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Effect of BGG492 on EEG in Patients With Photosensitive Epilepsy

Primary Purpose

Photosensitive Epilepsy

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

BGG492

Placebo

About this trial

This is an interventional treatment trial for Photosensitive Epilepsy focused on measuring Photosensitive Epilepsy, photic stimulation, electroencephalogram

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

diagnosis of photosensitive epilepsy

Exclusion Criteria:

- inconsistent photoparoxysmal response when stimulated by photic stimulation

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

Novartis Investigator Site
Novartis Investigator Site
Novartis Investigator Site
Novartis Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cohort 1

Cohort II

Cohort III

Arm Description

Outcomes

Primary Outcome Measures

Outcome Measure: Photoparoxysmal response (PPR) and standardized photoparoxysmal response (SPR) determined by EEG on all treatment days.

Secondary Outcome Measures

Outcome Measure: Safety and tolerability of BGG492 in patients with photosensitive epilepsy

Full Information

NCT ID

NCT00784212

First Posted

October 31, 2008

Last Updated

September 21, 2016

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00784212

Brief Title

Effect of BGG492 on EEG in Patients With Photosensitive Epilepsy

Official Title

A Multicenter, Single-blind, Within-subject, Placebo-controlled Proof of Concept Study to Assess the Effect of Single Oral Doses of BGG492 on the Photoparoxysmal EEG Response in Patients With Photosensitive Epilepsy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

This study will evaluate the efficacy of BGG492 in reducing the sensitivity to flashing lights of patients with photosensitive epilepsy, using EEG as a readout.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Photosensitive Epilepsy

Keywords

Photosensitive Epilepsy, photic stimulation, electroencephalogram

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Title

Cohort II

Arm Type

Experimental

Arm Title

Cohort III

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

BGG492

Intervention Type

Drug

Intervention Name(s)

BGG492

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Outcome Measure: Photoparoxysmal response (PPR) and standardized photoparoxysmal response (SPR) determined by EEG on all treatment days.

Time Frame

Days 1, 2 and 3

Secondary Outcome Measure Information:

Title

Outcome Measure: Safety and tolerability of BGG492 in patients with photosensitive epilepsy

Time Frame

From Day 1 until Day 33 after treatment start.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: diagnosis of photosensitive epilepsy Exclusion Criteria: - inconsistent photoparoxysmal response when stimulated by photic stimulation Other protocol-defined inclusion/exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis

Organizational Affiliation

Novartis Investigator Site

Official's Role

Principal Investigator

Facility Information:

Facility Name

Novartis Investigator Site

City

Bielefeld

Country

Germany

Facility Name

Novartis Investigator Site

City

Kehl-Kork

Country

Germany

Facility Name

Novartis Investigator Site

City

Kiel

Country

Germany

Facility Name

Novartis Investigator Site

City

Radeberg

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

25963722

Citation

Kasteleijn-Nolst Trenite D, Brandt C, Mayer T, Rosenow F, Schmidt B, Steinhoff BJ, Gardin A, Imbert G, Johns D, Sagkriotis A, Kucher K. Dose-dependent suppression of human photoparoxysmal response with the competitive AMPA/kainate receptor antagonist BGG492: Clear PK/PD relationship. Epilepsia. 2015 Jun;56(6):924-32. doi: 10.1111/epi.13008. Epub 2015 May 11.

Results Reference

derived

Learn more about this trial

Effect of BGG492 on EEG in Patients With Photosensitive Epilepsy

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