EpilepsyNCT00530413
Study of Phenobarbital Inhibition of Catamenial Epilepsy
A study testing Phenobarbital in people with Epilepsy, run by University of Toledo Health Science Campus at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of low-dose Phenobarbital on the treatment of catamenial epilepsy. We propose that since the catamenial seizures are associated with the reduction in levels of GABA-enhancing allopregnanolone, short-term replacement with the GABAR-enhancing agent Phenobarbital… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Epilepsy
- What is being tested?
- Phenobarbital
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Mar 2009
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adult female patients seeking medical attention for seizures
- Regular menstrual cycles
- At least 2 seizures per month
- Must be on at least one form of birth control other than abstinence
- Must be on a stable anticonvulsant regimen of at least one and not exceeding three anticonvulsants, and not be using any perimenstrual seizure medications of hormone preparations
- If taking benzodiazepines for therapeutic purposes, must be on a stable regular dose
- Must be willing to take at least 400mcg of folic acid a day while in the study
- Must be able to detect, count or record seizures
Who cannot join
- Can not be pregnant or trying to become pregnant
- Can not have used hormonal birth control methods for at least 3 months prior to enrollment
- Can not have an allergy to Phenobarbital
- Can not have a history of non-epileptic seizures
- Can not have a know liver dysfunction or history of chronic hepatitis
- Can not have a history of neurological disorder or history of status epilepticus in the preceding year
- Can not ahve a physical or psychiatric condition which in the PIs opinion could compromise her ability to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Toledo, Health Science Campus
Toledo, Ohio, 43606
About this study
The purpose of this study is to test the effectiveness of low-dose Phenobarbital on the treatment of catamenial epilepsy.
We propose that since the catamenial seizures are associated with the reduction in levels of GABA-enhancing allopregnanolone, short-term replacement with the GABAR-enhancing agent Phenobarbital will reduce the incidence of catamenial seizures.
- Conditions
- Epilepsy
- Being tested
- Phenobarbital, Placebo
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenobarbitalDrug
Phenobarbital will be given based on weight range
PlaceboOther
Placebo group
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Phenobarbital - dose based by weight range Receives: Drug: Phenobarbital |
| 2 | Placebo comparator | Placebo group Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9)
Measured: Screening, 3 month and final visit
Depression Epworth Sleepiness Scale (ESS)
Measured: Screening, 3 month and final visit
Quality of Life in Epilepsy (QOLIE-10)
Measured: Screening, 3 month and Final Visit
Addenbrooke's Cognitive Examination (ACE)
Measured: Screening, 3 month and Final Visit
Secondary outcomes (1)
Determine tolerance of medication using the depression, cognitive and sleepiness screening tools listed above
Measured: Screening, 3 months, final visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2009 (estimated)
Why it stopped: IRB needs updated
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lazar J Greenfield, Jr, MD, PhD, Principal investigator, University of Toledo Health Science Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530413
- Sponsor's protocol ID
- xUTHSC-07
- Status last verified
- Dec 2014
- First submitted
- 13 Sep 2007
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Phenobarbital Inhibition of Catamenial Epilepsy
- ClinicalTrials.gov ID
- NCT00530413
- Acronym / sponsor ID
- xUTHSC-07
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB needs updated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2009 (estimated)
- First posted
- 17 Sep 2007 (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.
The purpose of this study is to test the effectiveness of low-dose Phenobarbital on the treatment of catamenial epilepsy.
We propose that since the catamenial seizures are associated with the reduction in levels of GABA-enhancing allopregnanolone, short-term replacement with the GABAR-enhancing agent Phenobarbital will reduce the incidence of catamenial seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PhenobarbitalPhenobarbital - dose based by weight range |
| 2 | Placebo comparator | Other: PlaceboPlacebo group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adult female patients seeking medical attention for seizures
- Regular menstrual cycles
- At least 2 seizures per month
- Must be on at least one form of birth control other than abstinence
- Must be on a stable anticonvulsant regimen of at least one and not exceeding three anticonvulsants, and not be using any perimenstrual seizure medications of hormone preparations
Key exclusion criteria (7 listed)
- Can not be pregnant or trying to become pregnant
- Can not have used hormonal birth control methods for at least 3 months prior to enrollment
- Can not have an allergy to Phenobarbital
- Can not have a history of non-epileptic seizures
- Can not have a know liver dysfunction or history of chronic hepatitis
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 |
|---|---|---|
| PhenobarbitalPhenobarbital will be given based on weight range | Drug | 1 |
| PlaceboPlacebo group | Other | 2 |
Primary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: Screening, 3 month and final visit
Depression Epworth Sleepiness Scale (ESS)
Time frame: Screening, 3 month and final visit
Quality of Life in Epilepsy (QOLIE-10)
Time frame: Screening, 3 month and Final Visit
Addenbrooke's Cognitive Examination (ACE)
Time frame: Screening, 3 month and Final Visit
1 secondary outcome
Determine tolerance of medication using the depression, cognitive and sleepiness screening tools listed above
Time frame: Screening, 3 months, final visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
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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.
Lazar J Greenfield, Jr, MD, PhD principal investigator
University of Toledo Health Science Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenobarbital in people with Epilepsy, run by University of Toledo Health Science Campus at 1 site in United States.
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 8 inclusion and 7 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: withdrawn, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Patient Health Questionnaire (PHQ-9) (time frame: Screening, 3 month and final visit). The study lists 4 primary outcomes in all. 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 10 Dec 2014.