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Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Phenobarbital
Placebo tablet
Sponsored by
West-Ward Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring partial onset seizures

Eligibility Criteria

17 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • participants from 17 to 70 years old;
  • history of Type I partial onset seizures (complex or simple with motor symptoms only);
  • participants must have had electroencephalogram (EEG), magnetic resonance imaging (MRI) or computed tomography (CT) with results consistent with diagnosis of partial-onset seizures;
  • participants having at least eight Type I partial onset seizures during 8-week baseline period;
  • participants being uncontrolled while treated by 1 to 3 permitted concomitant anti-epileptic drug (AED) and/or Vagus Nerve Stimulation (VNS);
  • participant has been on a stable dose of their current anti-epileptic treatment regime

Exclusion Criteria:

  • currently taking phenobarbital or primidone;
  • currently taking felbamate or vigabatrin;
  • history of prior allergic reaction to phenobarbital;
  • history of psychogenic seizures;
  • history or presence of status epilepticus;
  • history or presence of seizures occurring only in clusters;
  • participant taking any drug with possible Central Nervous System (CNS) effects except if stable from 1 month prior Visit 1;
  • history of cerebrovascular accident (CVA) or transient ischemic attack (TIA);
  • presence of any sign suggesting rapidly progressing brain disorder or brain tumor;
  • presence of unstable arteriovenous malformations, meningiomas or other benign tumors;
  • history of porphyria;
  • presence of clinically significant findings on physical exam, vital signs, electrocardiogram (ECG) or safety lab assessments, including renal or hepatic insufficiency;
  • history of alcohol or drug abuse within the year prior to screening;
  • participant who is known to be non-compliant;
  • participant who is male or female who refuses to use an acceptable form of contraception;
  • female who is pregnant or lactating or intends to become pregnant;
  • participant who has taken part in any investigational device or product within 2 months prior to the screening visit

Sites / Locations

  • Bluegrass Epilepsy Research
  • Lynn Health Science Institute
  • Centro Neurodiagnostico
  • Hospital Del Maestro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

60 mg group

100 mg group

Arm Description

placebo tablets

Patients titrated to 60mg phenobarbital for maintenance period, then titrated down.

Patients titrated to 100mg phenobarbital maintenance period, then titrated down

Outcomes

Primary Outcome Measures

Evaluate the efficacy of OD administration of 60 mg and 100 mg phenobarbital in reduction of seizure frequency
determination of partial onset seizure frequency per week over the treatment period comparison of average change in weekly seizure rate from baseline and maintenance period

Secondary Outcome Measures

Confirm the dose response relationship of 60 mg and 100 mg phenobarbital doses
Assess the effects of phenobarbital on Type I seizures
seizure freedom rate percent reduction for partial onset seizure responder rate reduction of seizure frequency
Assess the safety of phenobarbital
overview of adverse events in study summary of adverse events in study by severity, seriousness, relationship to study drug, action taken, outcome, treatment summary of serious adverse events
Assess the tolerability of phenobarbital

Full Information

First Posted
January 20, 2011
Last Updated
November 9, 2017
Sponsor
West-Ward Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01284556
Brief Title
Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures
Official Title
An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Phenobarbital as Adjunctive Therapy in Participants (> or = 17 to 70 Years Old) With Partial Onset Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West-Ward Pharmaceutical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary: - to evaluate the efficacy of phenobarbital in reducing seizure frequency. Secondary: to confirm dose response relationship, to assess the effects on Type I seizures, to assess the safety of phenobarbital to assess the drug tolerability.
Detailed Description
Primary: -to evaluate the efficacy of once daily (OD) administration of 60 mg and 100 mg phenobarbital, in reducing seizure frequency in participants with partial onset seizures (Type I seizures; complex or simple with motor symptoms only) not fully controlled despite treatment with 1 to 3 concomitant anti-epileptic drugs (AEDs) or AEDs with Vagus Nerve Stimulator (VNS) Secondary: to confirm dose response relationship of 60 and 100 mg phenobarbital doses, to assess the effects of phenobarbital on Type I seizures, to assess the safety of phenobarbital to assess the tolerability of phenobarbital

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
partial onset seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
314 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo tablets
Arm Title
60 mg group
Arm Type
Experimental
Arm Description
Patients titrated to 60mg phenobarbital for maintenance period, then titrated down.
Arm Title
100 mg group
Arm Type
Experimental
Arm Description
Patients titrated to 100mg phenobarbital maintenance period, then titrated down
Intervention Type
Drug
Intervention Name(s)
Phenobarbital
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Placebo tablet
Intervention Description
tablet
Primary Outcome Measure Information:
Title
Evaluate the efficacy of OD administration of 60 mg and 100 mg phenobarbital in reduction of seizure frequency
Description
determination of partial onset seizure frequency per week over the treatment period comparison of average change in weekly seizure rate from baseline and maintenance period
Time Frame
34 weeks with maximum 22-week exposure to phenobarbital
Secondary Outcome Measure Information:
Title
Confirm the dose response relationship of 60 mg and 100 mg phenobarbital doses
Time Frame
34 weeks with a maximum 22-week exposure to phenobarbital
Title
Assess the effects of phenobarbital on Type I seizures
Description
seizure freedom rate percent reduction for partial onset seizure responder rate reduction of seizure frequency
Time Frame
34 weeks with a maximum 22-week exposure to phenobarbital
Title
Assess the safety of phenobarbital
Description
overview of adverse events in study summary of adverse events in study by severity, seriousness, relationship to study drug, action taken, outcome, treatment summary of serious adverse events
Time Frame
34 weeks with a maximum 22-week exposure to phenobarbital
Title
Assess the tolerability of phenobarbital
Time Frame
34 weeks with maximum 22-week exposure to phenobarbital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: participants from 17 to 70 years old; history of Type I partial onset seizures (complex or simple with motor symptoms only); participants must have had electroencephalogram (EEG), magnetic resonance imaging (MRI) or computed tomography (CT) with results consistent with diagnosis of partial-onset seizures; participants having at least eight Type I partial onset seizures during 8-week baseline period; participants being uncontrolled while treated by 1 to 3 permitted concomitant anti-epileptic drug (AED) and/or Vagus Nerve Stimulation (VNS); participant has been on a stable dose of their current anti-epileptic treatment regime Exclusion Criteria: currently taking phenobarbital or primidone; currently taking felbamate or vigabatrin; history of prior allergic reaction to phenobarbital; history of psychogenic seizures; history or presence of status epilepticus; history or presence of seizures occurring only in clusters; participant taking any drug with possible Central Nervous System (CNS) effects except if stable from 1 month prior Visit 1; history of cerebrovascular accident (CVA) or transient ischemic attack (TIA); presence of any sign suggesting rapidly progressing brain disorder or brain tumor; presence of unstable arteriovenous malformations, meningiomas or other benign tumors; history of porphyria; presence of clinically significant findings on physical exam, vital signs, electrocardiogram (ECG) or safety lab assessments, including renal or hepatic insufficiency; history of alcohol or drug abuse within the year prior to screening; participant who is known to be non-compliant; participant who is male or female who refuses to use an acceptable form of contraception; female who is pregnant or lactating or intends to become pregnant; participant who has taken part in any investigational device or product within 2 months prior to the screening visit
Facility Information:
Facility Name
Bluegrass Epilepsy Research
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Centro Neurodiagnostico
City
Rio Piedras
ZIP/Postal Code
00924
Country
Puerto Rico
Facility Name
Hospital Del Maestro
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico

12. IPD Sharing Statement

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Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures

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