Effect of BGG492 on EEG in Patients With Photosensitive Epilepsy

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00784212
Recruitment Status : Completed
First Posted : November 3, 2008
Last Update Posted : September 23, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

October 31, 2008
November 3, 2008
September 23, 2016
October 2008
September 2010   (Final data collection date for primary outcome measure)
Outcome Measure: Photoparoxysmal response (PPR) and standardized photoparoxysmal response (SPR) determined by EEG on all treatment days. [ Time Frame: Days 1, 2 and 3 ]
Same as current
Complete list of historical versions of study NCT00784212 on Archive Site
Outcome Measure: Safety and tolerability of BGG492 in patients with photosensitive epilepsy [ Time Frame: From Day 1 until Day 33 after treatment start. ]
Same as current
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Effect of BGG492 on EEG in Patients With Photosensitive Epilepsy
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
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.
Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Photosensitive Epilepsy
  • Drug: BGG492
  • Drug: Placebo
  • Experimental: Cohort 1
    Intervention: Drug: BGG492
  • Experimental: Cohort II
    Intervention: Drug: BGG492
  • Experimental: Cohort III
    Intervention: Drug: Placebo
Kasteleijn-Nolst Trenité 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2010
September 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis of photosensitive epilepsy

Exclusion Criteria:

- inconsistent photoparoxysmal response when stimulated by photic stimulation

Other protocol-defined inclusion/exclusion criteria may apply.

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
2007-005418-38 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Principal Investigator: Novartis Novartis Investigator Site
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP