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

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

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

Study Overview

• Status: Completed
• Conditions: Epilepsy; Seizures
• Intervention / Treatment: Drug: Placebo; Drug: Investigational new drug, company code: BGG492

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Novartis Investigator Site
  • Bielefeld, Germany
    • Novartis Investigator Site
  • Bonn, Germany
    • Novartis Investigator Site
  • Erlangen, Germany
    • Novartis Investigator Site
  • Freiburg, Germany
    • Novartis Investigator Site
  • Munich, Germany
    • Novartis Investigator Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: BGG492	Drug: Investigational new drug, company code: BGG492

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	9 days
Measure: To evaluate the safety and tolerability of investigational drug repeated dose over 9 days in patients with refractory partial seizures	9 days
Measure: To determine the plasma levels of investigational drug in patients with refractory partial seizures.	9 days

Collaborators and Investigators

• Sponsor: Novartis

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: April 23, 2009
• First Submitted That Met QC Criteria: April 23, 2009
• First Posted (Estimate): April 24, 2009

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 17, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: epilepsy; partial seizure; seizure; monotherapy trials; Partial seizures and undergoing evaluation for epilepsy surgery
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures
• Other Study ID Numbers: CBGG492A2202; EudraCT 2008-005065-64