Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT01284556
Status:
COMPLETED
Last Update Posted:
2017-11-14
First Post:
2011-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures
Sponsor:
West-Ward Pharmaceutical
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
\- 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
-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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010-020871-22 | EUDRACT_NUMBER | None | View |