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Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
West-Ward Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01284556
First received: January 20, 2011
Last updated: May 27, 2014
Last verified: May 2014

January 20, 2011
May 27, 2014
November 2010
March 2013   (final data collection date for primary outcome measure)
Evaluate the efficacy of OD administration of 60 mg and 100 mg phenobarbital in reduction of seizure frequency [ Time Frame: 34 weeks with maximum 22-week exposure to phenobarbital ] [ Designated as safety issue: No ]
  • 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
Same as current
Complete list of historical versions of study NCT01284556 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Assess the effects of phenobarbital on Type I seizures [ Time Frame: 34 weeks with a maximum 22-week exposure to phenobarbital ] [ Designated as safety issue: No ]
    • seizure freedom rate
    • percent reduction for partial onset seizure
    • responder rate
    • reduction of seizure frequency
  • Assess the safety of phenobarbital [ Time Frame: 34 weeks with a maximum 22-week exposure to phenobarbital ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 34 weeks with maximum 22-week exposure to phenobarbital ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures
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

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.

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Epilepsy
  • Drug: Phenobarbital
    tablet
  • Drug: Placebo tablet
    tablet
  • Placebo Comparator: Placebo
    placebo tablets
    Intervention: Drug: Placebo tablet
  • Experimental: 60 mg group
    Patients titrated to 60mg phenobarbital for maintenance period, then titrated down.
    Intervention: Drug: Phenobarbital
  • Experimental: 100 mg group
    Patients titrated to 100mg phenobarbital maintenance period, then titrated down
    Intervention: Drug: Phenobarbital
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
345
October 2014
March 2013   (final data collection date for primary outcome measure)

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
Both
17 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01284556
AGG-901, 2010-020871-22
Yes
West-Ward Pharmaceutical
West-Ward Pharmaceutical
Not Provided
Not Provided
West-Ward Pharmaceutical
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP