Text Size

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
History of Changes
  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:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

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
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 June 17, 2013