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Effect of BGG492 on EEG in Patients With Photosensitive Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00784212
Recruitment Status : Completed
First Posted : November 2, 2008
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE October 31, 2008
First Posted Date  ICMJE November 2, 2008
Last Update Posted Date September 23, 2016
Study Start Date  ICMJE October 2008
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2008)
Outcome Measure: Photoparoxysmal response (PPR) and standardized photoparoxysmal response (SPR) determined by EEG on all treatment days. [ Time Frame: Days 1, 2 and 3 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2008)
Outcome Measure: Safety and tolerability of BGG492 in patients with photosensitive epilepsy [ Time Frame: From Day 1 until Day 33 after treatment start. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of BGG492 on EEG in Patients With Photosensitive Epilepsy
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Photosensitive Epilepsy
Intervention  ICMJE
  • Drug: BGG492
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Cohort 1
    Intervention: Drug: BGG492
  • Experimental: Cohort II
    Intervention: Drug: BGG492
  • Experimental: Cohort III
    Intervention: Drug: Placebo
Publications * Kasteleijn-Nolst Trenité D, Brandt C, Mayer T, Rosenow F, Schmidt B, Steinhoff BJ, Gardin A, Imbert G, Johns D, Sagkriotis A, Kucher K. Dose-dependent suppression of human photoparoxysmal response with the competitive AMPA/kainate receptor antagonist BGG492: Clear PK/PD relationship. Epilepsia. 2015 Jun;56(6):924-32. doi: 10.1111/epi.13008. Epub 2015 May 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2011)
13
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2008)
26
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diagnosis of photosensitive epilepsy

Exclusion Criteria:

- inconsistent photoparoxysmal response when stimulated by photic stimulation

Other protocol-defined inclusion/exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00784212
Other Study ID Numbers  ICMJE CBGG492A2203
2007-005418-38 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Novartis Novartis Investigator Site
PRS Account Novartis
Verification Date September 2016

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