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Completed

NCT Number: NCT01338805

Phase II BGG492 Capsule Extension for Partial Epilepsy

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

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Key information

Conditions

Partial Onset Seizures Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Bernau, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

BGG492

Drug

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

    Time frame: 38 weeks

    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

Secondary outcomes

  1. 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.

    Time frame: 38 weeks

  2. 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.

    Time frame: 38 weeks

  3. 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.

    Time frame: 38 weeks

  4. 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.

    Time frame: 30 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multicenter, Open-label, Follow-up Study to Evaluate the Long-term Safety and Tolerability of BGG492 TID as Adjunctive Therapy in Patients With Partial Onset Seizures Completing Double-blind, Placebo-controlled Study CBGG492A2207 or CBGG492A2211

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 20, 2011
Registry last updated
Mar 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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