Quality of Life and Adverse Effects in Epilepsy Patients (EPIKA)
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00302991
First received: March 13, 2006
Last updated: January 29, 2008
Last verified: January 2008
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 13, 2006 | ||||
| Last Updated Date | January 29, 2008 | ||||
| Start Date ICMJE | March 2006 | ||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00302991 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Quality of Life and Adverse Effects in Epilepsy Patients (EPIKA) | ||||
| Official Title ICMJE | Quality of Life and Adverse Effects in Epilepsy Patients According to Treatment Group (EPIKA) | ||||
| Brief Summary | Observational, multicentre, epidemiological study to determine the HRQOL of patients with epilepsy according to treatment sub-group and to validate the Spanish version of the Adverse Events Profile, produced by G. Baker et al. Three treatment groups will be examined: patients receiving only a new anti-epilepsy drug (AED), patients receiving a "classic" AED; patients receiving combination therapy. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE | Epilepsy | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 180 | ||||
| Completion Date | October 2007 | ||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Spain | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00302991 | ||||
| Other Study ID Numbers ICMJE | N01247, EPIKA | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Study Director, UCB | ||||
| Study Sponsor ICMJE | UCB, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | UCB, Inc. | ||||
| Verification Date | January 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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