NCT01284556

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_3

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

2.2 years

First QC Date

January 20, 2011

Last Update Submit

November 9, 2017

Conditions

Epilepsy

Keywords

partial onset seizures

Outcome Measures

Primary Outcomes (1)

  • 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

    34 weeks with maximum 22-week exposure to phenobarbital

Secondary Outcomes (4)

  • Confirm the dose response relationship of 60 mg and 100 mg phenobarbital doses

    34 weeks with a maximum 22-week exposure to phenobarbital

  • Assess the effects of phenobarbital on Type I seizures

    34 weeks with a maximum 22-week exposure to phenobarbital

  • Assess the safety of phenobarbital

    34 weeks with a maximum 22-week exposure to phenobarbital

  • Assess the tolerability of phenobarbital

    34 weeks with maximum 22-week exposure to phenobarbital

Study Arms (3)

Placebo

PLACEBO COMPARATOR

placebo tablets

Drug: Placebo tablet

60 mg group

EXPERIMENTAL

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

Drug: Phenobarbital

100 mg group

EXPERIMENTAL

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

Drug: Phenobarbital

Interventions

PhenobarbitalDRUG

tablet

100 mg group60 mg group
Placebo tabletDRUG

tablet

Placebo

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Bluegrass Epilepsy Research

Lexington, Kentucky, 40504, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Hospital Del Maestro

San Juan, PR, 00927, Puerto Rico

Location

Centro Neurodiagnostico

Rio Piedras, 00924, Puerto Rico

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Phenobarbital

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

BarbituratesPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2011

First Posted

January 27, 2011

Study Start

November 1, 2010

Primary Completion

January 1, 2013

Study Completion

April 1, 2016

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations

PR(2)US(2)