Comparing two medications for treating seizure clusters in adults
An Open Label Benzodiazepine Study for the Treatment of Seizure Clusters in a Third Level Mexican Neurological Center
NA · El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez · NCT06056349
This study is testing whether a new form of clonazepam works better than standard treatments for reducing seizure clusters in adults with epilepsy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez (other) |
| Locations | 1 site (Mexico City, Mexico City) |
| Trial ID | NCT06056349 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of orodispersable clonazepam compared to usual treatment methods for reducing seizure clusters in adults diagnosed with epilepsy. Conducted at a specialized neurological center in Mexico City, the study employs an open-label, randomized design with a 1:1:1 allocation of participants to receive either buccal midazolam, orodispersable clonazepam, or standard care. The primary objective is to assess the clinical impact of these treatments, while secondary objectives include evaluating quality of life, adverse events, seizure recurrence, and mortality over a six-month follow-up period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a previous diagnosis of epilepsy who experience seizure clusters.
Not a fit: Patients with well-controlled epilepsy or those who do not meet the criteria for seizure clusters may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients experiencing seizure clusters.
How similar studies have performed: Other studies have shown promise in using benzodiazepines for seizure management, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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.
Where this trial is running
Mexico City, Mexico City
- Instituto Nacional de Neurología y Neurocirugía "Dr. Manuel Velasco Suárez" — Mexico City, Mexico City, Mexico (RECRUITING)
Study contacts
- Principal investigator: Elma M Paredes-Aragón, MD — National Institute of Neurology and Neurosurgery
- Study coordinator: Elma M Paredes-Aragón, MD
- Email: elma.paredes@innn.edu.mx
- Phone: 5556063822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cluster Seizure, seizure cluster, epilepsy, rescue medication, benzodiazepines