Fampridine Pregnancy Exposure Registry

• Status: Terminated
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: 4-Aminopyridine

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.