Fampridine Pregnancy Exposure Registry
| Tracking Information | |||||
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| First Received Date ICMJE | December 15, 2011 | ||||
| Last Updated Date | June 28, 2012 | ||||
| Start Date ICMJE | Not Provided | ||||
| Estimated Primary Completion Date | December 2016 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01532154 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 | Fampridine Pregnancy Exposure Registry | ||||
| Official Title ICMJE | Fampridine Pregnancy Exposure Registry | ||||
| Brief Summary | This is a global pregnancy registry to evaluate the outcomes of pregnancy in women with multiple sclerosis who have been exposed to prolonged release fampridine since the first day of their last menstrual period prior to conception or at any time during pregnancy. |
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| Detailed Description | This is a global pregnancy registry to evaluate the outcomes of pregnancy in women with multiple sclerosis who have been exposed to prolonged release fampridine since the first day of their last menstrual period prior to conception or at any time during pregnancy. Approximately 375 prolonged release fampridine exposed pregnancies wil be enrolled. There are no mandatory physician visits. The registry will collect pregnancy oucome data from the patients health care provider during the the prenatal follow up (6-7 months gestation), pregancy outcome (4 weeks after estimated delivery date) and finally the pediatric follow up (at 4 weeks and 12 weeks post birth). |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | The study poulation will be female patients who have been exposed to prolonged release fampridine since the first day of the last menstrual period. This information will be from ongoing fampridine clinical studies and spontaneous medical reports received from health care providers. |
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| Condition ICMJE |
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| 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 375 | ||||
| Estimated Completion Date | January 2017 | ||||
| Estimated Primary Completion Date | December 2016 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01532154 | ||||
| Other Study ID Numbers ICMJE | 218MS402 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Biogen Idec Ltd, Medical Director | ||||
| Study Sponsor ICMJE | Biogen Idec | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Biogen Idec | ||||
| Verification Date | June 2012 | ||||
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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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