Fampridine Pregnancy Exposure Registry

Biogen

Status: Terminated

Conditions: Multiple Sclerosis; Pregnancy

Treatments: Drug: Fampridine

Study type: Observational

Funder types: Industry

Identifiers

NCT01532154

218MS402

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1 patient

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

• None

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.