NCT00784212

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

4 active sites

Status
completed

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

October 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

1.9 years

First QC Date

October 31, 2008

Last Update Submit

September 21, 2016

Conditions

Photosensitive Epilepsy

Keywords

Photosensitive Epilepsy, photic stimulation, electroencephalogram

Outcome Measures

Primary Outcomes (1)

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

    Days 1, 2 and 3

Secondary Outcomes (1)

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

    From Day 1 until Day 33 after treatment start.

Study Arms (3)

Cohort 1

EXPERIMENTAL
Drug: BGG492

Cohort II

EXPERIMENTAL
Drug: BGG492

Cohort III

EXPERIMENTAL
Drug: Placebo

Interventions

BGG492DRUG
Cohort 1
PlaceboDRUG
Cohort III

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of photosensitive epilepsy

You may not qualify if:

  • \- inconsistent photoparoxysmal response when stimulated by photic stimulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novartis Investigator Site

Bielefeld, Germany

Location

Novartis Investigator Site

Kehl-Kork, Germany

Location

Novartis Investigator Site

Kiel, Germany

Location

Novartis Investigator Site

Radeberg, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25963722DERIVED

MeSH Terms

Conditions

Epilepsy, Reflex

Interventions

selurampanel

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Novartis

    Novartis Investigator Site

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2008

First Posted

November 3, 2008

Study Start

October 1, 2008

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

DE(4)