Effect of BGG492 on EEG in Patients With Photosensitive Epilepsy

NCT ID: NCT00784212

Last Updated: 2016-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-09-30

Brief Summary

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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

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Conditions

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Photosensitive Epilepsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cohort 1

Group Type EXPERIMENTAL

BGG492

Intervention Type DRUG

Cohort II

Group Type EXPERIMENTAL

BGG492

Intervention Type DRUG

Cohort III

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Interventions

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BGG492

Intervention Type DRUG

BGG492

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* diagnosis of photosensitive epilepsy

Exclusion Criteria

\- inconsistent photoparoxysmal response when stimulated by photic stimulation
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis

Role: PRINCIPAL_INVESTIGATOR

Novartis Investigator Site

Locations

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Novartis Investigator Site

Bielefeld, , Germany

Site Status

Novartis Investigator Site

Kehl-Kork, , Germany

Site Status

Novartis Investigator Site

Kiel, , Germany

Site Status

Novartis Investigator Site

Radeberg, , Germany

Site Status

Countries

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Germany

References

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Kasteleijn-Nolst Trenite 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.

Reference Type DERIVED
PMID: 25963722 (View on PubMed)

Other Identifiers

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2007-005418-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CBGG492A2203

Identifier Type: -

Identifier Source: org_study_id

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