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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:
ClinicalTrials.gov Identifier:
NCT00887861
First Posted: April 24, 2009
Last Update Posted: March 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  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 (Participant, 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:


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 ]

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

Enrollment: 37
Study Start Date: March 2009
Study Completion Date: August 2010
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00887861     History of Changes
Other Study ID Numbers: CBGG492A2202
EudraCT 2008-005065-64
First Submitted: April 23, 2009
First Posted: April 24, 2009
Last Update Posted: March 21, 2017
Last Verified: March 2017

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