Filter Results

Clinical Studies

Open

  • A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Outpatient, Parallel-Group Study To Assess The Efficacy And Safety Of Staccato Alprazolam In Study Participants 12 Years Of Age And Older With Stereotypical Prolonged Seizures Jacksonville, FL

    The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration.

  • A Prospective Study To Evaluate The Use Of The Minder Device To Aid In Developing A Treatment Plan After Inconclusive Prolonged EEG In Patients With Epilepsy Scottsdale/Phoenix, AZ Rochester, MN The purpose of this research is to address the challenges of diagnosing and long-term management of epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research will compare the Minder System to standard of care in providing reliable seizure data. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational.

    Participants will consent to join the study and be implanted with the Minder device; or consent to join the study and continue with their Standard of Care (SOC) as a control group. Participants chose to be implanted with the Minder device will have the device implanted under their scalp. After implantation, participants will be randomly assigned to a group where their treating physician will have access to the EEG data collected by the Minder System or a group where their treating physician does not have access to the EEG data collected by the Minder System. Participants receiving the Minder System will not know which group they are in (blinded) until the study ends.

    All participants will continue to be followed by their treating physician and undergo assessments and visits until enough information is available to determine a treatment plan or the 6-month follow-up visit.
  • An Open-Label, Multicenter, Outpatient Extension Study To Evaluate The Safety And Tolerability Of Staccato Alprazolam In Study Participants 12 Years Of Age And Older With Stereotypical Prolonged Seizures Jacksonville, FL

    The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.

  • Utility of Smartphone Videos For Diagnosis of Seizures: Is The Accuracy of Smartphone Video Diagnosis Enough to Omit Video Electroencephalogram Monitoring in Certain Patients? Jacksonville, FL

    This is a multi-center study with an overall aim of evaluating the accuracy to which neurologists can discriminate seizures from other epileptic, nonepileptic or physiologic seizures by home video recordings, with the overall goal of determining whether this is a feasible diagnostic method in settings where video electroencephalogram monitoring  (VEM) may be limited.  

    This will be achieved by obtaining smartphone video recordings from consecutive adult patients with the intent of admission to the epilepsy monitoring unit to capture the seizure. Adults included will have a confirmed electroclinical diagnosis by video-EEG monitoring of the event of concern, classified as either epileptic or non- epileptic seizure, or physiologic event.  The videos will be reviewed, and qualitative analysis determined as definite seizure, probable or unable to indeterminate epileptic, non epileptic or physiologic seizure. The answer will also include a quantitative scale rating the certainty of diagnosis. Classifications will be compared to electroclinical diagnosis for assessment of accuracy.  

    The videos will be reviewed, and qualitative analysis determined as definite seizure, probable or unable to indeterminate epileptic, non epileptic or physiologic seizure. The answer will also include a quantitative scale rating the certainty of diagnosis. Classifications will be compared to electroclinical diagnosis for assessment of accuracy.

Contact Us for the Latest Status

  • A Prospective Study To Evaluate The Use Of The Minder Device To Aid In Developing A Treatment Plan After Inconclusive Prolonged EEG In Patients With Epilepsy Jacksonville, FL The purpose of this research is to address the challenges of diagnosing and long-term management of epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research will compare the Minder System to standard of care in providing reliable seizure data. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational.

    Participants will consent to join the study and be implanted with the Minder device; or consent to join the study and continue with their Standard of Care (SOC) as a control group. Participants chose to be implanted with the Minder device will have the device implanted under their scalp. After implantation, participants will be randomly assigned to a group where their treating physician will have access to the EEG data collected by the Minder System or a group where their treating physician does not have access to the EEG data collected by the Minder System. Participants receiving the Minder System will not know which group they are in (blinded) until the study ends.

    All participants will continue to be followed by their treating physician and undergo assessments and visits until enough information is available to determine a treatment plan or the 6-month follow-up visit.
  • A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study To Evaluate The Safety, Tolerability, And Efficacy Of XEN1101 As Adjunctive Therapy In Focal-Onset Seizures Jacksonville, FL

    The purpose of this study is to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.

  • Timed Get Up & Go: An Analysis Of Antiepileptic Medication (AED) & Gait Jacksonville, FL

    The purpose of this study is to examine the effect of AEDs on gait and fall risk utilizing CaptureProof’s Timed Get UP & Go (TUG) AI technology.

Closed for Enrollment

.