Effect of BGG492 on EEG in Patients With Photosensitive Epilepsy

Photosensitive Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784212
• Other study ID #: CBGG492A2203
• Secondary ID: 2007-005418-38
• Status: Completed
• Phase: Phase 2
• First received: October 31, 2008
• Last updated: September 21, 2016
• Start date: October 2008
• Est. completion date: September 2010

Study information

• Verified date: September 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• diagnosis of photosensitive epilepsy

Exclusion Criteria:

• inconsistent photoparoxysmal response when stimulated by photic stimulation

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Photosensitive Epilepsy

Intervention

Drug:
• BGG492

• BGG492

• Placebo

Locations

Country	Name	City	State
Germany	Novartis Investigator Site	Bielefeld
Germany	Novartis Investigator Site	Kehl-Kork
Germany	Novartis Investigator Site	Kiel
Germany	Novartis Investigator Site	Radeberg

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome Measure: Photoparoxysmal response (PPR) and standardized photoparoxysmal response (SPR) determined by EEG on all treatment days.		Days 1, 2 and 3	No
Secondary	Outcome Measure: Safety and tolerability of BGG492 in patients with photosensitive epilepsy		From Day 1 until Day 33 after treatment start.	Yes