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

NCT ID: NCT00887861

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-08-31

Brief Summary

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

Conditions

Seizures; Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BGG492

Group Type: EXPERIMENTAL

Investigational new drug, company code: BGG492

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Investigational new drug, company code: BGG492

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Absence of evolving space-occupying lesions or progressive neurological diseases.

3. Have normal vital signs (systolic and diastolic blood pressure and pulse rate)

4. All female subjects must have negative pregnancy test results

5. 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

1. A history of frequent and/or severe status epilepticus (i.e. requiring intensive care unit treatment).

2. Current treatment with phenobarbital, primidone or zonisamide (these drugs would have to be completely washed out before study start)

3. Having discontinued chronic benzodiazepine and barbiturate therapy within 30 days prior to the study start

4. Having electrodes implanted in the brain.

5. 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.

6. 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

7. Having a significant illness other than epilepsy within two (2) weeks prior to initial dosing.

8. Having recent (within the last three (3) years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigator Site

Berlin, , Germany

Novartis Investigator Site

Bielefeld, , Germany

Novartis Investigator Site

Bonn, , Germany

Novartis Investigator Site

Erlangen, , Germany

Novartis Investigator Site

Freiburg im Breisgau, , Germany

Novartis Investigator Site

Munich, , Germany

Countries

Germany

Other Identifiers

EudraCT 2008-005065-64

Identifier Type: -

Identifier Source: secondary_id

CBGG492A2202

Identifier Type: -

Identifier Source: org_study_id