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A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02170077
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : August 12, 2014
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
The purpose of this study is to determine the efficacy of BIA 2 093 in the treatment of epileptic patients with refractory simple or complex partial seizures with or without secondary generalization.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: BIA 2-093 Drug: Placebo Phase 2

Detailed Description:

This clinical trial was performed as a multicentre, add-on, double-blind, randomised, placebo-controlled, phase II study. During the double-blind treatment phase (12 weeks) patients were assigned to three treatment groups receiving BIA 2 093 once daily (ODG - once-daily group), BIA 2 093 twice daily (TDG - twice-daily group) or placebo (PLG - placebo group), respectively. Daily doses of BIA 2 093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).

On completion of the 12-week double-blind treatment period, a 1-week tapering period was scheduled.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093 in Controlling Refractory Partial Seizures When Added to Ongoing Therapy
Study Start Date : April 2002
Actual Primary Completion Date : November 2002
Actual Study Completion Date : November 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
Experimental: ODG - once-daily group
BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).
Drug: BIA 2-093
BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route

Experimental: TDG - twice-daily group
BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).
Drug: BIA 2-093
BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route

Placebo Comparator: PLG - placebo group
placebo
Drug: Placebo
Placebo tablets administered orally




Primary Outcome Measures :
  1. The Percentage of Participants With a 50% or Greater Reduction in Seizure Frequency (Further Referred to as "Responders") in a Treatment Period Compared to the Baseline Period [ Time Frame: baseline, week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients aged 18-65 years
  • Patients with simple or complex partial seizures with or without secondary generalization since at least one year prior to randomisation visit
  • At least 4 seizures per month within the last 2 months prior to randomisation
  • Stable dose regimen of a maximum of two of the following AEDs: phenytoin, valproate, primidone, phenobarbital, lamotrigine, gabapentin, topiramate, clonazepam, during 2 months prior to randomisation
  • Electroencephalogram (EEG) findings not contradicting the epilepsy diagnosis (e.g., primarily generalized epilepsy)
  • Written informed consent.

Exclusion Criteria:

  • Patient with nervus vagus stimulation
  • Patient with primarily generalized seizures
  • Known progressive neurological disturbance
  • A history of status epilepticus within the past 3 months
  • Seizure of non-epileptic origin
  • Restricted legal competence and incapability to follow trial instructions
  • Major psychiatric disorders
  • Concurrent drug therapy with monoamine oxidase inhibitors or calcium channel blockers
  • Need of excluded concomitant medication (see section 9.4.6.2)
  • Use of oxcarbazepine or carbamazepine during the last 6 months before the randomisation visit
  • Known hypersensitivity to oxcarbazepine or carbamazepine, or its metabolites
  • Abuse of alcohol, drugs or medications
  • History of relevant cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, hematologic or oncology disorders
  • Second- or third-degree atrioventricular block not corrected with a pacemaker
  • Relevant laboratory abnormalities (e.g., Na+< 130 mmol/L, alanine (ALT) or aspartate (AST) transaminase >2.0 times the upper limit of normal, white blood cell (WBC) count <3000 cells/mm3)
  • Pregnancy, nursing or inadequate contraception in women of childbearing age (oral contraception should be combined with a barrier method)
  • Participation in other clinical trials within the last 2 months
  • History of non-compliance.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02170077


Locations
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Portugal
BIAL - Portela & Cª, S.A.
S. Mamede do Coronado, Portugal, 4045-457
Sponsors and Collaborators
Bial - Portela C S.A.

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02170077    
Other Study ID Numbers: BIA-2093-201
First Posted: June 23, 2014    Key Record Dates
Results First Posted: August 12, 2014
Last Update Posted: August 18, 2017
Last Verified: July 2017
Keywords provided by Bial - Portela C S.A.:
Epilepsy
BIA 2-093
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Eslicarbazepine acetate
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action