NCT01532154

Fampridine Pregnancy Exposure Registry

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: Biogen · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Multiple Sclerosis
• Pregnancy

Interventions

Type	Name	Description
DRUG	Fampridine	As prescribed and taken after the last menstrual period prior to becoming pregnant or anytime during the pregnancy

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2012-02-14
• Last updated: 2016-10-18

Locations

1 site across 1 country: France