Fampridine Pregnancy Exposure Registry
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Purpose
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.
| Condition |
|---|
|
Multiple Sclerosis Pregnancy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Fampridine Pregnancy Exposure Registry |
- Spontaneous abortions [ Time Frame: < 22 weeks of gestation ] [ Designated as safety issue: Yes ]
- Elective or therapeutic terminations [ Time Frame: Upto 9 months of pregnancy ] [ Designated as safety issue: Yes ]
- Ectopic pregnancy [ Time Frame: Upto 9 months of pregnancy ] [ Designated as safety issue: Yes ]
- Fetal death including still births [ Time Frame: >22 weeks of gestation or weighing 500 grams ] [ Designated as safety issue: Yes ]
- Live born infants [ Time Frame: During delivery time ( at expected average 9 months of pregnancy) ] [ Designated as safety issue: Yes ]
- Premature births [ Time Frame: Delivered before 37 Weeks of gestation ] [ Designated as safety issue: Yes ]
- Maternal death [ Time Frame: Upto 10 months of pregnancy ] [ Designated as safety issue: Yes ]
- Neonatal death [ Time Frame: Prior to 28 days of life ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 375 |
| Estimated Study Completion Date: | January 2017 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
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).
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- Documentation that the patient was exposed to prolonged-release fampridine since the first day of her LMP prior to conception or at any time during pregnancy. (If exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure.)
- The outcome of the pregnancy must not be known at the time of report.
Exclusion Criteria:
- None
Contacts and Locations| Contact: Medical Director | neurologyclinicaltrials@biogenidec.com |
| Germany | |
| Research Site | Recruiting |
| Bochum, Germany | |
More Information
No publications provided
| Responsible Party: | Biogen Idec Ltd, Medical Director |
| ClinicalTrials.gov Identifier: | NCT01532154 History of Changes |
| Other Study ID Numbers: | 218MS402 |
| Study First Received: | December 15, 2011 |
| Last Updated: | June 28, 2012 |
| Health Authority: | Germany: Ethics Commission European Union: European Medicines Agency |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013