Clinical Trials

A Study of the Thalamus Using Deep Electrode EEG to Better Understand its Participation in the Beginning or Spreading of Seizures

Rochester, MN

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A Study of the Thalamus Using Deep Electrode EEG to Better Understand its Participation in the Beginning or Spreading of Seizures

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to assess the thalamus area of the brain using stereotactic electroencephalography (an EEG with deep electrode placement inside the brain) to better understand its role in the starting and spreading of epileptic seizure activity.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 15-007984
Sponsor Protocol Number:
15-007984

A Study to Assess Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval (EPAS)

Rochester, MN

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A Study to Assess Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval (EPAS)

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this post-approval study is to further evaluate the long-term safety and effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly implanted participants through 3 years of follow-up in different geographic populations.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 19-012307
NCT ID:
NCT03900468
Sponsor Protocol Number:
1677

A Study to Test the Effectiveness and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Jacksonville, FL

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A Study to Test the Effectiveness and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

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Site IRB:
- Jacksonville, Florida: 22-003352
NCT ID:
NCT05077904
Sponsor Protocol Number:
EP0162

Study of the Incidence of Electrographic Status Epilepticus and Seizures of PICU Patients at National Children’s Hospital in Hanoi, Vietnam.

Rochester, MN

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Study of the Incidence of Electrographic Status Epilepticus and Seizures of PICU Patients at National Children’s Hospital in Hanoi, Vietnam.

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of the study is:

To determine the incidence of subclinical electrographic seizures and electrographic status epilepticus in children admitted to the PICU for head trauma, traumatic brain injury (TBI), and/or child abuse at National Children’s Hospital in Hanoi, Vietnam.
To determine whether a correlation exists between length of stay, morbidity, and mortality with incidence of subclinical SE and seizures.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Contact us for the latest status	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 18-004907
Sponsor Protocol Number:
18-004907

A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Jacksonville, FL

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A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Jacksonville, Florida: 22-003485
NCT ID:
NCT05076617

Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures

Rochester, MN

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Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The primary purpose of this study is to evaluate the safety and tolerability of cenobamate in pediatric subjects 2 to ≤ 18 years of age with partial-onset (focal) seizures.

The seconday objectives of this study are to evaluate the efficacy of cenobamate tablets and suspension in pediatric subjects with partial onset (focal) seizures, to collect plasma samples of cenobamate to support the evaluation of the pharmacokinetics of cenobamate tablets and suspension in pediatric subjects with partial onset (focal) seizures, to collect plasma samples of cenobamate to support the evaluation of the PK/pharmacodynamics of cenobamate in pediatric subjects with partial onset (focal) seizures, and the acceptability and palatability assessment (determined by a 5-point Hedonic Scale) of the oral formulation and tablets – Day 1, and Day 15.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 21-010608
NCT ID:
NCT05067634
Sponsor Protocol Number:
YKP3089C040

A Study Evaluating the Use of 48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer’s Disease

Jacksonville, FL

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A Study Evaluating the Use of 48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer’s Disease

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to characterize and study the relationship of the clinical risk factors and predictors of seizures and epilepsy in patients with Early Onset Alzheimer's Disease (EOAD) using a 48-hour CAA-EEG.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Jacksonville, Florida: 19-003078
NCT ID:
NCT04002583
Sponsor Protocol Number:
19-003078

Extension Study to Evaluate How Safe and Tolerable NBI-921352 is as an Adjunctive Therapy for Subjects With SCN8A-DEE

Rochester, MN

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Extension Study to Evaluate How Safe and Tolerable NBI-921352 is as an Adjunctive Therapy for Subjects With SCN8A-DEE

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to evaluate the long-term safety and tolerability of NBI-921352 when administered for up to 106 weeks. Also, to investigate the effect of NBI-921352 on long-term seizure control.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Contact us for the latest status	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 22-007435
NCT ID:
NCT05226780
Sponsor Protocol Number:
NBI-921352 DEE2013

Genetic Markers of Cardiovascular Disease in Epilepsy

Rochester, MN

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Genetic Markers of Cardiovascular Disease in Epilepsy

Location:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

Epilepsy is a common condition which affects over 3 million people in the US. Patients with uncontrolled epilepsy have a lifetime risk of sudden unexpected death (SUDEP) of 35%, which is greatest in those under 40 years of age. The exact mechanisms and causes are not understood but can be due to underlying conditions which affect the heart and brain, which may lead to dangerous heart rhythms and death. Some of these conditions which affect heart and brain have an identifiable genetic cause. This study aims to identify known genetic causes of heart rhythm and sudden death related disorders in patients with epilepsy.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 15-002420
NCT ID:
NCT02824822
Sponsor Protocol Number:
15-002420

A Study to Evaluate Newly-diagnosed Idiopathic Generalized Epilepsy

Rochester, MN

See Details

A Study to Evaluate Newly-diagnosed Idiopathic Generalized Epilepsy

Location:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to identify clinical characteristics and biomarkers predictive of disease outcome, progression, and treatment response in participants with idiopathic generalized epilepsy (IGE).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 20-001343
NCT ID:
NCT05374928

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Search Results 1-10 of 15 for

A Study of the Thalamus Using Deep Electrode EEG to Better Understand its Participation in the Beginning or Spreading of Seizures

A Study to Assess Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval (EPAS)

A Study to Test the Effectiveness and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Study of the Incidence of Electrographic Status Epilepticus and Seizures of PICU Patients at National Children’s Hospital in Hanoi, Vietnam.

A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures

A Study Evaluating the Use of 48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer’s Disease

Extension Study to Evaluate How Safe and Tolerable NBI-921352 is as an Adjunctive Therapy for Subjects With SCN8A-DEE

Genetic Markers of Cardiovascular Disease in Epilepsy

A Study to Evaluate Newly-diagnosed Idiopathic Generalized Epilepsy

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