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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00887861
First received: April 23, 2009
Last updated: February 22, 2011
Last verified: February 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Seizures
Epilepsy
 Drug: Investigational new drug, company code: BGG492
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by Novartis:

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 [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 9 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Measure: To determine the plasma levels of investigational drug in patients with refractory partial seizures. [ Time Frame: 9 days ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: March 2009
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BGG492 Drug: Investigational new drug, company code: BGG492
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887861

Locations
Germany
Novartis Investigator Site
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
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Organization: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00887861     History of Changes
Other Study ID Numbers: CBGG492A2202, EudraCT 2008-005065-64
Study First Received: April 23, 2009
Last Updated: February 22, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
epilepsy
seizure
monotherapy trials
partial seizure
Partial seizures and undergoing evaluation for epilepsy surgery

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013