Fampridine Pregnancy Exposure Registry

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis; Pregnancy
• Intervention / Treatment: Drug: Fampridine

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 Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Hôpital Pitié Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study population will be pregnant female participants with multiple sclerosis who have been exposed to prolonged release fampridine since the first day of the last menstrual period or at any time during pregnancy. This information will be from ongoing fampridine clinical studies or the post-marketing setting. The outcome of the pregnancy must not be known at the time of report.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Spontaneous abortions	< 22 weeks of gestation
Elective or therapeutic terminations	Up to 9 months of pregnancy
Ectopic pregnancy	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)
Premature births	Delivered before 37 Weeks of gestation
Maternal death	During pregnancy, labor or delivery
Neonatal death	Prior to 28 days of life
Birth Defects	Delivery time (expected 9 months of pregnancy)

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: December 15, 2011
• First Submitted That Met QC Criteria: February 13, 2012
• First Posted (Estimate): February 14, 2012

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 17, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Potassium Channel Blockers; 4-Aminopyridine
• Other Study ID Numbers: 218MS402