NCT00887861

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

1.4 years

First QC Date

April 23, 2009

Last Update Submit

March 17, 2017

Conditions

SeizuresEpilepsy

Keywords

epilepsyseizuremonotherapy trialspartial seizurePartial seizures and undergoing evaluation for epilepsy surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • Measure: To evaluate the safety and tolerability of investigational drug repeated dose over 9 days in patients with refractory partial seizures

    9 days

  • Measure: To determine the plasma levels of investigational drug in patients with refractory partial seizures.

    9 days

Study Arms (2)

BGG492

EXPERIMENTAL
Drug: Investigational new drug, company code: BGG492

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Investigational new drug, company code: BGG492DRUG
BGG492
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Absence of evolving space-occupying lesions or progressive neurological diseases.
  • Have normal vital signs (systolic and diastolic blood pressure and pulse rate)
  • All female subjects must have negative pregnancy test results
  • 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.

You may not qualify if:

  • A history of frequent and/or severe status epilepticus (i.e. requiring intensive care unit treatment).
  • Current treatment with phenobarbital, primidone or zonisamide (these drugs would have to be completely washed out before study start)
  • Having discontinued chronic benzodiazepine and barbiturate therapy within 30 days prior to the study start
  • Having electrodes implanted in the brain.
  • 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.
  • 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
  • Having a significant illness other than epilepsy within two (2) weeks prior to initial dosing.
  • Having recent (within the last three (3) years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Novartis Investigator Site

Berlin, Germany

Location

Novartis Investigator Site

Bielefeld, Germany

Location

Novartis Investigator Site

Bonn, Germany

Location

Novartis Investigator Site

Erlangen, Germany

Location

Novartis Investigator Site

Freiburg im Breisgau, Germany

Location

Novartis Investigator Site

Munich, Germany

Location

MeSH Terms

Conditions

SeizuresEpilepsy

Interventions

Drugs, Investigational

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2009

First Posted

April 24, 2009

Study Start

March 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

March 21, 2017

Record last verified: 2017-03

Locations

DE(6)