Fampridine Pregnancy Exposure Registry
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Women's Studies, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/21/2015 |
| Start Date: | December 2015 |
| End Date: | October 2020 |
| Contact: | Biogen |
| Email: | clinicaltrials@biogen.com |
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.
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.
There are no mandatory physician visits. The registry will collect pregnancy outcome data
from the participants health care provider during the prenatal follow up (6-7 months
gestation), pregnancy outcome (4 weeks after estimated delivery date) and finally the
pediatric follow up (at 4 weeks and 12 weeks post birth).
from the participants health care provider during the prenatal follow up (6-7 months
gestation), pregnancy outcome (4 weeks after estimated delivery date) and finally the
pediatric follow up (at 4 weeks and 12 weeks post birth).
Key Inclusion Criteria:
- Documentation that the patient was exposed to prolonged-release fampridine since the
first day of her last menstrual period (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.
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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