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NCT01284556 · ClinicalTrials.gov registry record · Phase 3
Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures
A Phase 3 study, sponsored by West-Ward Pharmaceutical.
- Completed
- Registry status
- Phase 3
- Development phase
- 314
- Enrollment target
NCT01284556: Completed Phase 3 study, sponsored by West-Ward Pharmaceutical.
NCT01284556 is a Phase 3 study that has completed, run by West-Ward Pharmaceutical. The registered enrollment target is 314 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01284556, a Phase 3 study, has completed, sponsored by West-Ward Pharmaceutical.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 314 participants
- Enrollment target
Study 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.
Primary Outcome
* 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
Interventions
- DRUG Placebo tablet
- DRUG Phenobarbital
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2010-11 |
| Est. Completion | 2016-04 |
| Phase | Phase 3 |
What the finished NCT01284556 record still lists
NCT01284556 is an interventional study that assigns participants to a tested intervention. The registered 314 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo tablet is the first listed.
NCT01284556 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01284556 about?
NCT01284556 is a clinical study titled "Evaluation Phenobarbital as Adjunctive Therapy in Participants 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.
What is the current status of trial NCT01284556?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 314 participants. The study started on 2010-11. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01284556?
The interventions under investigation include: Placebo tablet (DRUG), Phenobarbital (DRUG).
Who is sponsoring clinical trial NCT01284556?
This trial is sponsored by West-Ward Pharmaceutical, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01284556's enrollment target sits among peer trials
314 1096th of 2000 higher than 900 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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