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
  Purpose

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.


Condition Intervention Phase
Photosensitive Epilepsy
Drug: BGG492
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 13
Study Start Date: October 2008
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 Drug: BGG492
Experimental: Cohort II Drug: BGG492
Experimental: Cohort III Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of photosensitive epilepsy

Exclusion Criteria:

- inconsistent photoparoxysmal response when stimulated by photic stimulation

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784212

Locations
Germany
Novartis Investigator Site
Bielefeld, Germany
Novartis Investigator Site
Kehl-Kork, Germany
Novartis Investigator Site
Kiel, Germany
Novartis Investigator Site
Radeberg, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Principal Investigator: Novartis Novartis Investigator Site
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00784212     History of Changes
Other Study ID Numbers: CBGG492A2203, 2007-005418-38
Study First Received: October 31, 2008
Last Updated: February 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by Novartis:
Photosensitive Epilepsy, photic stimulation, electroencephalogram

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Reflex
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 31, 2014