Epilepsy with partial onset seizures (complex or simple with motor symptoms only) whether or not secondarily generalized. MedDRA version: 13.1 Level: LLT Classification code 10015037 Term:
Conditions
Interventions
Product Name: Phenobarbital
Product Code: Phenobarbital
Pharmaceutical Form: Tablet
INN or Proposed INN: Phenobarbital
CAS Number: 50-06-6
Current Sponsor code: Phenobarbital
Other descriptive name:
Sponsors
West-ward Pharmaceutical Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Participants from 17 to 70 years (inclusive); 2) Participants with a history of Type I partial onset seizures (complex or simple [with motor symptoms only]; according to the ILAE classification; 1981) whether or not secondarily generalized; 3) Participants must have had, within the last 10 years, one electroencephalogram (EEG) or video EEG and/or one brain magnetic resonance imaging (MRI) or computerized tomography (CT) with results consistent with a diagnosis of partial-onset seizures. If these have not been performed in the last 10 years, or if the records of these are not available, an EEG and CT or MRI will be performed as part of the screening procedures; 4) Participants having at least eight Type I partial onset seizures (complex or simple [with motor symptoms only]) whether or not secondarily generalized, during the 8-week Baseline Period 5) Participants being uncontrolled while treated by 1 to 3 permitted concomitant AED(s) and/or Vagus Nerve Stimulation (if participant is treated with VNS for at least 6 months prior to the start of the study, this will count as one of the three permitted concomitant treatments); and 6) Participant has been on a stable dose of their current anti-epileptic treatment regime for at least 1 month prior to screening and VNS settings must have been unchanged for at least 1 month Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Currently taking phenobarbital or primidone (accepted if they have been off for a month prior to study screening); 2. Currently taking felbamate or vigabatrin and all prescription medication listed in section 11.6 Prohibited Medication. 3. History of prior allergic reaction to phenobarbital; 4. History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 3; 5. History or presence of status epilepticus during the year preceding Visit 1 or during baseline; 6. History of psychogenic seizures; 7. Participant taking any drug with possible relevant CNS effects except if stable from at least 1 month before Visit 1 and expected to be kept stable during the Treatment Period; 8. History of cerebrovascular accident (CVA), including transient ischemic attack (TIA), in the last 6 months; 9. Presence of any sign (clinical or imaging techniques) suggesting rapidly progressing (ie, not expected to stay stable during study participation) brain disorder or brain tumor; 10. Presence of unstable arteriovenous malformations, meningiomas or other benign tumors. Stable lesions such as these may be acceptable; 11. History of porphyria; 12. Presence of clinically significant findings on physical examination, vital signs, electrocardiogram, or safety laboratory assessments, including, but not limited to, either renal or hepatic insufficiency; 13. History of alcohol or drug abuse within the year prior to the screening visit as defined by the DSM IV TR criteria; 14. Participant who is known to be non-compliant with their current regime of anti-epileptic drugs; 15. Participant is a male or female of child-bearing potential who refuses to use an acceptable form of contraception during the study, ‘ 16. Female participant who is pregnant or lactating or participant intends to become pregnant during the study. (Females who are surgically sterilized or have been post-menopausal for at least 2 years are not considered to be of child-bearing potential.) For the purposes of this study, acceptable forms of birth control include, double-barrier methods (e.g. use of condom and spermicide), intrauterine device, and abstinence with second acceptable method should participant become sexually active; or 17. Participant has taken part in any trial with any investigational device or product within the 2 months prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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; according International League Against Epilepsy [ILAE]) not fully controlled despite treatment with 1 to 3 concomitant anti-epileptic drugs (AEDs) or AEDs with Vagus Nerve Stimulator (VNS).;Secondary Objective: • To confirm the dose response relationship of 60 mg and 100 mg phenobarbital doses; • To assess the effects of phenobarbital on Type I seizures; and • To assess the safety and tolerability of phenobarbital. ;Primary end point(s): The primary efficacy variable is the partial onset seizure (Type I; complex or simple [with motor symptoms only]) frequency per week over the Treatment Period, excluding up- and down-titration periods. | — |
Countries
Bulgaria
Outcome results
None listed