EpilepsyPhase 3NCT01284556
Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures
A Phase 3 study testing Phenobarbital in people with Epilepsy, run by West-Ward Pharmaceutical at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Phenobarbital
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 314 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Nov 2010to Apr 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- participants from 17 to 70 years old;
- history of Type I partial onset seizures (complex or simple with motor symptoms only);
- participants must have had electroencephalogram (EEG), magnetic resonance imaging (MRI) or computed tomography (CT) with results consistent with diagnosis of partial-onset seizures;
- participants having at least eight Type I partial onset seizures during 8-week baseline period;
- participants being uncontrolled while treated by 1 to 3 permitted concomitant anti-epileptic drug (AED) and/or Vagus Nerve Stimulation (VNS);
- participant has been on a stable dose of their current anti-epileptic treatment regime
Who cannot join
- currently taking phenobarbital or primidone;
- currently taking felbamate or vigabatrin;
- history of prior allergic reaction to phenobarbital;
- history of psychogenic seizures;
- history or presence of status epilepticus;
- history or presence of seizures occurring only in clusters;
Show all 17Show fewer
- participant taking any drug with possible Central Nervous System (CNS) effects except if stable from 1 month prior Visit 1;
- history of cerebrovascular accident (CVA) or transient ischemic attack (TIA);
- presence of any sign suggesting rapidly progressing brain disorder or brain tumor;
- presence of unstable arteriovenous malformations, meningiomas or other benign tumors;
- history of porphyria;
- presence of clinically significant findings on physical exam, vital signs, electrocardiogram (ECG) or safety lab assessments, including renal or hepatic insufficiency;
- history of alcohol or drug abuse within the year prior to screening;
- participant who is known to be non-compliant;
- participant who is male or female who refuses to use an acceptable form of contraception;
- female who is pregnant or lactating or intends to become pregnant;
- participant who has taken part in any investigational device or product within 2 months prior to the screening visit
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Bluegrass Epilepsy Research
Lexington, Kentucky, 40504
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Puerto Rico2 sites
Centro Neurodiagnostico
Rio Piedras, 00924
Hospital Del Maestro
San Juan, PR, 00927
About this study
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
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.
Read the 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
- Conditions
- Epilepsy
- Being tested
- Phenobarbital, Placebo tablet
- Keywords
- partial onset seizures
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenobarbitalDrug
tablet
Placebo tabletDrug
tablet
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo tablets Receives: Drug: Placebo tablet |
| 60 mg group | Experimental | Patients titrated to 60mg phenobarbital for maintenance period, then titrated down. Receives: Drug: Phenobarbital |
| 100 mg group | Experimental | Patients titrated to 100mg phenobarbital maintenance period, then titrated down Receives: Drug: Phenobarbital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of OD administration of 60 mg and 100 mg phenobarbital in reduction of seizure frequency
- 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
Measured: 34 weeks with maximum 22-week exposure to phenobarbital
Secondary outcomes (4)
Confirm the dose response relationship of 60 mg and 100 mg phenobarbital doses
Measured: 34 weeks with a maximum 22-week exposure to phenobarbital
Assess the effects of phenobarbital on Type I seizures
- seizure freedom rate
- percent reduction for partial onset seizure
- responder rate
- reduction of seizure frequency
Measured: 34 weeks with a maximum 22-week exposure to phenobarbital
Assess the safety of 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
Measured: 34 weeks with a maximum 22-week exposure to phenobarbital
Assess the tolerability of phenobarbital
Measured: 34 weeks with maximum 22-week exposure to phenobarbital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionJan 2013
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- West-Ward Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284556
- Sponsor's protocol ID
- AGG-901
- Other IDs
- 2010-020871-22
- Status last verified
- Nov 2017
- First submitted
- 20 Jan 2011
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01284556
- Acronym / sponsor ID
- AGG-901
- Conditions
- Epilepsy
- Keywords
- partial onset seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- West-Ward PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo tabletplacebo tablets |
| 60 mg group | Experimental | Drug: PhenobarbitalPatients titrated to 60mg phenobarbital for maintenance period, then titrated down. |
| 100 mg group | Experimental | Drug: PhenobarbitalPatients titrated to 100mg phenobarbital maintenance period, then titrated down |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- participants from 17 to 70 years old;
- history of Type I partial onset seizures (complex or simple with motor symptoms only);
- participants must have had electroencephalogram (EEG), magnetic resonance imaging (MRI) or computed tomography (CT) with results consistent with diagnosis of partial-onset seizures;
- participants having at least eight Type I partial onset seizures during 8-week baseline period;
- participants being uncontrolled while treated by 1 to 3 permitted concomitant anti-epileptic drug (AED) and/or Vagus Nerve Stimulation (VNS);
Key exclusion criteria (17 listed)
- currently taking phenobarbital or primidone;
- currently taking felbamate or vigabatrin;
- history of prior allergic reaction to phenobarbital;
- history of psychogenic seizures;
- history or presence of status epilepticus;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenobarbitaltablet | Drug | 100 mg group, 60 mg group |
| Placebo tablettablet | Drug | Placebo |
Primary outcome
Evaluate the efficacy of OD administration of 60 mg and 100 mg phenobarbital in reduction of seizure frequency
Time frame: 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
4 secondary outcomes
Confirm the dose response relationship of 60 mg and 100 mg phenobarbital doses
Time frame: 34 weeks with a maximum 22-week exposure to phenobarbital
Assess the effects of phenobarbital on Type I seizures
Time frame: 34 weeks with a maximum 22-week exposure to phenobarbital
Assess the safety of phenobarbital
Time frame: 34 weeks with a maximum 22-week exposure to phenobarbital
Assess the tolerability of phenobarbital
Time frame: 34 weeks with maximum 22-week exposure to phenobarbital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phenobarbital in people with Epilepsy, run by West-Ward Pharmaceutical at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of OD administration of 60 mg and 100 mg phenobarbital in reduction of seizure frequency (time frame: 34 weeks with maximum 22-week exposure to phenobarbital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.