Cluster SeizureNCT06056349
Benzodiazepine Study for the Treatment of Seizure Clusters in a Third Level Mexican Neurological Center
A study testing Midazolam oral solution, ClonazePAM Oral Product and Usual medication/ traditional in people with Cluster Seizure, run by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez at 1 site in Mexico.
Trial summary
The aim of this study is to determine the efficacy in seizure reduction when comparing orodispersable clonazepam versus usual treatment (i.e. medication load, intravenous high- dose benzodiazepines) of seizure clusters in a third level center of care in Mexico city. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cluster Seizure
- What is being tested?
- Midazolam oral solution, ClonazePAM Oral Product and Usual medication/ traditional
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteMexico
- Study dates
- 1 May 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least age of 18
- Patient available for follow-up
- Previous diagnosis of epilepsy
- Patient meets criteria for seizure clusters (3 or more seizures in a period of 24 hours)
Who cannot join
- Risk factors for epilepsy have been identified and uncontrolled.
- Younger than 18 years olf
- Follow- up in another healthcare unit
- No previous epilepsy diagnosis
- Adequate control of epilepsy
- Patient meets criteria for clinical or electrographic status epilepticus.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Neurología y Neurocirugía "Dr. Manuel Velasco Suárez"
Mexico City, Mexico City, 14269
Elma M Paredes- Aragón, MD, 55 5606 3822 ext. 1058, elma.paredes@innn.edu.mx
Juan Carlos Lopez Hernandez, MD, 55 5606 3822 ext. 1058, juanca9684@hotmail.com
About this study
Official title: An Open Label Benzodiazepine Study for the Treatment of Seizure Clusters in a Third Level Mexican Neurological Center
The aim of this study is to determine the efficacy in seizure reduction when comparing orodispersable clonazepam versus usual treatment (i.e. medication load, intravenous high- dose benzodiazepines) of seizure clusters in a third level center of care in Mexico city.
Read the detailed description
This is an open label, randomized, prospective clinical trial, with a 1:1:1 aleatorization of a single third level specialized neurological center.
Primary objective: To evaluate the clinical impact of the use of buccal midazolam as a treatment of seizure clusters in comparison with orodispersable clonazepam vs usual care.
Secondary objective: To identify patients that present seizure clusters and risk factors associated with the diagnosis. To evaluate the quality of life after drug administration, to evaluate the adverse events associated with the medications. To establish seizure recurrence and mortality in 6 months' follow up.
- Conditions
- Cluster Seizure
- Being tested
- Midazolam oral solution, ClonazePAM Oral Product, Usual medication/ traditional
- Keywords
- seizure cluster, epilepsy, rescue medication, benzodiazepines
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam oral solutionDrug
Also called midazolam
Buccal administration
ClonazePAM Oral ProductDrug
Also called clonazepam
Orodispersable
Usual medication/ traditionalOther
Medication that is usually used in the emergency department
| Study group | Role | What they receive |
|---|---|---|
| Orodispersable clonazepam | Experimental | 50 patients will receive oral orodispersable clonazepam. Receives: Drug: ClonazePAM Oral Product |
| Buccal midazolam | Experimental | 50 patients will receive buccal midazolam. Receives: Drug: Midazolam oral solution |
| Conventional treatment | Active comparator | 50 patients will receive "usual/ conventional treatment of seizure clusters" Receives: Other: Usual medication/ traditional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline seizure frequency comparison using buccal midazolam, orodispersable clonazepam versus usual care efficacy for seizure clusters
Seizure frequency description, using the Engel Score of Seizure Outcomes
Measured: 1,3 and 6 months
Secondary outcomes (2)
Change from baseline seizure recurrence in 6 months
Seizure frequency description, using the Engel Score of Seizure outcomes.
