Fampridine Pregnancy Exposure Registry

Biogen1 site in 1 country1 target enrollmentAugust 2015

ConditionsMultiple Sclerosis Pregnancy

DrugsFampridine

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple Sclerosis
Sponsor: Biogen
Enrollment: 1
Locations: 1
Primary Endpoint: Maternal death
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

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).

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

February 2016

Last Updated

9 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Biogen

Responsible Party

Sponsor

Eligibility Criteria

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.