Catamenial EpilepsyNCT00559169
Verapamil and Catamenial Epilepsy
A study testing verapamil hyrochloride in people with Catamenial Epilepsy, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
One in 3 epilepsy patients have refractory seizures. This drug resistance is likely related to the over expression of multidrug resistance proteins (MDR). Progesterone is a known inhibitor of MDRs and the low level of this hormone during the menstrual cycle may exacerbate seizures, perhaps explaining catamenial… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Catamenial Epilepsy
- What is being tested?
- verapamil hyrochloride
- Type of treatment
- Pill or oral medicine
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to Dec 2010
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- females
- at least 2 seizures per month
- more than 50% of the seizures occur 7 days before or 7 days after the onset of menses
- patient of the Toronto Western Hospital Epilepsy Clinic
Who cannot join
- cardiovascular history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Verapamil in Refractory Catamenial Epilepsy
One in 3 epilepsy patients have refractory seizures. This drug resistance is likely related to the over expression of multidrug resistance proteins (MDR). Progesterone is a known inhibitor of MDRs and the low level of this hormone during the menstrual cycle may exacerbate seizures, perhaps explaining catamenial epilepsy; i.e. seizures occurring during the menstrual cycle. Verapamil suppresses seizures in animal models of epilepsy perhaps by inhibiting MDRs and thus may help patients with refractory seizures. If the study shows improved seizure control, the results will help establish the role of MDRs in refractory epilepsy.
- Conditions
- Catamenial Epilepsy
- Being tested
- verapamil hyrochloride
- Keywords
- epilepsy, seizures, menstrual cycle
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
verapamil hyrochlorideDrug
Also called apo-verap, isoptin
80 mg daily by mouth, 5 days prior to menses for 3 months
What is being measured
The primary outcome is the main question the study is designed to answer.
the percent reduction in seizure frequency
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startFeb 2009
- Study completionDec 2010 (estimated)
Why it stopped: protocol changed and a new study using verapamil in epilepsy will be started in the near future
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catamenial EpilepsyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Danielle Andrade, MD, Principal investigator, College of Physicians and Surgeons of Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559169
- Sponsor's protocol ID
- UHN-TWH-VER-001
- Status last verified
- Nov 2007
- First submitted
- 14 Nov 2007
- Last updated
- 8 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Verapamil in Refractory Catamenial Epilepsy
- ClinicalTrials.gov ID
- NCT00559169
- Acronym / sponsor ID
- UHN-TWH-VER-001
- Conditions
- Catamenial Epilepsy
- Keywords
- epilepsy, seizures, menstrual cycle
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: protocol changed and a new study using verapamil in epilepsy will be started in the near future
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Feb 2009
- Study completion
- Dec 2010 (estimated)
- First posted
- 16 Nov 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.
One in 3 epilepsy patients have refractory seizures. This drug resistance is likely related to the over expression of multidrug resistance proteins (MDR). Progesterone is a known inhibitor of MDRs and the low level of this hormone during the menstrual cycle may exacerbate seizures, perhaps explaining catamenial epilepsy; i.e. seizures occurring during the menstrual cycle. Verapamil suppresses seizures in animal models of epilepsy perhaps by inhibiting MDRs and thus may help patients with refractory seizures. If the study shows improved seizure control, the results will help establish the role of MDRs in refractory epilepsy.
Study design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- females
- at least 2 seizures per month
- more than 50% of the seizures occur 7 days before or 7 days after the onset of menses
- patient of the Toronto Western Hospital Epilepsy Clinic
Key exclusion criteria (1 listed)
- cardiovascular history
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 |
|---|---|---|
| verapamil hyrochlorideAlso: apo-verap, isoptin80 mg daily by mouth, 5 days prior to menses for 3 months | Drug | – |
Primary outcome
the percent reduction in seizure frequency
Time frame: 3 months
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 8 Apr 2010.
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.
Danielle Andrade, MD principal investigator
College of Physicians and Surgeons of Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing verapamil hyrochloride in people with Catamenial Epilepsy, run by University Health Network, Toronto at 1 site in Canada.
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 4 inclusion and 1 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 8 Apr 2010. 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 Canada. 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. 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?
the percent reduction in seizure frequency (time frame: 3 months). 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 8 Apr 2010.