Measured: 6 months
Change from baseline quality of life assessed by the QOLIE-31 from baseline
Quality of life questionnaire: QOLIE-31 (Quality Of Life in Epilepsy version 31) is a standarized epilepsy quality of life measuring tool compared to initial score at recruitment. QOLIE-31 consists of 31 items distributed in 7 areas: preoccupation for seizures, general quality of life, emotional well-being, energy/fatigue, cognitive alterations, medication effects, and social functioning. Final evaluation of the points is ranging from 10 points (worse quality of life) and 50 points (best quality of life).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 May 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster SeizureStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This is an open label, randomnized, prospective clinical trial, with a 1:1:1 aleatorization of a single third level specialized neurological center.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elma Paredes-Aragón, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
- Investigators
- Elma M Paredes-Aragón, MD, Principal investigator, National Institute of Neurology and Neurosurgery, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056349
- Sponsor's protocol ID
- 05/23
- Status last verified
- May 2024
- First submitted
- 25 Apr 2023
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Benzodiazepine Study for the Treatment of Seizure Clusters in a Third Level Mexican Neurological Center
- ClinicalTrials.gov ID
- NCT06056349
- Acronym / sponsor ID
- 05/23
- Conditions
- Cluster Seizure
- Keywords
- seizure cluster, epilepsy, rescue medication, benzodiazepines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Sep 2023 (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.
The aim of this study is to determine the efficacy in seizure reduction when comparing orodispersable clonazepam versus usual treatment (i.e. medication load, intravenous high- dose benzodiazepines) of seizure clusters in a third level center of care in Mexico city.
Detailed description
This is an open label, randomized, prospective clinical trial, with a 1:1:1 aleatorization of a single third level specialized neurological center.
Primary objective: To evaluate the clinical impact of the use of buccal midazolam as a treatment of seizure clusters in comparison with orodispersable clonazepam vs usual care.
Secondary objective: To identify patients that present seizure clusters and risk factors associated with the diagnosis. To evaluate the quality of life after drug administration, to evaluate the adverse events associated with the medications. To establish seizure recurrence and mortality in 6 months' follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is an open label, randomnized, prospective clinical trial, with a 1:1:1 aleatorization of a single third level specialized neurological center.
| Arm | Type | Receives |
|---|---|---|
| Orodispersable clonazepam | Experimental | Drug: ClonazePAM Oral Product50 patients will receive oral orodispersable clonazepam. |
| Buccal midazolam | Experimental | Drug: Midazolam oral solution50 patients will receive buccal midazolam. |
| Conventional treatment | Active comparator | Other: Usual medication/ traditional50 patients will receive "usual/ conventional treatment of seizure clusters" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least age of 18
- Patient available for follow-up
- Previous diagnosis of epilepsy
- Patient meets criteria for seizure clusters (3 or more seizures in a period of 24 hours)
Key exclusion criteria (6 listed)
- Risk factors for epilepsy have been identified and uncontrolled.
- Younger than 18 years olf
- Follow- up in another healthcare unit
- No previous epilepsy diagnosis
- Adequate control of epilepsy
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 |
|---|---|---|
| Midazolam oral solutionAlso: midazolamBuccal administration | Drug | Buccal midazolam |
| ClonazePAM Oral ProductAlso: clonazepamOrodispersable | Drug | Orodispersable clonazepam |
| Usual medication/ traditionalMedication that is usually used in the emergency department | Other | Conventional treatment |
Primary outcome
Change from baseline seizure frequency comparison using buccal midazolam, orodispersable clonazepam versus usual care efficacy for seizure clusters
Time frame: 1,3 and 6 months
Seizure frequency description, using the Engel Score of Seizure Outcomes
2 secondary outcomes
Change from baseline seizure recurrence in 6 months
Time frame: 6 months
Change from baseline quality of life assessed by the QOLIE-31 from baseline
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No
Related trials for Cluster Seizure
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.
Elma M Paredes-Aragón, MD principal investigator
National Institute of Neurology and Neurosurgery, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam oral solution, ClonazePAM Oral Product and Usual medication/ traditional in people with Cluster Seizure, run by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez at 1 site in Mexico.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elma M Paredes-Aragón, MD (5556063822 ext. 1058, elma.paredes@innn.edu.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline seizure frequency comparison using buccal midazolam, orodispersable clonazepam versus usual care efficacy for seizure clusters (time frame: 1,3 and 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 31 May 2024.