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Completed

NCT Number: NCT01147003

Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures

This study will assess the efficacy and safety 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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Sofia, Bulgaria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Outpatients ≥ 50 kg (110 lb) of weight.
  • A diagnosis of epilepsy (≥ 2 years prior to screening) with partial seizures with or without secondarily generalized seizures.
  • Uncontrolled partial seizures despite having been treated with at least two different antiepileptic drugs (AEDs) within the last 2 years prior to screening.
  • At least 4 partial seizures during the 4-week baseline period and at least 4 partial seizures during the 4 weeks prior to the baseline period.
  • Cohort 1 patients must be receiving stable treatment with 1 or a maximum of 2 AEDs.Cohort 2 patients must be receiving stable treatment with 1, 2, or 3 AEDs.

Exclusion criteria

  • Presence of only non-motor simple partial seizures.
  • History of psychogenic seizures.
  • Absences, myoclonic seizures e.g. in the context of primary generalized epilepsy.
  • Previous history of Lennox-Gastaut syndrome.
  • Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization.
  • Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Investigational new drug, company code: BGG492

Drug

Placebo

Drug

Primary outcomes

  1. To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period.

    Time frame: 28 days

Secondary outcomes

  1. To evaluate the efficacy of BGG492 compared to placebo as a change in seizure frequency from baseline period to maintenance period.

    Time frame: 28 days

  2. Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.

    Time frame: 28 days

  3. Safety and tolerability of BGG492 compared to placebo.

    Time frame: 12 weeks

  4. Pharmacokinetic profile of BGG492

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study Examining Seizure Frequency of BGG492 Capsules as Adjunctive Treatment in Patients With Partial Onset Seizures

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 22, 2010
Registry last updated
Dec 17, 2020

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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