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Efficacy of BGG492 in Individuals With Refractory Partial Seizures Undergoing Inpatient Evaluation for Epilepsy Surgery

Primary Purpose

Seizures, Epilepsy

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Investigational new drug, company code: BGG492

Placebo

About this trial

This is an interventional treatment trial for Seizures focused on measuring epilepsy, seizure, monotherapy trials, partial seizure, Partial seizures and undergoing evaluation for epilepsy surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A diagnosis of partial seizures (with or without secondary generalization) and undergoing an evaluation for epilepsy surgery, based on the classification of the International League Against Epilepsy (ILAE), as modified in 1981.
Absence of evolving space-occupying lesions or progressive neurological diseases.
Have normal vital signs (systolic and diastolic blood pressure and pulse rate)
All female subjects must have negative pregnancy test results
Subjects must weigh at least 50 kg to participate in this study and must have a body mass index (BMI) within the range of 18 to 35.

Exclusion Criteria:

A history of frequent and/or severe status epilepticus (i.e. requiring intensive care unit treatment).
Current treatment with phenobarbital, primidone or zonisamide (these drugs would have to be completely washed out before study start)
Having discontinued chronic benzodiazepine and barbiturate therapy within 30 days prior to the study start
Having electrodes implanted in the brain.
Having evidence on physical examination, or a history of any medically significant thyroid, cardiac, respiratory, hepatic, gastrointestinal, renal, hematologic, oncologic, psychiatric or progressive neurological disorder, requiring current medical intervention/therapy likely to have a significant impact on the outcome of this study.
With any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs, e.g. GI surgery and/or pancreatic or liver disease
Having a significant illness other than epilepsy within two (2) weeks prior to initial dosing.
Having recent (within the last three (3) years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc).

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

Novartis Investigator Site
Novartis Investigator Site
Novartis Investigator Site
Novartis Investigator Site
Novartis Investigator Site
Novartis Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BGG492

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Measure: An efficacy of investigation drug versus Placebo in reducing the seizure rate when administered orally for up to 7days as monotherapy in patients with refractory partial seizures who are undergoing an inpatient evaluation for epilepsy

Secondary Outcome Measures

Measure:An efficacy of investing. drug vs. Pcb in reducing the seizure rate when administered orally for up to 9days (during titration monotherapy)in pts. with refractory partial seizures who are undergoing an inpatient evaluation for epilepsy surgery.

Measure: To evaluate the safety and tolerability of investigational drug repeated dose over 9 days in patients with refractory partial seizures

Measure: To determine the plasma levels of investigational drug in patients with refractory partial seizures.

Full Information

NCT ID

NCT00887861

First Posted

April 23, 2009

Last Updated

March 17, 2017

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00887861

Brief Title

Efficacy of BGG492 in Individuals With Refractory Partial Seizures Undergoing Inpatient Evaluation for Epilepsy Surgery

Official Title

A Multicenter, Double-blind, Randomized, Placebo-controlled, Two-arm Parallel-group Study of BGG492 as Monotherapy in Individuals With Refractory Partial Seizures Undergoing Inpatient Evaluation for Epilepsy Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will asses the safety and efficacy of BGG492 in reducing the seizure rate in therapy-refractory partial seizures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seizures, Epilepsy

Keywords

epilepsy, seizure, monotherapy trials, partial seizure, Partial seizures and undergoing evaluation for epilepsy surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BGG492

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Investigational new drug, company code: BGG492

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Time Frame

9 days

Title

Measure: To evaluate the safety and tolerability of investigational drug repeated dose over 9 days in patients with refractory partial seizures

Time Frame

9 days

Title

Measure: To determine the plasma levels of investigational drug in patients with refractory partial seizures.

Time Frame

9 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A diagnosis of partial seizures (with or without secondary generalization) and undergoing an evaluation for epilepsy surgery, based on the classification of the International League Against Epilepsy (ILAE), as modified in 1981. Absence of evolving space-occupying lesions or progressive neurological diseases. Have normal vital signs (systolic and diastolic blood pressure and pulse rate) All female subjects must have negative pregnancy test results Subjects must weigh at least 50 kg to participate in this study and must have a body mass index (BMI) within the range of 18 to 35. Exclusion Criteria: A history of frequent and/or severe status epilepticus (i.e. requiring intensive care unit treatment). Current treatment with phenobarbital, primidone or zonisamide (these drugs would have to be completely washed out before study start) Having discontinued chronic benzodiazepine and barbiturate therapy within 30 days prior to the study start Having electrodes implanted in the brain. Having evidence on physical examination, or a history of any medically significant thyroid, cardiac, respiratory, hepatic, gastrointestinal, renal, hematologic, oncologic, psychiatric or progressive neurological disorder, requiring current medical intervention/therapy likely to have a significant impact on the outcome of this study. With any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs, e.g. GI surgery and/or pancreatic or liver disease Having a significant illness other than epilepsy within two (2) weeks prior to initial dosing. Having recent (within the last three (3) years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc). Other protocol-defined inclusion/exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigator Site

City

Berlin

Country

Germany

Facility Name

Novartis Investigator Site

City

Bielefeld

Country

Germany

Facility Name

Novartis Investigator Site

City

Bonn

Country

Germany

Facility Name

Novartis Investigator Site

City

Erlangen

Country

Germany

Facility Name

Novartis Investigator Site

City

Freiburg

Country

Germany

Facility Name

Novartis Investigator Site

City

Munich

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Efficacy of BGG492 in Individuals With Refractory Partial Seizures Undergoing Inpatient Evaluation for Epilepsy Surgery

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