Trial · NCT01284556
Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures
NCT01284556, Phase 3, Completed, West-Ward Pharmaceutical
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures. Trials, record NCT01284556. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01284556
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures
- NCT number
- NCT01284556
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 314 participants, actual
- Lead sponsor
- West-Ward Pharmaceutical
- Conditions
- Epilepsy
- Interventions
- Phenobarbital, Placebo tablet
- First posted
- 2011-01-27
- Last updated
- 2017-11-14
- Other registries' IDs
- eudract:2010-020871-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate the efficacy of OD administration of 60 mg and 100 mg phenobarbital in reduction of seizure frequency | 34 weeks with maximum 22-week exposure to phenobarbital | * 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 |
| Secondary | Confirm the dose response relationship of 60 mg and 100 mg phenobarbital doses | 34 weeks with a maximum 22-week exposure to phenobarbital | |
| Secondary | Assess the effects of phenobarbital on Type I seizures | 34 weeks with a maximum 22-week exposure to phenobarbital | * seizure freedom rate * percent reduction for partial onset seizure * responder rate * reduction of seizure frequency |
| Secondary | Assess the safety of phenobarbital | 34 weeks with a maximum 22-week exposure to phenobarbital | * 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 |
| Secondary | Assess the tolerability of phenobarbital | 34 weeks with maximum 22-week exposure to phenobarbital |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01284556
GET https://conductscience.org/api/trials/v1/NCT01284556/registered