Trial Outcomes & Findings for Neocortical Epilepsies - Do They Progress? (NCT NCT00610558)

Last Updated: 2019-11-20

Results Overview

We will analyze the structural and metabolic differences between two epilepsy groups (JME and FLE) and understand the imaging presentations of epilepsy patients. We will process imaging requisition for Arm 1 and Arm 2 patients and the controls to examine if any differences in their brain image. The hypothesis is the functional connectivity between brainstem structures and cortical/subcortical regions may reflect in their imaging data. We would like to know if these imaging factors are related to epilepsy (JME and FLE) patients.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

During Imaging Session

Results posted on

2019-11-20

Participant Flow

There is no pre-assignment for this study

Participant milestones

Participant milestones
Measure	Arm 1: Juvenile Myoclonic Epilepsy Subjects who are eligible for this group will participate MRI imaging	Arm 2: Frontal Lobe Epilepsy Subjects who are eligible for this group will participate MRI imaging	Arm 3: Normal Cont Subjects who are eligible for this group will participate MRI imaging
Overall Study STARTED	20	20	20
Overall Study COMPLETED	15	14	14
Overall Study NOT COMPLETED	5	6	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neocortical Epilepsies - Do They Progress?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm1: Juvenile Myoclonic Epilepsy n=15 Participants Subject will are eligible for this group will participate the MRI imaging	Arm 2: Frontal Lobe Epilepsy n=14 Participants Subject will are eligible for this group will participate the MRI imaging	Arm 3: Normal Controls n=14 Participants Subject will are eligible for this group will participate the MRI imaging	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	43 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	38 years STANDARD_DEVIATION 6.5 • n=5 Participants	37 years STANDARD_DEVIATION 6.8 • n=7 Participants	40 years STANDARD_DEVIATION 7.7 • n=5 Participants	38.3 years STANDARD_DEVIATION 7.1 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	20 Participants n=4 Participants
Region of Enrollment United States	15 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	43 Participants n=4 Participants

PRIMARY outcome

Timeframe: During Imaging Session

Population: This protocol has been closed about 10 years ago. All files have been destroyed per IRB requirement.

Outcome measures

Outcome data not reported

Adverse Events

Arm 1: Juvenile Myoclonic Epilepsy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2: Frontal Lobe Epilepsy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 3: Normal Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1: Juvenile Myoclonic Epilepsy n=15 participants at risk 15 Subjects were monitored/assessed, but none observed	Arm 2: Frontal Lobe Epilepsy n=14 participants at risk 14 Subjects were monitored/assessed, but none observed	Arm 3: Normal Controls n=14 participants at risk 14 Subjects were monitored/assessed, but none observed
General disorders Allergic reactions to the contrasts	0.00% 0/15 • Subjects monitored for safety events during the entire imaging session; up to 1 hour All-Cause Mortality, Serious, and non-serious Adverse Events were monitored/assessed, but none observed	0.00% 0/14 • Subjects monitored for safety events during the entire imaging session; up to 1 hour All-Cause Mortality, Serious, and non-serious Adverse Events were monitored/assessed, but none observed	0.00% 0/14 • Subjects monitored for safety events during the entire imaging session; up to 1 hour All-Cause Mortality, Serious, and non-serious Adverse Events were monitored/assessed, but none observed

Other adverse events

Other adverse events
Measure	Arm 1: Juvenile Myoclonic Epilepsy n=15 participants at risk 15 Subjects were monitored/assessed, but none observed	Arm 2: Frontal Lobe Epilepsy n=14 participants at risk 14 Subjects were monitored/assessed, but none observed	Arm 3: Normal Controls n=14 participants at risk 14 Subjects were monitored/assessed, but none observed
General disorders Bleeding, soreness or swelling of injection site	0.00% 0/15 • Subjects monitored for safety events during the entire imaging session; up to 1 hour All-Cause Mortality, Serious, and non-serious Adverse Events were monitored/assessed, but none observed	0.00% 0/14 • Subjects monitored for safety events during the entire imaging session; up to 1 hour All-Cause Mortality, Serious, and non-serious Adverse Events were monitored/assessed, but none observed	0.00% 0/14 • Subjects monitored for safety events during the entire imaging session; up to 1 hour All-Cause Mortality, Serious, and non-serious Adverse Events were monitored/assessed, but none observed

Additional Information

Dr. Lydia Su

University of California, Irvine

Phone: (949) 824-4925

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place