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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 14, 2007 | ||||||||
| Last Updated Date | November 14, 2007 | ||||||||
| Start Date ICMJE | February 2008 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
the percent reduction in seizure frequency [ Time Frame: 3 months ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Verapamil and Catamenial Epilepsy | ||||||||
| Official Title ICMJE | Study of Verapamil in Refractory Catamenial Epilepsy | ||||||||
| Brief 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 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. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Catamenial Epilepsy | ||||||||
| Intervention ICMJE | Drug: verapamil hyrochloride | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 12 | ||||||||
| Estimated Completion Date | December 2010 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00559169 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | UHN-TWH-VER-001 | ||||||||
| Study Sponsor ICMJE | University Health Network, Toronto | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | University Health Network, Toronto | ||||||||
| Verification Date | November 2007 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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