Effect of BGG492 on EEG in Patients With Photosensitive Epilepsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00784212
First received: October 31, 2008
Last updated: February 11, 2013
Last verified: February 2013

October 31, 2008
February 11, 2013
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00784212 on ClinicalTrials.gov 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. ] [ Designated as safety issue: Yes ]
Outcome Measure: Safety and tolerability of BGG492 in patients with photosensitive epilepsy [ Time Frame: From Day 1 until Day 33 after treatment start. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
Not Provided
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.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00784212
CBGG492A2203, 2007-005418-38
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Principal Investigator: Novartis Novartis Investigator Site
Novartis
February 2013

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