Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
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.
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
Study:
NCT01284556
Study Brief:
Protocol Section:
NCT01284556