Fampridine Pregnancy Exposure Registry

Terminated

• Conditions: Multiple Sclerosis; Pregnancy

• Registration Number: NCT01532154
• Lead Sponsor: Biogen

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).

Study Timeline

• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2012-02-13
• Study First Posted: 2012-02-14
• Study Start: 2015-08
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal death	During pregnancy, labor or delivery
Elective or therapeutic terminations	Up to 9 months of pregnancy
Fetal death including still births	>22 weeks of gestation or weighing 500 grams
Live born infants	During delivery time ( at expected average 9 months of pregnancy)
Neonatal death	Prior to 28 days of life
Birth Defects	Delivery time (expected 9 months of pregnancy)
Ectopic pregnancy	Up to 9 months of pregnancy
Spontaneous abortions	< 22 weeks of gestation
Premature births	Delivered before 37 Weeks of gestation

Trial Locations

Locations (1)

Hopital Pitie Salpetriere; 🇫🇷 Paris, France