Trial record 83 of 146 for:
epilepsy AND Bethesda
Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03208660 |
Recruitment Status :
Completed
First Posted : July 5, 2017
Last Update Posted : April 11, 2019
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Sponsor:
Eisai Inc.
Information provided by (Responsible Party):
Eisai Inc.
Tracking Information | |||||
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First Submitted Date | July 3, 2017 | ||||
First Posted Date | July 5, 2017 | ||||
Last Update Posted Date | April 11, 2019 | ||||
Actual Study Start Date | April 7, 2017 | ||||
Actual Primary Completion Date | March 15, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Percentage of participants remaining on Fycompa treatment at specified time points after initiation of treatment (Retention rate) [ Time Frame: 3, 6, 12, 18, and 24 months ] Retention rate is the ratio of the number of participants remaining on Fycompa treatment to the number of participants who could have been exposed for that length of time.
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Original Primary Outcome Measures | Same as current | ||||
Change History | Complete list of historical versions of study NCT03208660 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy | ||||
Official Title | A Retrospective Multicenter Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy | ||||
Brief Summary | This study is conducted to assess the retention rate of Fycompa when given in routine clinical care. | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Data will be obtained by reviewing the medical records of the participants with a diagnosis of epilepsy and treated with Fycompa on clinician's recommendation at up to approximately 40 epilepsy centers. | ||||
Condition | Epilepsy | ||||
Intervention | Drug: Fycompa
Oral suspension
Other Name: Perampanel
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Study Groups/Cohorts | Fycompa
Participants diagnosed with epilepsy and treated with Fycompa
Intervention: Drug: Fycompa
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Publications * | Not Provided | ||||
* 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 | Completed | ||||
Actual Enrollment |
2000 | ||||
Original Estimated Enrollment | Same as current | ||||
Actual Study Completion Date | March 15, 2019 | ||||
Actual Primary Completion Date | March 15, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03208660 | ||||
Other Study ID Numbers | E2007-G000-506 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | Eisai Inc. | ||||
Study Sponsor | Eisai Inc. | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | Eisai Inc. | ||||
Verification Date | March 2019 |