NCT01338805

Brief Summary

This long-term extension study will assess the safety, tolerability and efficacy of BGG492 as adjunctive treatment in patients with partial onset seizures.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_2

Geographic Reach
6 countries

16 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2016

Enrollment Period

1.1 years

First QC Date

April 15, 2011

Last Update Submit

March 2, 2021

Conditions

Partial Onset Seizures

Keywords

Partial onset seizureseizure frequencynervous system diseasescentral nervous system diseasesCNSbrain diseasesneurologic manifestationsadjunctive treatmentAEDsantiepileptic drug

Outcome Measures

Primary Outcomes (1)

  • To evaluate the long-term safety and tolerability of BGG492 capsules during the maintenance period in patients suffering from partial onset seizures

    By measuring the number and percent of patients having any AE (advent event) by primary system organ class and/or preferred term. By laboratory, vital sign, and ECG data, summary statistics of values and change from baseline

    38 weeks

Secondary Outcomes (4)

  • To evaluate the efficacy over time by the change in partial seizure frequency original Baseline Period in the double-blind study CBGG492A2207 to the Open-label Extension Maintenance Phase.

    38 weeks

  • Responder rate: To evaluate the maintenance of efficacy by the change in responder rate and numbers of patients becoming seizure free from the original Baseline Period to the Open-label Extension Maintenance Phase.

    38 weeks

  • Seizure counts: To evaluate the maintenance of efficacy and safety as assessed in percent change of seizure frequency of BGG492 capsules from the original Baseline Period to the Open-label Extension Maintenance Phase.

    38 weeks

  • To evaluate long-term efficacy and safety by summarizing the number and percentage of patients who discontinue due to unsatisfactory therapeutic response effect and for all other reasons.

    30 weeks

Study Arms (1)

BGG492

EXPERIMENTAL

hard gelatin capsule for oral administration at 50 mg TID, 100 mg TID or 150 mg TID

Drug: BGG492

Interventions

BGG492DRUG
BGG492

Eligibility Criteria

Age18 Years - 66 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completed study CBGG492A2207, cooperated with the study procedures and did not experience persistent tolerability issues
  • Outpatients ≥ 45 kg (99 lb) of weight
  • Patient would like to continue BGG492 treatment and the investigator believes a reasonable benefit from the long-term administration of BGG492 may be expected
  • Treated with a stable dose of one or a maximum of three licensed Antiepileptic drugs (AEDs)and are known to take their medication(s) as directed
  • Will make themselves available for the study period and are able to record seizures and report adverse events themselves or have a caregiver who can record and report the events
  • Provided written informed consent before any extension assessment is performed

You may not qualify if:

  • Status epilepticus or seizure clusters occurring during study CBGG492A2207 or in the period between the end of study the double blind study and the start of study CBGG492A2212 for patients experiencing a treatment gap
  • Have been treated with:
  • Felbamate, unless treatment has been continuous for ≥ 2 years
  • Vigabatrin during the 26 weeks prior to the first dose of open-label medication in the extension study
  • Monoamine oxidase (MAO) inhibitors, tricyclic-antidepressants and narcotic analgesics
  • L-Dopa formulations
  • Use of concomitant medication that are potential inhibitors of Organic anion-transporting polypeptide (OATP) transporters
  • No physical examination changes suggestive of progressive neurological changes during Study CBGG492A2207
  • Used another investigational drug (other than BGG492) either at the time of enrollment in this extension study or within 5 half-lives prior to enrollment in this extension study
  • History of hypersensitivity to the study drug or to drugs of similar chemical classes (e.g. sulfonamides) or had multiple drug allergies or one or more severe drug reactions to an Antiepileptic drugs (AEDs), including dermatological reactions
  • Pregnant or nursing (lactating) women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Novartis Investigative Site

Tallahassee, Florida, 32308, United States

Location

Novartis Investigative Site

Hamilton, New Jersey, 08619, United States

Location

Novartis Investigative Site

Dallas, Texas, 75230, United States

Location

Novartis Investigative Site

Bernau, 16321, Germany

Location

Novartis Investigative Site

Bielefeld, 33617, Germany

Location

Novartis Investigative Site

Bonn, 53105, Germany

Location

Novartis Investigative Site

Kehl-Kork, 77694, Germany

Location

Novartis Investigative Site

Ulm, 89081, Germany

Location

Novartis Investigative Site

Budapest, 1096, Hungary

Location

Novartis Investigative Site

Kecskemét, 6000, Hungary

Location

Novartis Investigative Site

Szombathely, 9700, Hungary

Location

Novartis Investigative Site

Warsaw, 02-957, Poland

Location

Novartis Investigative Site

Banská Bystrica, 97517, Slovakia

Location

Novartis Investigative Site

Košice, 041 90, Slovakia

Location

Novartis Investigative Site

Seoul, Korea, 110 744, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 135-710, South Korea

Location

Related Links

MeSH Terms

Conditions

Nervous System DiseasesCentral Nervous System DiseasesBrain DiseasesNeurologic Manifestations

Interventions

selurampanel

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2011

First Posted

April 20, 2011

Study Start

June 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

March 5, 2021

Record last verified: 2016-03

Locations

DE(5)SL(2)HU(3)US(3)PL(1)KR(2)