Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02126774




Registration number
NCT02126774
Ethics application status
Date submitted
28/04/2014
Date registered
30/04/2014
Date last updated
6/07/2021

Titles & IDs
Public title
The Human Epilepsy Project
Scientific title
The Human Epilepsy Project
Secondary ID [1] 0 0
12-02865
Universal Trial Number (UTN)
Trial acronym
HEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Focal Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
focal epilepsy - observational study
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of Biomarker(s) Predictive of Anti-epileptic Drug Treatment Response
Timepoint [1] 0 0
up to 36 months

Eligibility
Key inclusion criteria
* Clinical seizure(s) and history consistent with focal epilepsy
* At least two confirmed spontaneous seizures, at least 24 hours apart, in the 12 months prior to enrollment
* Complete AED history prior to enrollment (with approximate dates and doses) is available (exception can be made for AEDs taken for <1 week)
* Age =12 years and =60 years at time of seizure onset
* Age =12 years and =60 years at time of enrollment
* Treatment instituted not more than 4 months prior to enrollment
* One of the following:

1. Normal MRI with inter-ictal EEG showing focal abnormality (focal sharp waves or focal slowing)
2. Normal MRI and normal inter-ictal EEG, with clinical or electrographic seizure activity on ictal EEG
3. Definitive clinical history of recurrent seizures consistent with focal epilepsy, adjudicated by central reviewers, if normal MRI and normal EEG
4. Focal lesion (non-progressive) on MRI with normal EEG (acceptable focal lesions include MTS, FCD, single cavernoma, and AVMs that are not of large size and lack significant amounts of hemosiderin)
Minimum age
12 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Idiopathic or symptomatic generalized epilepsy
* Any epilepsy etiology that could produce significant gliosis or brain injury and would be likely to alter biomarkers. These include:

1. Epilepsy with an etiology occurring in the previous two years that would produce significant CNS injury (e.g., traumatic brain injury that involves direct disruption of brain tissue, stroke, encephalitis)
2. History of intracranial bleeding (e.g., subarachnoid, intraparenchymal)
* Identified genetic epilepsy syndrome
* Presence of moderate or greater developmental or cognitive delay prior to seizure onset (e.g., if an adolescent, not in self-contained classroom; if IQ is documented, should be > 70)
* History of chronic drug or alcohol abuse within the last 2 years
* IGE/focal epilepsy mixed syndromes
* Progressive neurological disorder (brain tumor, AD, PME, etc.)
* Major medical co-morbidities such as renal failure requiring dialysis, metastatic cancer, HIV, or significant liver or renal disease
* Autism Spectrum Disorder
* Seizures only during pregnancy
* History of previous or current significant psychiatric disorder that would interfere with conduct of the study

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2021
Sample size
Target
Accrual to date
Final
488
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Austin Hospital, University of Melbourne - Melbourne
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [3] 0 0
Prince of Wales Hospital, University of New South Wales - Sydney
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
NYU Langone Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Epilepsy Study Consortium
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
HEP is a five-year, prospective, observational study whose primary goal is to identify clinical characteristics and biomarkers predictive of disease outcome, progression, and treatment response in participants with newly treated focal epilepsy.
Trial website
https://clinicaltrials.gov/study/NCT02126774
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ruben Kuzniecky, MD
Address 0 0
New York University, Comprehensive Epilepsy Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02126774