey (SF-36)
Functional status will be assessed using the 36-item Short-Form Health Survey (SF-36), a multipurpose, short-form health survey with 36 questions that yields two psychometrically based components: a physical component summary and mental component summary. Scores range from 0 (worst functioning) to 100 (best functioning). The SF-36 is a generic measure of functional health status and has proven useful for comparing the relative burden of diseases.
Measured: Baseline, 10 week, 24 week
Change in depressive symptoms as measure by Patient Health Questionnaire (PHQ-9)
Depressive symptom severity will be assessed using the nine- item Patient Health Questionnaire (PHQ-9), a widely used and validated self-rated depression scale. The PHQ-9 incorporates Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria, with scores ranging from 0 to 27. Higher scores indicate worse depression severity. The PHQ-9 has been widely used to measure depressive symptom severity in epilepsy.
Measured: Baseline, 10 week, 24 week
Change in epilepsy self management as measure by Epilepsy Self-Efficacy Scale (ESES)
Self-efficacy will be measured using the 33-item Epilepsy Self-Efficacy Scale (ESES), with scores ranging from 0 to 330 and higher scores indicating better self-efficacy. Social support will be measured with the 12-item.
Measured: Baseline, 10 week, 24 week
Change in epilepsy self management as measure by Multidimensional Scale of Perceived Social Support (MSPSS)
Multidimensional Scale of Perceived Social Support (MSPSS), which measures perception of social support provided by family and friends, as well as satisfaction with that support. The MSPSS score ranges from 1 to 84, with higher scores indicating better social support.
Measured: Baseline, 10 week, 24 week
Change in epilepsy self management as measure by Epilepsy Self-Management Scale (ESMS)
Overall epilepsy self-management competency will be measured using the Epilepsy Self-Management Scale (ESMS); scores range from 1 to 190, with higher scores indicating better self-management of epilepsy.
Measured: Baseline, 10 week, 24 week
Change in epilepsy self management as measure by Epilepsy Stigma Scale (ESS)
Stigma for epilepsy will be measured using the Epilepsy Stigma Scale (ESS) In the ESS, scores range from 7 to 70; each item is rated on a 7-point scale from strongly disagree to strongly agree, with higher numbers indicating greater perceived stigma
Measured: Baseline, 10 week, 24 week
Change in number of emergency room visit as measure by patient report
Measured: Baseline, 10 week, 24 week
Change in number of hospitalizations as measure by patient report
Measured: Baseline, 10 week, 24 week
Change in number of non study outpatient services utilization as measure by patient report
Measured: Baseline, 10 week, 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start5 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha Sajatovic, University Hospitals Cleveland Medical Center
- Investigators
- Martha Sajatovic, MD, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346262
- Sponsor's protocol ID
- STUDY20230921
- Status last verified
- Jul 2026
- First submitted
- 22 Mar 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care
- ClinicalTrials.gov ID
- NCT06346262
- Acronym / sponsor ID
- STUDY20230921
- Conditions
- Epilepsy
- Keywords
- Epilepsy Self Management, Epilepsy, Seizure, Reduction medication, Anti-seizure medication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMART RM | Experimental | Behavioral: SMART RM, Drug: Valtoco Nasal ProductThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMART RMThe 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). | Behavioural | SMART RM |
| Valtoco Nasal ProductMedication dosing will follow recommendations in the Valtoco package insert and managed by the epilepsy clinician. | Drug | SMART RM |
Primary outcome
Change in number of seizures as measured by patient report.
Time frame: Baseline, 6 months
10 secondary outcomes
Change in quality of life as measure by QOLIE-31
Time frame: Baseline, 10 week, 24 week
Change in functional status as measure by Short-Form Health Survey (SF-36)
Time frame: Baseline, 10 week, 24 week
Change in depressive symptoms as measure by Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 10 week, 24 week
Change in epilepsy self management as measure by Epilepsy Self-Efficacy Scale (ESES)
Time frame: Baseline, 10 week, 24 week
Change in epilepsy self management as measure by Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Baseline, 10 week, 24 week
Change in epilepsy self management as measure by Epilepsy Self-Management Scale (ESMS)
Time frame: Baseline, 10 week, 24 week
Change in epilepsy self management as measure by Epilepsy Stigma Scale (ESS)
Time frame: Baseline, 10 week, 24 week
Change in number of emergency room visit as measure by patient report
Time frame: Baseline, 10 week, 24 week
Change in number of hospitalizations as measure by patient report
Time frame: Baseline, 10 week, 24 week
Change in number of non study outpatient services utilization as measure by patient report
Time frame: Baseline, 10 week, 24 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Sajatovic, MD principal investigator
University Hospitals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SMART RM and Valtoco Nasal Product in people with Epilepsy, run by University Hospitals Cleveland Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of seizures as measured by patient report. (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.