Clinical trial NCT00887861: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seizures
Epilepsy
Keywords: epilepsy
seizure
monotherapy trials
partial seizure
Partial seizures and undergoing evaluation for epilepsy surgery
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-04-24
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: 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
timeFrame: 7 days
Secondary outcomes:
measure: 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.
timeFrame: 9 days
measure: Measure: To evaluate the safety and tolerability of investigational drug repeated dose over 9 days in patients with refractory partial seizures
timeFrame: 9 days
measure: Measure: To determine the plasma levels of investigational drug in patients with refractory partial seizures.
timeFrame: 9 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigator Site
city: Bielefeld
country: Germany
facility: Novartis Investigator Site
city: Bonn
country: Germany
facility: Novartis Investigator Site
city: Erlangen
country: Germany
facility: Novartis Investigator Site
city: Freiburg
country: Germany
facility: Novartis Investigator Site
city: Munich
country: Germany
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: