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

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.
 
ClinicalTrials.gov Identifier: NCT00887861
Recruitment Status : Completed
First Posted : April 24, 2009
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

Tracking Information
First Submitted Date  ICMJE April 23, 2009
First Posted Date  ICMJE April 24, 2009
Last Update Posted Date March 21, 2017
Study Start Date  ICMJE March 2009
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of BGG492 in Individuals With Refractory Partial Seizures Undergoing Inpatient Evaluation for Epilepsy Surgery
Official Title  ICMJE 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
Brief Summary This study will asses the safety and efficacy of BGG492 in reducing the seizure rate in therapy-refractory partial seizures.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Seizures
  • Epilepsy
Intervention  ICMJE
  • Drug: Investigational new drug, company code: BGG492
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: BGG492
    Intervention: Drug: Investigational new drug, company code: BGG492
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2010)
37
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2009)
45
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00887861
Other Study ID Numbers  ICMJE CBGG492A2202
EudraCT 2008-005065-64
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Novartis
Original Responsible Party External Affairs, Organization: Novartis Pharmaceuticals
Current Study Sponsor  ICMJE Novartis
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP