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

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

Tracking Information

• First Submitted Date: April 23, 2009
• First Posted Date: April 24, 2009
• Last Update Posted Date: March 21, 2017
• Study Start Date: March 2009
• Actual Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy of BGG492 in Individuals With Refractory Partial Seizures Undergoing Inpatient Evaluation for Epilepsy Surgery
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Seizures
• Epilepsy

Intervention

• Drug: Investigational new drug, company code: BGG492
• Drug: Placebo

Study Arms

• Experimental: BGG492
  Intervention: Drug: Investigational new drug, company code: BGG492
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 16, 2010): 37
• Original Estimated Enrollment (submitted: April 23, 2009): 45
• Actual Study Completion Date: August 2010
• Actual Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

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).

Other protocol-defined inclusion/exclusion criteria may apply

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00887861
• Other Study ID Numbers: CBGG492A2202; EudraCT 2008-005065-64
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Novartis
• Original Responsible Party: External Affairs, Organization: Novartis Pharmaceuticals
• Current Study Sponsor: Novartis
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: March 2017