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ClinicalTrials.gov Identifier: NCT01532154
Recruitment Status :
(Due to low enrollment, registration closed in agreement with the Regulatory Agency)
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 or disease
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).
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The study population will be pregnant female participants with multiple sclerosis who have been exposed to prolonged release fampridine since the first day of the last menstrual period or at any time during pregnancy. This information will be from ongoing fampridine clinical studies or the post-marketing setting. The outcome of the pregnancy must not be known at the time of report.
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.