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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887861
• Other study ID #: CBGG492A2202
• Secondary ID: EudraCT 2008-005
• Status: Completed
• Phase: Phase 2
• First received: April 23, 2009
• Last updated: March 17, 2017
• Start date: March 2009
• Est. completion date: August 2010

Study information

• Verified date: March 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Drug:
• Investigational new drug, company code: BGG492

• Placebo

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		7 days
Secondary	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.		9 days
Secondary	Measure: To evaluate the safety and tolerability of investigational drug repeated dose over 9 days in patients with refractory partial seizures		9 days
Secondary	Measure: To determine the plasma levels of investigational drug in patients with refractory partial seizures.		9 days

External Links

•   Results for CBGG492A2202 from Novartis Clinical Trials Website