NCT Number: NCT00784212
Effect of BGG492 on EEG 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.
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Novartis Investigator Site, Bielefeld, Germany
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- diagnosis of photosensitive epilepsy
Exclusion criteria
- inconsistent photoparoxysmal response when stimulated by photic stimulation
Other protocol-defined inclusion/exclusion criteria may apply.
Treatment and study plan
Placebo
DrugPrimary outcomes
-
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 outcomes
-
Outcome Measure: Safety and tolerability of BGG492 in patients with photosensitive epilepsy
Time frame: From Day 1 until Day 33 after treatment start.
Sponsors and collaborators
Lead sponsor
Novartis Pharmaceuticals
Industry
Registry information
Official study 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
Important dates
- Study start
- 2008
- Primary completion
- 2010
- Study completion
- 2010
- First posted
- Nov 3, 2008
- Registry last updated
- Sep 23, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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