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

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 2
Locations
Portugal
Study Type
Interventional
Intervention
BIA 2-093
Placebo
Sponsored by
Bial - Portela C S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, BIA 2-093

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • BIAL - Portela & Cª, S.A.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ODG - once-daily group

TDG - twice-daily group

PLG - placebo group

Arm Description

BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).

BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).

placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 20, 2014
Last Updated
July 11, 2017
Sponsor
Bial - Portela C S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02170077
Brief Title
A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093
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 Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
November 2002 (Actual)
Study Completion Date
November 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bial - Portela C S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, BIA 2-093

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ODG - once-daily group
Arm Type
Experimental
Arm Description
BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).
Arm Title
TDG - twice-daily group
Arm Type
Experimental
Arm Description
BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).
Arm Title
PLG - placebo group
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
BIA 2-093
Intervention Description
BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets administered orally
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
BIAL - Portela & Cª, S.A.
City
S. Mamede do Coronado
ZIP/Postal Code
4045-457
Country
Portugal

12. IPD Sharing Statement

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

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