NCT02144792

Brief Summary

The major hypothesis explaining drug resistance is overexpression of p-glycoprotein at the target lesion. Based on several studies, p-glycoprotein (P-gp) has an important role in neurologic diseases, especially in drug resistant epilepsy. But there is no surrogate marker that can quantify the expression of P-gp because of the difficulty in measuring substances in the neurologic system and the lack of clinical trials. Here, the investigators use a novel non-invasive \[11C\] -verapamil Brain PET and SPAM analytic method as a surrogate marker for quantifying the expression of p-glycoprotein.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2014

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

April 22, 2014

Last Update Submit

May 19, 2014

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Measured Asymmetric index[(SUV in Right regions - SUV in Left regions)/(SUV in Right regions+ SUV in left regions)] in all three groups

    Comparing with Asymmetry index in each groups

    first visit day

Secondary Outcomes (1)

  • Number of patients with side effect of cyclosporine and [11C]-verapamil PET

    During and after the drug injection, During and after the PET Scan [first visit day]

Study Arms (3)

Control group (healthy persons)

ACTIVE COMPARATOR

Normal controls take a \[11C\] -verapamil PET scan. While P-gp inhibitor (Cyclosporin A, 2.5mg/kg/hr during 2hours, intravenous) is infused, PET scans were done using \[11C\] -verapamil, a substrate of P-gp.

Drug: [11C] -verapamil PET

Patients with drug-resistant epilesy

ACTIVE COMPARATOR

Patients with drug-resistant epilepsy take a \[11C\] -verapamil PET scan. While P-gp inhibitor (Cyclosporin A, 2.5mg/kg/hr during 2hours, intravenous) is infused, PET scans were done using \[11C\] -verapamil, a substrate of P-gp.

Drug: [11C] -verapamil PET

Patients with drug-sensitive epilepsy

ACTIVE COMPARATOR

Patients with drug-sensitive epilepsy take a \[11C\] -verapamil PET scan. While P-gp inhibitor (Cyclosporin A, 2.5mg/kg/hr during 2hours, intravenous) is infused, PET scans were done using \[11C\] -verapamil, a substrate of P-gp.

Drug: [11C] -verapamil PET

Interventions

[11C] -verapamil PETDRUG

While P-gp inhibitor (Cyclosporin A, 2.5mg/kg/hr during 2hours, intravenous) is infused, PET scans were done using \[11C\] -verapamil, a substrate of P-gp.

Also known as: VPM PET
Control group (healthy persons)Patients with drug-resistant epilesyPatients with drug-sensitive epilepsy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy controls ( age range 20-45 years)
  • Patient age (\> 15), diagnose as epilepsy

You may not qualify if:

  • Subjects who take medicines that affect on the function of p-glycoproteins
  • Pregnancy or subject who feed the breast milk
  • Subjects who had severe renal disease or liver disease
  • Subjects who need treated by immunosuppressant or take immunosuppressant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Sang Kun Lee, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Kun Lee, MD, PhD

CONTACT

sangkun2923@gmail.com

Jung-Won Shin, MD

CONTACT

limitsum@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Seoul National University Hospital

Study Record Dates

First Submitted

April 22, 2014

First Posted

May 22, 2014

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Study Completion

December 1, 2014

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

KR(1)